chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis. The patient was treated with KEFLEX. On an unknown date, the outcome of the injection site cellulitis was recovered/resolved. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: This case was reported by a licensed practical nurse (LPN). The age at vaccination was not reported. The patient received a dose of SHINGRIX in the left upper arm. On 4th September 2018, the patient was seen back at the physician's office for a cellulitis in the same region the vaccine was administered. The patient was prescribed KEFLEX and the cellulitis resolved without any complications. The reporter did not agree to be followed up.
vertigo episode 1 month after vaccine (5/12)  dizzyness for 8 weeks until 7/30.  dizzyness re-occurs after respiratory cold 9/20
This case was reported by a consumer and described the occurrence of rash in a 4 month old female pt who received Pediarix. The reporter is the mother of the pt. A physician or other health care professional has not verified this report. On 12/30/04, the received the 1st dose of Pediarix. At an unspecified time following the administration of the 1st dose of Pediarix, on 12/30/04, the pt experienced a fever of 100.5F. The fever resolved on an unspecified date on or before 3/11/05. On 3/11/05, the pt received the 2nd dose of Pediarix. This is longer than the recommended interval of 6 to 8 weeks between the 1st and 2nd doses of Pediarix. Approximately 1 day following the 2nd administration of Pediarix, on 3/12/05, the pt experienced a rash. The rashw resolved on 3/24/05.
Patient started having fever, cough, injection site pain (stiffness and red), runny nose, congestion which worsened throughout Saturday, 11/23/19. She went to the emergency department after work on Saturday evening. She was given antibiotics because she had infection at the injection site along with the other symptoms mentioned above.
Administered about 3:30pm and sent to observation area.  At roughly 4:40pm client started getting dizzy and closing eyes, color gone from skin with lips getting grayish-purple.  At 4:45pm client was going in getting "clamy" skin, sweating some.  I had him recline in a chair and administered 1 dose (0.3mg) epinephrine using an auto-injector pen and called for emergency services.  At 4:50pm blood pressure  was 125/80.  Client still coherent.  Had mentioned that he had not eaten that day so  gave him some saltine crackers and juice. Color started to return and emergency services arrived to take over.
1/4/11 No fever, rash all over body. Came in to office on 1/5/11 with diarrhea x 1 day, in am of visit cried x 1 hr- unusual/on exam normal except macular/papular rash over most of body, blanches with pressure.
Passed out; Felt terrible; Lump on the head; Sore back and neck; Sore back and neck; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 14:00 (Lot number: 33130BA) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "covid prior vaccination" (unspecified if ongoing). If other vaccine in four weeks was reported as unknown. No known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EWO170, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 31Aug2021, when the patient was 53 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 31Jul2021, when the patient was 53 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Dec2021 14:00, outcome "unknown", described as "Dose number: 3"; LOSS OF CONSCIOUSNESS (medically significant) with onset 17Dec2021 09:00, outcome "recovering", described as "Passed out"; FEELING ABNORMAL (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Felt terrible"; MASS (non-serious) with onset 17Dec2021 09:00, outcome "recovering", described as "Lump on the head"; NECK PAIN (non-serious), BACK PAIN (non-serious) all with onset 17Dec2021 09:00, outcome "recovering" and all described as "Sore back and neck". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative. Therapeutic measures were taken as a result of loss of consciousness, feeling abnormal, mass, neck pain, back pain. Patient said that like his first 2 doses, he felt fine for about 12 hours and then really bad for another 10 hours or so. He woke up and felt terrible, so he stayed in bed until 9 am. Finally, he decided to get up and take a shower. He passed out in the shower and woke up with a lump on the head, a sore back and neck. Treatment medication included chiropractor. The patient was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
c/o lightheadedness, palpitations. Reports that she went to ER later for TX with Benadryl and fluids. On 10/8/2013 - continues to report "not feeling right" since being vaccinated.
Injection site, muscle, body pain; Injection site, muscle, body pain; Injection site, muscle, body pain; Headaches; Tiredness; Feeling unwell; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Mar2021 02:00 (Lot number: EN6206) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (vaccination time: 13:00, DOSE 1, SINGLE , Lot number: EN6200 , Route of administration: Intramuscular , Vaccine location: Left arm), administration date: 18Feb2021, when the patient was 74 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), MYALGIA (non-serious), PAIN (non-serious) all with onset 12Mar2021 16:00, outcome "recovering" and all described as "Injection site, muscle, body pain"; HEADACHE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Headaches"; FATIGUE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Tiredness"; MALAISE (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Feeling unwell"; NAUSEA (non-serious) with onset 12Mar2021 16:00, outcome "recovering", described as "Nausea". Therapeutic measures were taken as a result of vaccination site pain, myalgia, pain, headache, fatigue, malaise.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified blood pressure medication within two weeks of vaccination. Therapeutic measures were taken as a result of the events (except nausea) which included treatment with acetaminophen (TYLENOL) every 4 hours on an unknown date. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
7 days after receiving dose 1 of the Moderna COVID-19 vaccine, the patient experienced swelling, hardness, and soreness at the site of injection. The patient self medicated with acetaminophen and diphenhydramine with no resolution. Patient to be evaluated by the emergency department.
