chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm; Feverish; swollen; Redness 4 Inch Diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), PYREXIA (Feverish), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (Redness 4 Inch Diameter) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (past medical history not provided).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm), PYREXIA (Feverish), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (Redness 4 Inch Diameter). At the time of the report, VACCINATION SITE WARMTH (Warm), PYREXIA (Feverish), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE ERYTHEMA (Redness 4 Inch Diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported
Hep A and Men B was given in left deltoid - patient c/o soreness and redness at site. It's also warm to the touch.
redness at injection site; itching at injection site; stomach pains; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site itching, stomach pain and upset stomach. The patient was treated with clobetasol propionate. Shingrix was discontinued. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the stomach pain and upset stomach were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, stomach pain and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and developed redness and itching at the injection site.  The redness at the injection site is approximately 6 inches in diameter. The patient already had a standing appointment with her physician and so she showed the physician the area on her arm during the appointment and the physician  advised the patient to use Clobetasol propionate on the site and advised patient to not get the 2nd dose.  The patient also experienced stomach pains and upset stomach following the administration of the vaccine. The patient did not consent to follow-up. Emergency room visit required. The patient did not provide any additional details. This case was linked with the case US2019149373, reported for patient's husband.
Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in spontaneous abortion.
Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Chills, swollen lymph nodes, redness/swelling/itching @ injection site Narrative:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: Gh9702) at the age of 59 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 14Apr2021 as dose 2, single (Lot number: ER8729), in left arm, on 08Dec2021 as dose 3 (booster), single (Lot number: Fj1620), in left arm and on 16May2022 as dose 4 (booster), single (Lot number: Fm9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic thoracic and cervical pain" (unspecified if ongoing); "Chronic thoracic and cervical pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Gabapentin caused leg cramps years ago., reaction(s): "leg cramps". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28Sep2023 to 02Oct2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300320790 same patient, different event/ drug;
Patient felt a lump which has gotten smaller over the last few days.  Today a week later the area is still red and slightly raised and warm to touch.
TDaP and PPSV 23 administered 1pm 12 hrs after excess fatigue, bedridden x 2wks. Mild HA myalgia, weakness, dizziness.
The patient was treated for shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for shingles. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
2 days after vaccine, left neck spasms and pain. Now developed sternoclavicular synovitis on the left side
PAIN IN LUMBAR AREA / SACRAL AREA; KNEE PAIN / PAIN TO HIPS; CHILLS; PAIN AT BOTTOM OF FEET; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 29 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, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on Left deltoid  for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced pain in lumbar area / sacral area. On 06-APR-2021, the subject experienced knee pain / pain to hips. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced pain at bottom of feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in lumbar area / sacral area, knee pain / pain to hips, chills, pain at bottom of feet, headache and fever was not reported. This report was non-serious.
Patient received FLUARIX ON 9/17/09 to left deltoid. Pt stated she started having pain to her left upper arm a few hours after vaccine administration. Pt continues to have pain to the left arm. Pt reported symptoms.
Began having H/A in back L region of my head within 48hrs. Began  smelling the same scent that I smelled when I actually had COVID 19 in Sept. within 4 days of receiving vaccine and 6 days later began having a "bleach" taste in my mouth which is the same taste I had when I had COVID19 by 1 week after vaccine the headaches were so severe and persistent (even though I was taking Tylenol and Motrin several times daily) that I spent all day in bed on day 8 and began having stomach pain and nausea (that may have been due to taking OTC NSAIDS for H/A's). Today is day 9, I remain bed resting I only have a dull headache with the use of Tylenol alone.
The day after injection I had a hard 2 inch, painful lump 2-3 inches under the injection site. This resolved in 2 days. One week after an itchy/painful rash started at this exact site. On the first day it was the same size and location the lump had been (again below injection site). Over the next 5 days it increased in size and eventually covered my upper arm up to the shoulder and nearly to the elbow, stretching under to the armpit at the top but not stretching all the way around closer towards the elbow. On day 6 of the rash the itching slowed and on day 7 it started to fade. Two coworkers had similar experiences but we don?t see these documented as an expected response anywhere.
