chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 inch by 3 inch red area on left arm; soreness at injection site; Swelling at the injection site; low grade temperature at the injection site; low grade temperature at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix (injection). On 21st January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling, injection site warmth and fever. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling, injection site warmth and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and fever to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had a 3 inch by 3-inch red area on the site of the injection in the left arm.   The patient also had soreness, low grade temperature, and swelling at the injection site.  The patient wanted to know if she would be okay and not get shingles if she did not get the 2nd injection.   Medical Disclaimer provided to caller, along with PI and consumer facts provided in content. The reporter was consented to follow up.
This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired vaccine used) and product administration error in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Oct 8, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 8, 2021, patient administered expired product (expired vaccine used) and product administration error. On Oct 8, 2021, administered expired product (expired vaccine used) and product administration error resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-392935 (patient link).
PATIENT HAD REDNESS, PUFFINESS, AND WAS ITCHING NEAR THE INJECTION SITE.  SHE WAS COUNSELED TO TAKE BENADRYL AND THE AREA LOOKED BETTER THE NEXT DAY.
4 hr after IM injection intense pruritus redness and edema developed 12x11cm (R) deltoid Tx with oral antihistamines and topical cortisone cream
LACRIMATION; MUSCLE CRAMPS; JOINT ACHES; CHILLS; FEVER; HEADACHE; TIREDNESS AND  FATIGUE; This spontaneous report received from a patient concerned a 63 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: Unknown) dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-MAR-2021, the subject experienced joint aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. On 23-MAR-2021, the subject experienced headache. On 23-MAR-2021, the subject experienced tiredness and fatigue. On 24-MAR-2021, the subject experienced lacrimation. On 24-MAR-2021, the subject experienced muscle cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.6 F, 100.6 F. Treatment medications (dates unspecified) included: magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps, and headache on 24-MAR-2021, was recovering from fever, and chills, and had not recovered from joint aches, tiredness and fatigue, and lacrimation. This report was non-serious.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 02-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008981, 1405USA008982). Additional information has been requested.
Alopecia; Patient's head stared itching; Patient's head stared flaking; Patient's hair started to fall out; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Patient's head stared itching), SKIN EXFOLIATION (Patient's head stared flaking), DERMATITIS (Patient's hair started to fall out) and ALOPECIA (Alopecia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Alopecia since 27-Jun-2021 and CIDP. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) and TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Patient's head stared itching), SKIN EXFOLIATION (Patient's head stared flaking) and DERMATITIS (Patient's hair started to fall out). On 27-Jun-2021, the patient experienced ALOPECIA (Alopecia). The patient was treated with CLOBETASOL ongoing since an unknown date for Itchy scalp, at a dose of 1 dosage form. At the time of the report, PRURITUS (Patient's head stared itching) and SKIN EXFOLIATION (Patient's head stared flaking) had not resolved and DERMATITIS (Patient's hair started to fall out) and ALOPECIA (Alopecia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-229344.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant follow up received on 01-JUL-2021. Medical history, Concomitant products and treatment medication ,drug information  and events were reported.
SEVERE HEADACHE; This spontaneous report received from a consumer concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced severe headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe headache. This report was non-serious. This case, from the same reporter is linked to 20210932604.
Dose given was expired.  mom notified of error  and that dose should be repeated.  no  signs or symptoms note.
Patient was given wrong immunization. Received PREVNAR 13, Hib, and Hepatitis B but needed IPV and Hepatitis A.
Administered expired vaccine to the patient after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient after the manufacture date of expiration.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  It was reported that it was unknown when the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non-Significant follow up.
Thought it was a rotator cuff injury, trouble lifting arm over shoulders, pain is better than it was and is improving.
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 16-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
Chills, achey muscles & joints, tired.  Lasted about 8 hours.
Pt got first dose of Covid-19 vaccine of Moderna on 6/15/21, and I gave pt the second dose a Covid-19 Pfizer vaccine.  Pt has no adverse events or symptoms.
I have had three significant nosebleeds following my 3rd Pfizer COVID vaccine, two occurring on Friday August 27 and one on Sunday August 29 . The first nosebleed occurred during my sleep and woke me up during the night. All of the nosebleeds took between 20-45 minutes to stop after pinching my nose. I have not had significant nosebleeds in over 15 years so this was highly unusual. I saw an ENT doctor who said it was very unusual to get such nosebleeds during the night, as this is far more likely to happen during the winter.
Child contracted Pertussis despite having been vaccinated against it. Diagnosis was confirmed by respiratory swab.
4/09/08 left deltoid sore after shot given later in day.  4/11/08 nurse noted after lunch around 2:00 pm area where small pox given 20 years ago red, hot to touch and swollen touchy.  Had used ice pack 4/10/08 with only wash cloth.  Advise use cool wash cloth only 4x daily and Ibuprofen as on package.  Saw NP later 4/11/08, better 4/14/08.  Saw NP 4/14/08 and has appointment 4/18/08 to see again - looks much better today 4/15/08.  Redness gone, less swelling and soreness using cool compresses and Ibuprofen.
