chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; pain at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash), INJECTION SITE PAIN (pain at injection site) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Tylenol                                                        Twice a day for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection site) and FATIGUE (fatigue). On 29-Jan-2021, the patient experienced RASH (rash). On 28-Jan-2021, INJECTION SITE PAIN (pain at injection site) and FATIGUE (fatigue) had resolved. At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Self Administered: Tylenol QD for pain in addition to daily medication   Reporter did not allow further contact
Chest pains that come and go, my feet and hands itching, migraine, chills, nausea, rash
MD indicates 2 pts have experienced 2 instances of urticaria post Engerix-B;
Mass fatigue 6 hrs post vaccine; Vomit 4.50 hours post vaccine; Nausea 3 hours post vaccine/ nausea lasted all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 09:30 (Lot number: EW0177) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CENTRUM VITAMINTS. Vaccination history included: Bnt162b2 (Lot number: ER8736, Administration time: 11:15 AM, Vaccine location: Left arm, Dose number: 1), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 17May2021 12:30, outcome "recovered" (May2021), described as "Nausea 3 hours post vaccine/ nausea lasted all day"; VOMITING (non-serious) with onset 17May2021 14:20, outcome "recovered" (May2021), described as "Vomit 4.50 hours post vaccine"; FATIGUE (non-serious) with onset 17May2021 15:30, outcome "recovered" (May2021), described as "Mass fatigue 6 hrs post vaccine". Therapeutic measures were not taken as a result of nausea, vomiting, fatigue.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not received any other vaccines within 4 weeks prior to Covid vaccine. Reported Event: nausea 3 hours post vaccine. vomit 4.50 hours post vaccine. mass fatigue 6 hrs post vaccine. nausea lasted all day.Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination the patient was not tested for Covi-19. Patient did not had allergies. Device Date: 19May2021.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA009918:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
Fever, weakness, body aching, vomiting and diarrhea for 4 days, started 1 week post injection #2. Reported to nurse on 8/11/03.
Injection site faint redness approx 1" X 2" with mild itching.
Developed pink / red cutaneous Rash that grew in size to large 3? x 5? lesions. Several spots all over both legs and one in right arm.  First diagnosed as vasculitis Dermatologist says it may be psoriasis now. Pathology pending.  Been prescribed Clobetasol and Opzelura topical.
Left arm started to itching; A red spot the size of a silver dollar and it was 4 inches below the injection site;  This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Left arm started to itching) and INJECTION SITE ERYTHEMA (A red spot the size of a silver dollar and it was 4 inches below the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Left arm started to itching) and INJECTION SITE ERYTHEMA (A red spot the size of a silver dollar and it was 4 inches below the injection site). At the time of the report, PRURITUS (Left arm started to itching) had not resolved and INJECTION SITE ERYTHEMA (A red spot the size of a silver dollar and it was 4 inches below the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.
Reinfection on day 14, with positive test; Reinfection on day 14, with positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EI9293), in left arm, on 03Feb2021 as dose 2, single (Lot number: EI9266), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZOLOFT; AMLODIPINE; PRAVASTATIN. Past drug history included: Compazine, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Apr2022 at 19:00, outcome "unknown" and all described as "Reinfection on day 14, with positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Apr2022) unknown; (17Apr2022) Negative; (24Apr2022) positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that, the patient received Paxlovid drug for the treatment of COVID-19 from 11Apr2022 to 16Apr2022.  Follow-Up (29Apr2022): Follow-up attempts are completed. No further information is expected.
TM 101 at 50 + hrs after injection with Erythema multiform (minor) rash primarily within 6 inches from injection sites - anterior thighs & few lesions left abd.
not feel well; soreness at injection site; Heart Palpitations; Uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 6th September 2018, refer case US2019GSK074706).   On 5th February 2019, the patient received the 2nd dose of Shingrix. On 5th February 2019, 2 hrs after receiving Shingrix, the patient experienced feeling unwell. In February 2019, the patient experienced injection site pain, palpitation and discomfort. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, palpitation and discomfort were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the injection site pain, discomfort and feeling unwell to be related to Shingrix. The reporter considered the palpitation to be related to Shingrix.  Additional details were provided as follows: Approximately two hours after receiving Shingrix vaccine she reported that she started to not feel well and took Advil. This did not last very long.  She also, again, experienced soreness at the injection site that lasted for a couple of days.  Two days after receiving the 2nd dose she started to have heart palpitations. She went to her physician on 13th February 2019 and was given a heart monitor that she wore until 17th February 2019. It was noted that she was having occasional heart palpitations. She was still having these palpitations and she described them as being uncomfortable. She felt that the heart palpitations are related to the product.  The reporter consented to follow up.
Arm became swollen (bicep) 1-2 days after injection. Pt. contacted MD and was told to get to OTC BENADRYL treatment. Spoke w/ pt. 10-1-2012 he had recovered. Arm was red/discolored/inflamed. Pt. had sweats/fever. Inj. 9-24-12. Treatment 9-26-2012.
Large red swollen area on left arm (site of injection) warm and tender extended to below elbow. Patient also reported fever and chills and sweats.
