chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injury to finger nos in a 45-year-old female patient who received MENVEO (batch number: M14133, expiry date April 2016). This case was vaccinated with a product complaint. On an unknown date, the patient received MENVEO. On an unknown date, immediately after receiving MENVEO, the patient experienced injury to finger nos, pharmaceutical product complaint and inadvertent exposure to vaccine. On an unknown date, the outcome of the injury to finger nos was recovered/resolved and the outcome of the pharmaceutical product complaint and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the injury to finger nos to be related to MENVEO. Additional details were received as follows: Nurse reported that there were broken or cracked MENVEO vials (1 liquid conjugate, 1 powder conjugate vial from same box). It was confirmed that MENVEO was not administered to any patient. When the reporter reached in the box of MENVEO with her right hand, she poked the tip of her finger. This also led to an inadvertent expose to vaccine. This issue occurred sometime between 16th JULY 2015 and 25th AUGUST 2015. However, specified date was unknown. She stated that their local representative might have reported this to GlaxoSmithKline in the past but she was unable to fully confirm and was unable to locate previous record. It was reported regarding deft that unknown at what point or step defect was discovered. The package conditions was not damaged or open. It was unknown who opened the box. Staff who were administering the vaccine in the office were all experienced users of MENVEO. No damage to carton or evidence of leakage inside of carton was found. Glass pieces remain the carton. Product was stored refrigerated. Breakage was specified to neck of vials, underneath the bottom of the grey stoppers. Both vials were available for return. The health care provider who had direct account with GSK, submitted the credit template. Filing related adverse event with Global Clinical Safety and Pharmacoviligiance because of injury experienced by the reporter due to cracked vials. When the reporter reached into the box of MENVEO with her right hand, she poked the tip of her finger. She was unable to recall further specifics of the incident since it occurred a while ago. No residual effects were noted from the injury.
Started having confusion at 3#0 a.m. Sunday morning. Unstable gait and hypoxia at home. More congested than usual. Had 2nd COVID vaccine 4 weeks ago. Had visual  hallucinations with seeing "bugs" Admitted with positive COVID  and Influenza B  diagnosis.
MMR given SQ in Lt leg. Mom noticed within 5 mins red lump at site. Noted red lump 2 inches diameter. Ice pk applied to site. NO other s/s. 7:10pm no increase in size. No x/o.
Initial report was received from a physician on 29 October 2009. A 76-year-old male patient received an intramuscular injection of FLUZONE SV 2009-2010 (lot number U3193AA) on 16 September 2009, and two days post-vaccination experienced suspected influenza. He was subsequently diagnosed with Guillain Barre Syndrome. Medical history included benign prostatic hypertrophy with elevated PSA, and the patient was taking FLOMAX, baby aspirin, FIBERCON, and ZYRTEC concomitantly. He had not received any other vaccines within four weeks of vaccination with FLUZONE, and was not ill at the time of vaccination. The patient received influenza vaccine annually, with no reported adverse events with previous vaccinations. On 18 September 2009, two days post-vaccination, the patient presented to his physician with complaints of chills/rigors, sweats, minimal cough, and sore throat. Testing for influenza was negative, however his physician suspected flu and so the patient was treated with TAMIFLU. On 06 October 2009, 20 days post-vaccination, he presented to the emergency room and was subsequently diagnosed with Guillain Barre Syndrome. He was discharged on 12 October 2009 and at the time of the report was undergoing physical therapy. The event was considered to be ongoing. Documents held by sender: None. 11/13/09 DC summary received for dates 10/6/09 to 10/12/09. Medical records received as well. DX: Probably GBS, neutropenia, benign tumor. Presented with weakness in all extremities. Dysphagia,  Viral syndrome prior to sx. Pt. tx with IVIG x5 days with improvement. Assessment: weakness noted. DC home in stable condition.   11/12/09, 12/18/09 Hospital records and discharge summary received. Service date 10/60/09. Assessment: Guillain-Barre Syndrome. Patient had influenza 1 week prior to admission followed by progressive central weakness. Unable to get off toilet. Proximal muscle strength deficit. Admitted to ICU. Transfer to higher level institution.   12/18/09, 12/22/09 Additional hospital records and discharge summary received. Service dates 10/6/09 to 10/12/09. Assessment: Probable Guillain-Barre Syndrome, neutropenia, benign tremor.  Flu-like symptoms followed by progressive weakness. Transferred from another facility. Was unable to walk, stand, activities of daily living impaired. Perioral paresthesias, metallic taste. Weakness extremities. IVIG administration. Headache.
Constant shoulder pain left arm, chest pain, constant headache, memory loss, unusual pain all over my body, sleep loss, intramuscular pain.
On 10-28-2015, around 3PM, feet were itching - also arm pits - body covered in rash. Called the nurse hotline. My Dr. was on call - he informed the nurse to tell me to take CLARITIN and PEPCID. Come in Monday, if still broken out. Rash went away, but reoccurred on Tues (11-3) But very light - continued CLARITIN and PEPCID - still breaking out today (11-6).
High fever ~ 104F lasting for more than three days. Blood count came back normal, ears and lungs looked fine the following day from the onset of the fever. Still not recovered on the 4th day of the fever.