This spontaneous report as received from a other health professional (Registered nurse) refers unspecified number of patients of unknown age. Current conditions and medical history was not provided. On an unknown date in 2014 (reported as since September 2014) the patients were vaccinated with (Merck) VARIVAX (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. Since September 2014, the patients were administered improperly stored (Merck) VARIVAX. No adverse effects were noted. Outcome and causality assessment was not reported. Product quality complaint was not reported. No additional information was reported. This is one of several reports received from the same reporter. Additional information has been requested.
have no energy; arm was swollen and felt like someone was burning her arm; chills; fever; nausea; headache; arm was sore; arm was swollen and felt like someone was burning her arm; severe diarrhea; joint pain; lightheaded, dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain) and ASTHENIA (have no energy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced DIZZINESS (lightheaded, dizzy), DIARRHOEA (severe diarrhea) and ARTHRALGIA (joint pain). On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore). 08-Apr-2021, the patient experienced CHILLS (chills). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheaded, dizzy), PERIPHERAL SWELLING (arm was swollen and felt like someone was burning her arm), DIARRHOEA (severe diarrhea), ARTHRALGIA (joint pain), ASTHENIA (have no energy), BURNING SENSATION (arm was swollen and felt like someone was burning her arm), CHILLS (chills), PYREXIA (fever), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Another concomitant included heart medicine.
Temperature of 100.1 F based on reading under tongue,  Sore Left Arm, Headache and weakness/groggy.
pt received vaccine in the left deltoid and next day had a hugh hematoma lateral aspect of the left hip, I am her primary care physicam I do not have details on the vaccine,
Blurred vision, scleral discoloration, inflammation localized, neck pain, generalized aching, pain in arm, pain in hip. Initial consumer report received on 14 November 2008 from a patient. A 71 year female received on 07 November 2008 FLUZONE (lot # not reported), intramuscular into the left deltoid. By the evening of the day of vaccination she developed swelling the size of an egg at the left deltoid area that was red. The back of the neck hurt and she experienced severe generalized body aches. In the morning (08 November 2008), she had blurred vision and her scleras were red and yellowed. She self treated herself with metal detoxification. By 13 November 2008 she was feeling better, but still had arm and hip pain. The patient had no illness at vaccination time, no prior adverse event to vaccination and no relevant medical conditions.
No adverse event; HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Apr-2023, 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. On 19-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP advised that his pharmacy administered a vaccine that was drawn up into syringe and was not used for 20hrs).    No concomitant medication details was reported. No treatment medication details was reported.  It was reported that syringe was drawn on 18-Apr-23 and used on 19-Apr-23.
This spontaneous report was received from a male consumer of unknown age referring himself. The patient's medical history and concurrent conditions were not provided. In approximately 2010 (also reported as "6 or 7 years ago") the patient stated that he was administered with a vial of ZOSTAVAX 1 dose, route of administration reported as "shot" (lot number, expiration date, concentration were unknown), which has a temperature stability excursion when he picked up it at his local pharmacy. It was also stated by the reporter that during the transportation from the pharmacy to his house, the vial experienced a room temperature environment, then the vial of ZOSTAVAX was placed inside of the patient's freezer at an unknown temperature, after that the vial was transported to the physician's office where the vial might have experienced a room temperature environment again. Information regarding concomitant medication was not provided. No adverse events were reported. Additional information has been requested.
6/8/21 -Presented with respiratory failure requiring intubation about 12 hours after 2nd dose of COVID-19 vaccine.  Desaturated to the low 80's despite oxygen.  Febrile to 38.8 after admission and had several breakthru seizures requiring loading doses of Keppra.   5/17/21-Had event of tachycardia into the 140s, and slight fever of 100.6, and 8 minute seizure after 1st dose.
Case number PHEH2015US020453, is an initial combined spontaneous report received from a pharmacist on 09 Oct 2015 with a follow up information received on 09 Oct 2015 with a follow up information received on 19 Oct 2015 with a follow up information received from the pharmacist on 09 Oct 2015. This report refers to a 64-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUCELVAX (batch number: 161211, expiry date: 01 May 2015) pre-filled syringe (PFS) at a dose of 0.5 ml intramuscularly on 02 Oct 2015. It was reported that the administered vaccine was expired. The case was reported non-serious. The reporter stated that the patient was doing well and no adverse events were reported following the maladministration. The patient would be re-vaccinated. No further information was provided. Follow up information received from the pharmacist on 09 Oct 2015: Updated expiry date and reporter's comment.
