chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; she felt her muscle into the eyes were very heavy to close, she had droopy eyes, having eye issues; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ASTHENOPIA (she felt her muscle into the eyes were very heavy to close, she had droopy eyes,) and OCULAR DISCOMFORT (having eye issues) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine in October 2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ASTHENOPIA (she felt her muscle into the eyes were very heavy to close, she had droopy eyes,) and OCULAR DISCOMFORT (having eye issues). In November 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), ASTHENOPIA (she felt her muscle into the eyes were very heavy to close, she had droopy eyes,) and OCULAR DISCOMFORT (having eye issues) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported as unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient received all the COVID-19 shots and patient visited 4 doctors and 1 neurologist but they told  there is nothing wrong with it and they could not explain if this was caused by the vaccine. No treatment medications were reported.
This report of itchy rash is being submitted in an expedited time frame as requested by the FDA. Information regarding Flumist nasal solution was received from a parent regarding her 4 year old son who received a dose on 12/12/03 and developed an itchy rash. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on 12/12/03. Dose regimen was 1 dose 1 time per day (IN). Concomitant medications were not reported. On 12/15/03, the patient, a 4 year old (medication error), developed an itchy rash from neck down to extremities (rash) described as itchy (pruritus). He was treated with Benadryl and the rash disappeared in 6 days. On 1/6/04, the same rash broke out and he was again given Benadryl. No additional information was available at the time of this report. (OMIC)
3 months old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3KF4F, expiry date 22nd March 2024) for an unknown indication.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th September 2022, 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 Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which inappropriate age at vaccine administration.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 26-APR-2017, the patients were vaccinated with an expired dose of PNEUMOVAX 23 (lot # L019836, expiry date: 24-MAR-2017, dose, strength, vaccination site unspecified) for prophylaxis. There were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 27-DEC-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice. ; Sender's Comments:  US-009507513-2304USA002221:
extreme fatigue; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "extreme fatigue"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful at time of injection nauseous headache up shivering all night feel like I have a fever feel like I might have diarrhea general feeling of the bad flu.
Fever to 104.5 degrees F. Seen at hospital. Motrin 25mm PO
Dose 1 - 1/21/21 - I had a fever around 102 and felt the sickest I've ever been. It was like a raging pain on my body, nauseous but couldn't throw up and just very uncomfortable. I had pain all over. I was taking Tylenol, but my temperature kept increasing and I couldn't get it down. I was shaking with chills and couldn't stop myself. I was also sweating, cold and just really, really sick. I called my doctor the same night and was told to keep myself hydrated. I was violently ill for about 4 or 5 hours and the low-grade temp lasted until the next day. My digestive system was messed up for about a week and a half or so, and then everything went back to normal.  Dose 2 - 2/18/21 - I got it around the same time. I took Ibuprofen around 1:30pm, another 800mg around 6:30pm and then I took Tylenol around 11pm because I started experiencing shaking, chills, my fever got up to 104 and I was having waking terrors. I had delusions where I felt like everything was being taken out of my body and put back in. I felt so badly that I was moaning and couldn't tell what was real. I felt like I needed to go to the ER, but didn't have the strength. The episode lasted for about 5 hours and started to break around 5am. I had a 99.5 temp the next day, so I was still taking Ibuprofen and Tylenol. Around mid-day, I started to feel better, but continued to feel unwell until the following day. I was still taking Ibuprofen around 3pm that Sunday, but started to feel better afterwards. I continued to have stomach issues for about a week, just like the first dose.
bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; bruise on the hand side tip of her finger and it is tingling and hurting; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I have had a couple of injuries on that side of my body and the all seem to be inflamed; I had a shoulder injury which is not sore and hurting on that side; tendon and had nerve damage; pain and sore in the injury to my shoulder and my hand; pain and sore in the injury to my shoulder and my hand; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history included arthritis on an unknown date unknown if ongoing. The concomitant medications were not reported. On an unspecified date, after first dose of vaccine, all of sudden the last day or two the patient experienced bruise on the hand side tip of her finger and it is tingling and hurting, she have had a couple of injuries on that side of my body and the all seem to be inflamed, she had a shoulder injury which is not sore and hurting, the injury she had to her hand and arm was a cat bite that went through the tendon and had nerve damage to that area It has since healed pretty well but it feels like it may be inflamed and I haven't reinjured it, pain and sore in the injury to her shoulder and her hand was nothing severe but she was just surprised to wake up and have the pain and a bruised mark on the pad of that fingertip and it was tingling and hurting, pain in this arm was little sore. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient woke up at midnight 1/15/21 (12 hours after receiving vaccine)  with high fever of 104, chills, fatigue, nausea, dry heaves and severe headache.  At 6am, fever down to 101.2 with the  use of Tylenol.  Other symptoms remained.  Wretching  ceased at 9 am.  Still has fever and headache.