Information has been received from a consumer concerning a patient who was vaccinated with the second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. The consumer reported that she "heard of a patient who died after the second MMR shot." No further information is available.
Complaining of hot face and chest also complaining of shortness of breath.  Lungs clear, temp 99, used cold cloth to face, feet elevated.  Left vaccination site at 6:00PM.
No PQC or additional AEs reported.; expired dose of MMR II was given today; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.       On 14-MAY-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) (0.5 mg, strength and anatomical location were not reported, lot # S013539, expiration date 02-MAY-2021) intramuscularly (IM) for prophylaxis (expired vaccine used). No additional adverse events were reported. The reported asked if patient should be revaccinated.
Temperature of 107 at home on 3-19-22 at 1:30 am Temperature of 105.5 in the ER on 3-20-22
High fever & local rxn; No allergies or past problems w/DTP; 5th shot; Diabetes in family
He had a TURP surgery 10 days after this vaccination. We didn?t make the association at the time but since hearing that this vaccine was put on hold because of blood clotting we thought we should report this. He had bleeding after the surgery along with massive blood clotting. He had to have a second emergency surgery that night because the clots were so severe and were causing problems with drainage from the bladder. Several days after he came home we had to rush him back to the doctor because blood clots again were blocking the drainage tube. He had to have his bladder flushed out and there were many blood clots. After that the clots seemed to clear up although some bleeding still persists.
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Severe, Systemic: Shakiness-Mild, Systemic: Vomiting-Medium, Systemic: Weakness-Mild, Additional Details: Patient stated prior to the vaccine that he was very nervous and did not like needles.  Less than 5 minutes after recieving the vaccine he stated he was not feeling well, I noticed that he had perspiration on his forehead. I gave him a small cup of water, he immediately vomited both the water and contents of his stomach. I gave him a bottle of water. He continued to sit near the pharmacy for roughly 45 minutes after which he stated he was feeling much better and left for home.
MENACTRA was used to reconstitute YF VAX vaccine and administered to a patient (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
impaired anti-pneumococcal polysaccharide antibody response; impaired anti-pneumococcal polysaccharide antibody response; Literature Report: This literature marketed report has been received from the authors of a published article, titled as above, and refers to a female adult patient with primary selective IgG subclass deficiencies (IgG1, IgG4). The patient's clinical presentation included bronchiectasis.  On an unknown date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX-23) (strength, dose, frequency, route of administration, indication, lot# and expiration date were not reported).  It was reported that pre and 4 weeks post-vaccination pneumococcal polysaccharide antibody titers were measured using multiplexed immunoassay (to remove cross-reactive antibodies).  On an unknown date, the patient had impaired anti-pneumococcal polysaccharide antibody response.  On an unknown date, the patient started treatment with intravenous immunoglobulin replacement therapy (IVIG), 800 mg/dL, but she was lost to follow-up after 4 months from starting immunoglobulin therapy. Nonetheless, during those 4 months, she had 2 episodes of infections requiring antibiotics.   The outcome of vaccine response impaired and antibody test negative was unknown.  The authors assessed the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX-23).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article (cross referenced with #1909USA012600).; Sender's Comments:  US-009507513-1909USA012600:
At 3am absolutely everything hurt with shooting pains; I had a fever and could barely move; I had a fever and could barely move; felt like my body started shutting down pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 14:15 (Lot number: FC3183) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reactive Airway Disease" (unspecified if ongoing); "Breastfeeding/4weeks Postpartum" (unspecified if ongoing); "Breastfeeding/4weeks Postpartum" (unspecified if ongoing); "In Jan2021, I was 14wks pregnant when I tested positive for Covid", start date: Jan2021 (unspecified if ongoing), notes: In Jan2021, I was 14wks pregnant when I tested positive for Covid; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: 1 month ago, I had postpartum endometritis which caused me to be hospitalized.; "I felt with the the uterus infection" (unspecified if ongoing), notes: no where near how I felt with the the uterus infection.; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: hospitalized for 3 days on heavy antibiotics.; "I had postpartum endometritis", start date: 2021, stop date: 2021, notes: Since the infection was resolved and I felt healthy and even started going back to the gym,. The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 21Aug2021 20:45, outcome "recovering", described as "felt like my body started shutting down pains"; PAIN (non-serious) with onset 22Aug2021 03:00, outcome "recovering", described as "At 3am absolutely everything hurt with shooting pains"; PYREXIA (non-serious), MOVEMENT DISORDER (non-serious) all with onset 22Aug2021 03:00, outcome "recovering" and all described as "I had a fever and could barely move". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, pyrexia, movement disorder. Therapeutic measures were taken as a result of pain. Additional information: Just over 6hrs after getting the first shot of vaccine patient felt like her body started shutting down. At 3am absolutely everything hurt with shooting pains. Patient had a fever and could barely move. At 4am I took Motrin. Patient did not receive other vaccine in four weeks. Patient receive Other medications in two weeks: Prenatal Vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Patient reported armpit swelling the night of the vaccine. Swelling accompanied soreness. But no injection site reactions. Swelling has decreased over 2 days.