Swelling and pain in the Shoulder join. Injection site looks fine. Took Tylenol, applied ice and then heat because ice wasn't making it feel better. Hurt so bad she went to the ER where they gave her Benadryl, Prednisone, and Norco 5/325mg. Husband brought in RXs later that day for Prednisone and Norco 5/325mg.
Severe headache, severe itching, fever, swelling of the face, redness of face and legs, arm very painful next day.  Lethargic, awake all night with symptoms
A report was received from a health care professional on 12/17/02 concerning a 32 year old female vaccinee who experienced serum sickness one day after receiving Fluvirin on 11/15/02. It was reported that the vaccinee had received an influenza vaccine for the past five years with the date of last vaccination reported as 2001. Concomitant medication reported included unspecified birth control pills. On the 11/16/02 the vaccinee developed hives and was treated with methylpredinisolone for seven days with improvement. After treatment with methylprednisolone was complete on approximately 11/23/02 the hives returned and the vaccinee was treated with prednisone (dose unk). On 12/6/02 the vaccinee began to experience swelling in the ankles, knees and shoulders and experienced a fever (temp unk). On 12/6/02 the vaccinee was hospitalized where the attending physician diagnosed serum sickness. The vaccinee was treated with unspecified IV steroids, methylprednisolone and ciprofloscin for five days. The vaccinee was discharged from hospital on 12/8/02. It was reported that the symptoms had improved but had not resolved. The reporter has assessed the relationship of the vaccine to the event as probable.   Follow up on 02/27/2003: "A report was received from a health care professional which stated that the vaccinee had also experienced wrist swelling and had a fever of 101C approximately 2 weeks following vaccination.  The vaccinee had recovered at the time of the report."
muscle / pain; joint pain; headache; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received Shingrix. On 5th October 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, joint pain and headache. On an unknown date, the outcome of the muscle pain and joint pain were not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the muscle pain, joint pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Shingrix 1 week before reporting since then, she had muscle and joint pain, that had not resolved. The patient initially had  headache but it was resolved. The reporter did not consent to follow up.
Vaccine was given more than 30 days from storage and was expired; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was given more than 30 days from storage and was expired) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was given more than 30 days from storage and was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was given more than 30 days from storage and was expired) outcome was unknown. Not Provided      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  Vaccine was placed in refrigerator on 21-Sep-2021, Vaccine had not undergone any temperature excursion and no Adverse events were noted.   This case was linked to MOD-2022-491837 (Patient Link).
Information has been received from a registered nurse (R.N.) concerning an approximately 24 year old female who in 2006 was vaccinated with her second dose of GARDASIL (Lot number unknown) and on 09-AUG-2010 was vaccinated with her third dose of GARDASIL (Lot number unknown). The patient was also having a colposcopy for an abnormal PAP test. The abnormal PAP test revealed high risk HPV. The patient sought medical attention in the office. At the time of the report, the patient had not recovered from abnormal PAP test and high risk HPV. Follow-up information has been received from a registered nurse who indicated that the patient did not receive her 3rd dose of GARDASIL on 09-AUG-2010. Additional information is not expected.
rash on her side/rash on her trunk area on both sides/erupting on her trunk/little breakouts; itching / is still experiencing come itching/itchy; Bumps; This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced rash, pruritus and rash papular. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the rash and rash papular were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the rash, pruritus and rash papular to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the vaccine in her left arm and developed a rash on her trunk area on both sides.  It was currently erupting on her trunk and started 3-4 weeks ago and was itchy and it had bumps.  The physician provided 10 day Anti-Viral medication. Itching was not resolved and patient notified physician again on 10th August 2020 and wanted to know if this was common after receiving the Shingrix vaccine. She had completed the antiviral but still had little breakouts at the time of reporting. The reporter consented to follow up.
Patient received vaccine 11/5/21 and was admitted to the hospital 11/7/21 for an acute right cerebellar infarct
50mm red area around injection site. Pt denies any other symptoms. Pt instructed to apply warm compresses and observe for any changes.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-FEB-2015 the patient was vaccinated with expired ZOSTAVAX (dose and route of administration were not provided; lot # H021459 with expiration date: 30-APR-2014). No adverse effects were noted. Additional information has been requested.