Information has been received from a pharmacist refers to a 72 year old female patient without medical history or drug reactions/allergies. The patient had received a dose of FLUZONE HD injection on unspecified date in September 2014 and did not have "any problems" after receiving the flu shot. On 07-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K020801, expiration date: 31-JAN-2016, dose unknown) subcutaneous. Concomitant therapies included calcium with vitamin D, benazepril hydrochloride, amlodipine, desmopressin and NEXIUM. On 08-MAR-2015 the patient developed itchiness, warmth to touch, erythema and swelling "about the size of golf ball" at the injection site after receiving ZOSTAVAX. The patient applied ice to the injection site on 10-MAR-2015. The patient went into pharmacy and spoke with the pharmacist on 11-MAR-2015. No lab was performed. The outcome of the events was reported as recovering. Causality was not provided. Additional information has been requested.
DTaP given 3/24/03-mom noticed Rt arm red/swollen 10x11cm 3/26/03. Benadryl/Tylenol/cool compress.
flu; swollen lymph node; headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "unknown", described as "sore arm"; INFLUENZA (non-serious) with onset 13Mar2021, outcome "unknown", described as "flu"; LYMPHADENOPATHY (non-serious) with onset 13Mar2021, outcome "unknown", described as "swollen lymph node"; HEADACHE (non-serious) with onset 13Mar2021, outcome "unknown", described as "headache".  Additional information: Reporter stated that she had her first Pfizer Covid vaccine shot last Thursday (11Mar2021) and experienced some side effects. Thursday-Friday she had a sore arm, Saturday she experienced flu, swollen lymph node and headache. Asking if she is contagious with these side effects as would want to go out tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left upper arm with large red area, hard and warm to touch. Given 5/31/2005. Reaction 6/2/2005. Placed on Clindamycin for 10 days.
Bunch of people in his company that got that round of vaccines ended up getting Covid anyway; 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 COVID-19 (Bunch of people in his company that got that round of vaccines ended up getting Covid anyway) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Bunch of people in his company that got that round of vaccines ended up getting Covid anyway). At the time of the report, COVID-19 (Bunch of people in his company that got that round of vaccines ended up getting Covid anyway) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment information was not provided.
Localized swelling and edema at site that continued with further swelling, weeping a little at site. Quarter-size area of weeping and vesicle on rt. shoulder, erythema that travels down toward elbow and up to shoulder joint. Cellulitis (see notes)
Hives on neck, spread to face, eyes,  1/25/2013 gave Benadryl around 7 PM, before kicked in couldn't breathe, took 3-4 more times before hives stopped coming back.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: pain/bubble under armpit of left arm-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: Patient is reporting pain, tenderness, and raised bubble type reaction under armpit of left arm that began 1 day after injection.  There is also a tennis ball sized swollen area on side of chest close to armpit area that began 2 days after injection.  Patient notified his PCP and will monitor for development or resolution of symptoms.
After 2nd shot of Moderna (which was on 4/27/21), within 48 hours, I experience a red circular patch below the 2nd injection site. Sought medical treatment with my PCP who prescribed me an antibiotic. Believe this was directly related to the 2nd injection, but found it odd that it was not at the actual injection site. It was more on the 1st injection site. The red circle/patch is hot to the touch and sends a burning sensation down my arm.
pt recv vax & 2-3hr post vax pt exp erythema @ the inj site (about the size of a quarter);6/6/98 the redness was about 8 inches in diameter;the reporting MD noted DPH & given & pt sx resolved w/in 24hr;
Pt was seen at ER ( per discharge summary) on 5/27/2019 wtih "red targetoid rash consistent with erythema multiforme. The rash is likely to be a reaction to his vaccines on 5/22". ER Attending at time of visit- Dr.