I had running nose, serve headache, congestive, and sore throat that lasted for about 3 to 4 days. On Oct 12th, I tested positive for COVID-19. I contacted my doctor. They did an infusion therapy.
Chills, fever as high as 102.2 that night.  Tylenol brought down fever and stopped chills until it wore off, and chills a fever of 100.2 came back  during early morning. The next day (3/31) had fatigue, mild headache, general achiness, and fever stayed below 100.  On 4/1, symptoms have subsided.
He fell asleep on our way home from getting his vaccines when he woke up he acted tired and dizzy was having trouble sitting up by himself.. that soon faded but he still has slight trouble sitting up straight or walking straight. This morning he woke up crying and wouldn't eat anything so I looked in his mouth and he had white ulcers on his tongue. I immediately searched what vaccine could cause white ulcers in the mouth and it pulled up the Dtap shot he received yesterday.
Site of injection was swollen and red 3 days post exposure, site was size of 50 cent piece. Pt says had hard baseball size. She had aches and fever for 3 days. She treated with ice packs and acetaminophen.
Patient had swollen Lymph node of her  right arm pit (opposite of vaccinated arm).
no adverse event; a patient was administerd GARDASIL expired on 27-APR-2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 12-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # R027946, 0.5 milliliter for prophylaxis, which had expired on 27-APR-2021 (expired product administered) (dose, route and site of administration were not reported).  There was no adverse effect reported. No product quality complaint was involved.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This case was reported by a nurse and described the occurrence of injection site cellulitis in a 7 month old male who received Infanrix for prophylaxis. On an unspecified date in June 2003, the pt received the third injection of Infanrix (590B9) packaged in a prefilled syringe. The injection was made into the right thigh. The pt also received an injection of Comvax into the left thigh. On 6/18/03, "within a couple of days" post-immunization, the pt developed an injection site reaction on the right thigh. The pt was seen by the physician, who noted a 4-cm by 2.5-cm area of erythema and induration on the right thigh. The physician made a diagnosis of injection site cellulitis and prescribed Duricef. The event resolved on 6/25/03. The nurse considered the event to be serious (OMIC) because it jeopardized the pt or required intervention. The nurse considered the event was possibly related to vaccination with Infanrix.
Felt like I was going to catch the flu; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I was going to catch the flu) and PAIN (Body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I was going to catch the flu) and PAIN (Body aches). On 05-Feb-2021, INFLUENZA LIKE ILLNESS (Felt like I was going to catch the flu) and PAIN (Body aches) had resolved.            No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Additional information received and patient demographics were updated.
3/31/11 3:30 pm (24 hours post vaccine) patient experienced mild numbness and muscle weakness in (L) leg & arm. 4:00 pm took BENADRYL. 415 speech slightly slurred for a few minutes. Symptoms lasted 3-4 hours. Father is OB/GYN. He observed her at home. By the next morning symptoms gone. Child went to school. No other problems noted. Note symptoms on (L) side. Vaccine given (R) arm.
Red swollen area at the site of injection, approx 3 inches by 5 inches
His left armpit got big and swollen. He thinks it's  swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 29-years-old male patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0168, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 25May2021 at 09:15 as 1st dose, single for COVID-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. There was no history of previous immunization with the Pfizer vaccine that would be considered as suspect. The patient did not administered vaccine on same date of the Pfizer suspect. The patient did not receive any prior vaccinations (within 4 weeks). On 26May2021, evening 19:30-20:00, the patient experienced his left armpit got big and swollen, he thinks its swollen lymph nodes. Response was 6 over all safety summary, lymphadenopathy (0.3%). It had not gone down much. The patient stated that he had a little fact sheet which says it was a lymph node. He asked that was there any way that he could possibly get that to go down and how long it would last. He also asked for specific medication he could take for his swollen lymph nodes. The event did not require a visit to emergency room or physician office. There was no family medical history relevant to adverse event. The patient did not undergo relevant tests. The patient did not receive treatment for the event. The outcome of the event was unknown.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. In approximately 2015, reported as on multiple unspecified dates ranging from 15-OCT-2015 to 06-NOV-2015, the patients were vaccinated orally with improperly stored doses of ROTATEQ solution (lot# L008996, expiry date 01-DEC-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Left forearm with pain. Mother noticed 11/11/04 at morning time. Induration 80x55 mm arm circumference 260mm.
Typical anticipation of chills, fatigue, some mild body aches at 0300 on 02/02 but then developed swelling to face, hands, and feet with moderate to severe shortness of air at 12 p.m. that lasted an additional 24 hours.
pt recvd vax; 12oct94 red rash rt side of face; swelling face, ear, eye, rt side; no fever; no intense itching;