Patient developed pericarditis within 5 days of flu shot. Patient was taken into the ED and discharged the same day with indomethacin rx. Some case studies and case series exist supporting this hypothesis.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 47 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 20Apr2021 as dose 2, single (Lot number: EW0162), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive, notes: Positive Covid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Severe fatigue; Severe vertigo; Severe muscle aches; Lots of muscle twitching; Pain in arm; Pain of injection site; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included narcolepsy, diabetes, arthritis and peripheral neuropathy. The patient had unspecified allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included exenatide (BYDUREON), glimepiride (MANUFACTURER UNKNOWN), pioglitazone (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and meloxicam (MELO); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 26Mar2021 at 03:30, the patient experienced severe fatigue, severe vertigo, severe muscle aches, lots of muscle twitching and pain in arm of vaccination site. Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of the events severe fatigue, severe vertigo, severe muscle aches, lots of muscle twitching and pain in arm of vaccination site were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 month old / patient received a Boostrix injection; 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 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 3rd June 2021, the patient received Boostrix (intramuscular). On 3rd June 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter informed that 15 month old patient received a Boostrix injection, which led to inappropriate age at vaccine administration. No patient initials or DOB (date of birth) was known or provided. The reporter consented to follow up.
Information has been received from a physician via a field representative concerning two unspecified patients of unknown age and gender. No medical history, drug reactions and concomitant medications was reported. On an unknown date, the two patients each received their dose of GARDASIL 9 injection (lot#, dosage and route not provided) too early (inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
Fever lasting approximately30 hours; chills - shivering;  stiff neck; muscle aches and pains - entire body; back  pain - feeling like it needed to be "re-aligned;" muscle cramps in legs and feet; exhaustion - slept for 24 hours (with 2 breaks to eat, each an hour long); dizziness/lightheadedness.
Pt received the covid vaccine dose #2 on 01/13/2021.   She called today, 1/19/2021 (second time) to report that she has  new symptom of sore throat and  neck swelling bilaterally. No fever.  Previously, she called on 1/11/2021 to report fever, HA, dizziness, bodyache, and L axillary swelling and tenderness. Since, these symptoms have resolved but still have mild tenderness of the L axillary area.   Last covid test was 1/13/2021 was negative.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. On an unknown date the patient experienced an adverse event. The patient stated that after receiving the ZOSTAVAX they had an injection site reaction on an unspecified date that created pain, discomfort and swelling. "The discomfort was worse when coming into contact with clothing". It was unknown if the patient sought medical attention. The outcome of adverse events was unknown. Additional information has been requested.
h/a, eyes blurry, throat sore-stuffy head; improving now 19OCT94;
5:30 am I found husband by bed, babbling, Called 911, Had Lt Hemi Stroke. Aphasic, Rt side limp, given TPA. Sent to ICU. Recovered within 2hrs, speech, movement of extremities. lt hemi clot found on ct angiogram & mri. 2nd mri found clot busted with residual. transfered to telemetry next nite. echo unconclusive. 02 sats low, venogram done 3days later show lt dvt, lung ct wnl. ld asa & b/p meds were given. blood work to be drawn for baseline prior to anticoagulent therapy. possible d/c 9/30.
This case was considered medically important. Information regarding Hib titer vaccine was received from an attorney regarding a patient who received "3 or 4cycles and than came down with Haemophilus Type B. On unspecified dated, the patient received "3 or 4 cycles" of Hib-Titer. On an unspecified date, the patient "came down with Haemophilus Type B (drug ineffective). It was unknown if the patient recovered from the event. No additional information was available at the time of this report.
Refridgeration excursions identified; No adverse event; Refridgeration excursions identified; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jul-2022 at 11:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2022 at 11:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Refridgeration excursions identified).    No concomitant information was reported. Injection site given as Deltoid. Dose/volume given as 0.25 Product was reported as Monovalent. Storage condition at the time of the excursion was Refrigerator. Date the vial moved from freezer to refrigerator was 7Sep2022, monovalent vaccine. it was reported that unbroken carton, vials were not visualized and None proposed. There were excursions noted. No adverse reactions reported to reporters knowledge for patient. No treatment information was reported.
Small bumps all over his skin; Migraine; Information received from a consumer on 01MAY2019.   A male patient aged 18 years experienced small bumps all over his skin following the administration of ACAM (smallpox (vaccinia) vaccine live).   On 22APR2019, the patient received ACAM dose in the upper left arm (route, lot and dosage unknown).  On 29APR2019, patient revisited the facility that had vaccinated him and the doctor reported that the he was healing. The patient reported that for the last two days (30APR2019), he had developed small red bumps all over his skin and also had migraine for two days. Patient had a concern that he might have accidentally inoculated himself because the vaccination area was covered except for one night when he had left it open to air out.  He also stated that he knows it did not come in contact with anything. Patient has been on internet and doesn't think his bumps look like smallpox. He denied to provide any further information and does not want to go through an adverse event report. Outcome of the event at the time of report was unknown.  Patient's medical history was not reported.  Allergies: not reported  Concomitant medications and Concurrent Medical conditions: not reported  Company Comment: There is not enough information to properly assess this case. The Company considers that the macular rash is not assessable and the diagnosis of autoinoculation cannot be made. The reporter was concerned of possible autoinoculation but he ruled out himself of the possible autoinoculation. it is odd that one day after the doctor's no lesions were noted. Migraine is not a known phenomenon of  ACAM2000.and considered not related.
Gave a booster dose (0.25ml) to a patient who was eligible for a full 3rd dose (0.5ml) for the immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave a booster dose (0.25ml) to a patient who was eligible for a full 3rd dose (0.5ml) for the immunocompromised) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 013M20A and 082A21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Immunocompromised.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Gave a booster dose (0.25ml) to a patient who was eligible for a full 3rd dose (0.5ml) for the immunocompromised). On 05-Nov-2021, ACCIDENTAL UNDERDOSE (Gave a booster dose (0.25ml) to a patient who was eligible for a full 3rd dose (0.5ml) for the immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown.  Patient was eligible for the full 3rd dose (0.5 milliliter) for the immunocompromised due to a history of liver transplant, however, patient received 2.5 milliliter dose. The patient cannot return to the pharmacy until next da, and they want to know how to proceed with completing dose.