About 8-9 hours after injection body aches began followed by fever and chills. Around 48 hours post injection severe acid reflux and vomiting began followed by diarrhea. Vomiting/diarrhea  lasting about 24 hours, reflux lasting 72+
Information has been received from female physician who was "recently" exposed to a patient who was vaccinated with a dose a Zostavax and developed shingles on 25-JAN-2007. On 11-FEB-2007 the physician developed two vesicular shingles lesions at the C8 dermatone. She also had other exposures to patients with herpes zoster. On 12-FEB-2007 she began therapy with valcyclovir. The physician has a history of chickenpox as child. Additional information has been requested. This is in follow-up to report (s). Additional information indicated that physician developed herpes zoster 22 dyas after VZV exposure during patient care, which lasted for less than 1 hour. On 11-Feb-2007 the physician developed herpes zoster on the right C-8 dermatone. Her maximum teperature was 98.6 F and other systemic symptoms included myalgia. The physician has a history of chickenpox as child at age 10. the physician was enrolled in Varicella zoster. Indentification Program to identify if VZV is prevent and if it is present to identify if it is associated with the wild (WT) VZV strain or with the Merck vaccine VZV strain. Specimens were obtained on 13-Feb-2007 from vaccines on th right arm C-B dermatome. Both specimens were negative, no VZV was identified. Subsquently the physician recovered completely from her experiences and was doing fine. No further information is expected.
This spontaneous report as received from a healthcare worker (office manager) and from medical assistant refers to a patient of unknown age and gender who on 06-MAR-2015 was vaccinated with improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No symptoms were reported (no adverse event). It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected because there is not permission for the physician to be contact.
This spontaneous report was received from a registered nurse regarding unknown number of patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, unknown number of doses of ROTATEQ (lot# M004885 with expiry date: 23-OCT-2017, M019708 with expiry date: 25-OCT-2017, M025563 with expiry date: 06-NOV-2017 and M004890 with expiry date: 10-NOV-2017) (dosing details were not reported) were administered to unknown number of patients following a temperature excursion of 33 F for 23 days. No adverse effects were reported. No product quality complaint was reported. This is one of the several reports. Additional information is not expected as there is no consent to contact the reporter.
swelling at the injection site; Had covid in February; Had covid in February; This is a spontaneous report from a contactable other HCP (Patient). A 78-years-old female patient received BNT162B2 (BNT162B2), formulation: Solution for injection, Lot Number: EL9269), dose 1st via an unspecified route of administration, administered in Left arm on 08Feb2021 as single dose for COVID-19 immunisation. The patient medical history included infectious thyroiditis from 2014 to an unknown date thyroid removed in 2014 or 2017, lymph node abscess from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing, immune system disorder from an unknown date and unknown if ongoing, respiration abnormal from an unknown date and unknown if ongoing, cytogenetic abnormality from an unknown date and unknown if ongoing, endocrine disorder from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing obesity from an unknown date and unknown if ongoing, covid-19 from Feb2020 to an unknown date. Concomitant medication(s) included azithromycin (AZITHROMYCIN) taken for an unspecified indication, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced had covid in february (drug ineffective) (medically significant) on an unspecified date with outcome of unknown, had covid in february (covid-19) (medically significant) on Feb2020 with outcome of unknown, swelling at the injection site (vaccination site swelling) (non-serious) on an unspecified date with outcome of unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed should the additional information be available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Immunizations were given at 11:00AM.  By 4:00-5:00PM pt had a fever (temp not taken).  Pt had a febrile seizure.  Parents called 911.  Pt taken to ER.  Temp was 104 degrees.  UA was neg.  Dx: febrile seizure.  Parents instructed to give Motrin before and after pt. receives shots in the future.  Fever gone after 24 hours.
Patient has large, raised and swollen red ring around injection site; says that it sometimes itches; did not occur during first dose in 2-dose series.
SWELLING AND REDNESS TO INJECTION SITE AND SURROUNDING AREA. GIVEN ZYRTEC AND BACTROBAN OINTMENT.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 20-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.  Patient had called to report that he had headaches few hours after taking the Moderna vaccine.
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 22-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R011805 and expiry date 23-APR-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
This spontaneous report as received from a 55 year old female patient refers to herself. On 24-MAY-2014 the patient was vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number, expiration date were not reported). On 03-JUN-2014 the patient experienced (6) red bumps in total that become hardened, 2 bumps along her neck and 1 at each elbow and each of her shoulders. The outcome of reported adverse events was reported as not recovered/resolved. The relatedness between adverse events and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information has been requested.
3inch red welt on Lt. deltoid x 10 days.  Awoke on day after 1st injection with the welt.    itchy.
pt recv vax AUG94 & 2 wk later exp rash which began @ inj site & spread over entire body; rash was described as little pimples & it also itched & turned somewhat brown in color; hypersensitivity;
Pityriasis rosea-like truncal rash. Appears very similar to previously diagnosed pityriasis rosea that occurred 2 years ago, with larger herald patch and several other smaller lesions on trunk. Does not itch or flake.
Next day had mild chills and headaches that lasted two days. Five days later developed a severe migraine headache. This is the first migraine I have had in over six months. Migraine lasted April 10th thru 11th, with extreme vertigo. Mild after effects lasted for one full week.
NO ADVERSE REACTION WAS GIVEN IN ERROR TO A PATIENT UNDER THE AGE OF 18
patient felt faint and that her throat was closing up after 2 minutes.. called 911 and administered 1 epipen in left lateral thigh. patient responded quickly with proper color and felt much better according to patient. I observed patient for 30 minutes and after her mother and her confirmed her as feeling just fine, the patient and mother left the pharmacy.
Pt playing in floor after immunization. Developed whelp left arm surrounded by redness. Spider later killed in exam room.