really bad GERD reflux; hands got itchy on the fingers and palm; felt achy; felt real tired (fatigue); arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (hands got itchy on the fingers and palm), GASTROOESOPHAGEAL REFLUX DISEASE (really bad GERD reflux), MYALGIA (felt achy), FATIGUE (felt real tired (fatigue)) and VACCINATION SITE PAIN (arm sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD (normally takes Peptidase, chews Tums and Pepto-Bismol for her GERD Reflux). Concomitant products included PEPTIDASE, CALCIUM CARBONATE (TUMS 500 CALCIUM) and BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for GERD, LISINOPRIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (felt achy), FATIGUE (felt real tired (fatigue)) and VACCINATION SITE PAIN (arm sore). On 30-Jan-2021, the patient experienced PRURITUS (hands got itchy on the fingers and palm). On 01-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (really bad GERD reflux). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 28-Jan-2021 for Vaccination site pain, Myalgia and Fatigue, at a dose of 1 dosage form and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) on 01-Feb-2021 for Esophageal reflux aggravated, at a dose of UNK dosage form. On 30-Jan-2021, MYALGIA (felt achy), FATIGUE (felt real tired (fatigue)) and VACCINATION SITE PAIN (arm sore) had resolved. On 01-Feb-2021, PRURITUS (hands got itchy on the fingers and palm) and GASTROOESOPHAGEAL REFLUX DISEASE (really bad GERD reflux) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a Registered Nurse concerning a 62 year old female patient with gastrooesophageal reflux disease, diabetes and hypersensitivity to cyclobenzaprine hydrochloride and LEXAPRO. She had a history of herpes zoster who on 11-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 655501/1035F). It was not clear if this was the first vaccination for the patient. Concomitant therapy included zoster vaccine live (Oka/Merck) (MSD), metoprolol, ezetimibe (+) simvastatin (MSD), RESTORIL, BYETTA, ASPIRINE and DETROL LA. It was reported that the patient received the pneumococcal 23v polysaccharide vaccine and developed rash at the injection site and low grade fever. The time development of the rash was unclear, but the patient was seen in the office for the rash the next day on 18-APR-2008. Her symptoms were described as chills and low grade temperature of 99.5 F. The rash at the injection site was described as pink, tender area 17X10 centimeter in diameter, hot to touch, described as a diffuse erythroderma. The right upper arm injection site elbow was involved and the whole arm was swollen. The patient was prescribed KELFEX 500 mg twice a daily for three days. The last contact with the patient was on 18-APR-2008. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The outcome was unknown. Additional information is not available.
I had a stage 1b malignant melanoma lesion removed from my right shoulder in 2014 and had completed all required follow-up. About a week after receiving the first dose (left arm), I noticed a small marble-sized lump in my right armpit. The lump continued to grow rapidly and I went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. I received the second dose on 18 February (left arm) and noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well. The melanoma is limited to my right armpit. We are reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because the National Institutes of Health is investigating the biopsy/pathology of the tumor in the right axilla as there are features they have never seen before in melanoma.
woke up in the middle of the night with a fever of 100.2 degrees F and muscle soreness took Tylenol 500mg at 5am then at 8am fever and muscle sorenessbeginning to come back around 5pm
rash; congestion; nausea; Chills; Headache; Face swollen from cheeks up; Eyes swollen; Hard time lifting arm; Chills; severe headache; Fatigue; Injection site achiness; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion), EYE SWELLING (Eyes swollen), LIMB DISCOMFORT (Hard time lifting arm), SWELLING FACE (Face swollen from cheeks up) and RASH (rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced LIMB DISCOMFORT (Hard time lifting arm), the first episode of CHILLS (Chills), HEADACHE (severe headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Injection site achiness). On 25-Apr-2021, the patient experienced EYE SWELLING (Eyes swollen). On 26-Apr-2021, the patient experienced SWELLING FACE (Face swollen from cheeks up). On 28-Apr-2021, the patient experienced NASAL CONGESTION (congestion), NAUSEA (nausea), the second episode of CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced RASH (rash). At the time of the report, NASAL CONGESTION (congestion), EYE SWELLING (Eyes swollen), LIMB DISCOMFORT (Hard time lifting arm), SWELLING FACE (Face swollen from cheeks up), RASH (rash), HEADACHE (severe headache), FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site achiness), NAUSEA (nausea), the last episode of CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            This case was linked to MOD-2021-090312 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Aches/Pains; Malaise; Headache; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  An elderly male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "Aches/Pains"; MALAISE (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered". It was unknown if therapeutic measures were taken as a result of pain, malaise, headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
my right arm is it is just it is swelling at injection site; arm swelled up and turn purple; my right arm is it is just it is swelling at injection site; arm swelled up and turn purple; my right arm is it is just it is swelling at injection site; arm swelled up and turn purple; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2) (Lot number: 070H21H) as dose 1, single for covid-19 immunisation. Relevant medical history included: "infected and had a severe lung problem" (unspecified if ongoing); "two type of pneumonia" (unspecified if ongoing); "lung surgery right before COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), PERIPHERAL SWELLING (non-serious), SKIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "my right arm is it is just it is swelling at injection site; arm swelled up and turn purple".  Additional Information: It was reported that the patient was concern about what happened after she had her booster shot and her son first shot. They thought they had the same thing that happened with little bit odd on both of them. It was also due to the fact that she had the lung surgery right before COVID, and she meant, she had been in a breakout and had her surgery and lung was constantly spasm, the further clarification was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200036095 Same patient and drug, different event separated in time;US-PFIZER INC-202200036495 Same reporter, same drug, different patient
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 03-JUL-2017 the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(V120), (route not specified) (lot # M046140, expiration date 27-SEP-2019) for prophylaxis; that was found to be improperly stored. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit. Time frame: 20 minutes. No previous temperature excursion. Identified by data logger. No adverse event was reported. No further information to report. Additional information is not expected.
Dose 1: 2/23/2021 Dose 2: 03/16/2021