NO ISSUES AT TIME OF SHOT( 9am), WAITED 15 MINUTES THEN TRAVELED  25MILES. AT 12PM  NAUSEA, HEADACHE, VOMIT. TOOK 2 OTC PAIN MED. NAPPED. AT 3PM, MUSCLE PAIN, HEADACHE. AT 7 PM BODY FEELING SOMEWHAT BETTER BUT STILL GOT HEADACHE.
Very dizzy, similar to vertigo symptoms (per patient description) x 3 wks after.
Described by wife: Sores on the left wrist and forearm  starting on 3/27/21 that "still itch" and mouth sores. Wife reports that she is treating the sores with her zovirax topically applied to the sores on the arm.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pruritus. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pruritus. On an unknown date, the outcome of the fever and pruritus were recovered/resolved. It was unknown if the reporter considered the fever and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not have lot number or expiration date of the vaccine. The pharmacist reported that the vaccine was given at another facility. The pharmacist did not have exact details as to when events began or ended.
Chills and muscle aches and bone pain , unable to climb stairs, fatigue and tiredness. Improved after 24-48 hours.
swollen arm; swollen arm and a painful itchy blistering rash/ diagnosed with shingles; other dermatological injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after injection, the patient suffered a swollen arm and a painful itchy blistering rash. As a result of her symptoms, she presented to a medical provider and was diagnosed with shingles, as well as, other dermatological injuries. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live(ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Shingles and other dermatological injuries were considered to be disabling.  Additional information has been requested.
Headache, Arthralgia & NauseaVomiting Narrative: Received vaccine
The mother informed us today when the child came in for additional vaccines to the public health department, that back in 2012, the child had a fever for 6 days after his set of shots. He had a prior history of febrile seizures, but did not have a febrile seizure during the 6 days of fever post-vaccine. Mom states that she informed the child's primary care provider.
Injection day (headache and tiredness). Since then, headache; injection site soreness; random itching (behind ears, head, shoulders, upper back, legs, arms - not constant nor all of the time no redness nor rash) - taking Tylenol for headache and Benadryl and Aveeno shower gel for itching.
Case number PHEH2013US023518 is an initial spontaneous report received from a pharmacist on 07 NOV 2013 with follow-up received on 13 DEC 2013. This report refers to a 40-year-old female patient. Her medical history and concomitant medication ws not reported. The previous vaccinations were well tolerated. She was vaccinated with 0.5 ml dose of FLUVIRIN 2013/2014 (batch number 13392P) intramuscularly on 03 OCT 2013 and experienced bursitis on the arm the day after her flu shot. The affected arm was the same arm that had the site of injection and the pain continued at the time of reporting. On 06 OCT 2013, she experienced pain in upper arm and was unable to lift the arm. She was treated with prednisone, Benadryl and heat patches. Final outcome of the events was recovered. No further information about seriousness and causality was available.  Follow-up received on 13 DEC 2013: New events (vaccination site pain and injected limb mobility decreased) and vaccination dose was updated.
SLIGHT CALF CRAMPING; SEVERE HEADACHE; BRUISE AT THE INJECTION SITE; FEELING HOT AND COLD; BODY HURT/BODY ACHEY; ARM SORENESS AT INJECTION SITE; NAUSEA; DIZZINESS; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced couldn't sleep. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced body hurt/body achey. On 08-APR-2021, the subject experienced arm soreness at injection site. On 09-APR-2021, the subject experienced feeling hot and cold. On 10-APR-2021, the subject experienced bruise at the injection site. On 11-APR-2021, the subject experienced severe headache. On 20-APR-2021, the subject experienced slight calf cramping. On 21-APR-2021, Laboratory data included: CBC (NR: not provided) Normal, and CT scan (NR: not provided) CLEAR. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sleep, and arm soreness at injection site on 10-APR-2021, and body hurt/body achey on 09-APR-2021, was recovering from nausea, dizziness, feeling hot and cold, and bruise at the injection site, and had not recovered from severe headache, and slight calf cramping. This report was non-serious.