Inappropriate schedule of vaccine administered; This spontaneous report was received from a physician and lawyer referring to a adult female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.     Yearly from 2005 to 2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) or pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) (reported as pneumococcal vaccine) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). In September 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis.    The case was split from a legal case referring the same patient. ; Sender's Comments:  US-009507513-2207USA007086:
Initial unsolicited report received from non- healthcare professional on 15 February 2016. This case involves 4-year-old male patient who was vaccinated with fourth dose of IPOL (batch number- L1597-1, route of administration not reported) on left thigh, a fifth dose of Infanrix (manufacturer- GSK, batch number and route of administration not reported) on left thigh, a dose of Varicella (manufacturer- Merck, batch number and route of administration not reported) on right thigh, a dose of MMR (manufacturer- Merck, batch number and route of administration not reported) on right thigh on 12 February 2016. The patient's medical history and illness at time of vaccination was reported as none, pre-existing physician diagnosed allergies was reported as unknown. Previously the patient had received three doses of IPOL vaccine and four doses of Infanrix vaccine on an unspecified date. The patient's concomitant medications were not reported. On 12 February 2016, same day following the vaccination, the patient had experienced red, swollen, itchy and warm to touch area at injection site on left leg. Laboratory data and corrective treatment were not reported. The outcome of events was reported as not recovered. List of documents held by sender: none.
mom said temp went to 104 could not get temp down; adm to hosp; MD said pt had too many immun @ one time; also mom said MD stated had ear infection; t102 x 2 days;
Received phone call from pt. advising got her flu shot yesterday afternoon. Then midnight itched, feeling bad. Then this morning been throwing up and have a severed headache. Advised her to see her private provider for evaluation. Also arm is sore.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 (Lot number: FF2593) at the age of 61 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Major depression" (unspecified if ongoing), notes: Verbatim: Clinical depression. Concomitant medication(s) included: MARPLAN [LEVONORGESTREL] taken for major depression. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunization, reaction(s): "Slight headache"; Bnt162b2 (dose 2), for COVID-19 Immunization, reaction(s): "Slight headache". The following information was reported: MUSCLE SPASMS (non-serious) with onset Nov2021, outcome "not recovered", described as "severe cramping in my thigh"; CHILLBLAINS (non-serious) with onset Nov2021, outcome "not recovered", described as "chilblains"; ERYTHEMA (non-serious) with onset Nov2021, outcome "not recovered", described as "they were red"; INSOMNIA (non-serious), PAIN (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I could not really sleep, it hurts so bad". The events "severe cramping in my thigh", "chilblains" and "they were red" were evaluated at the physician office visit. Additional information: Reporter stated that "I actually had two, the one was relatively minor just like from the, I had a booster shot and that was the one that was causing me the issues but the other two (Pfizer COVID-19 Vaccine) I just had a slight headache which was nothing compares to my report but the booster shot I had November 5th and that night I had a severe cramping in my thigh. I do not wanna exactly say it was a cramp but it was like I could not really sleep, it hurts so bad, I had to keep turning different ways and it just kept hurting but the biggest thing that it happened from that same booster shot was not until couple weeks after and I got the chilblains." "I saw a Podiatrist because I had the chilblains developed on my feet, on my toes and he is the one that let me know what they were, because I just thought I was having sore feet from exercising (Further not clarified) and but they were red and they were really tough, they were like numb and causing me a lot of, they were not numb (Further not clarified) they were causing me pain but so, Its chilblains and when I saw him the next time he confirmed that, he said there are all about the same but they are not (Further not clarified)." No follow-up attempts are possible. No further information is expected.
On day 7 arm where injection was given started itching and have a red rash around injection site.
This spontaneous report was received from a nurse prescriber via a company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 injection (exact dose; lot number, expiration date and route of administration were not reported). The reporter stated that the patient returned for the second dose in the vaccination schedule and on an unknown date in 2017, was vaccinated with an expired dose of GARDASIL injection (expiration date: February 2017; exact dose; lot number and route of administration were not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.