chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious Spontaneous report of "Administered a full dose into one nostril and another full dose into another nostril in same visit" was received from a Consumer/non-health professional concerning a Male Patient of unknown age. The relevant medical history has not been reported for this Patient. On 25-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
redness; swelling in the left arm; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in the left arm) and PRURITUS (itchiness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dry mouth and Sjogren's.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in the left arm) and PRURITUS (itchiness). At the time of the report, ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in the left arm) and PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of (Merck) VARIVAX (lot # L034370 with expiration date 08-SEP-2017, lot # L038132 with expiration date 01-OCT-2017, lot # reported as L042266 with expiration date October 2017, lot # reported as L049532 with expiration date 08-DEC-2017; dose and route of administration were not reported). No adverse effects were reported. The call was made because of the data logger. (Merck) VARIVAX with lot # L034370 and with lot # reported a L042266 were stored in 7.6 degrees of Celsius for 49 hours. (Merck) VARIVAX with lot # L038132 and with lot # reported as L049532 were stored in -12.2 degrees of Celsius for 1 hour. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
patient was accidentally given 3rd dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 31-OCT-2022 Reporters comment: The health care professional reported that patient was accidentally given 3rd dose of Shingrix. The reporter disconnected from the chat. No additional information was available. The reporter did not consent to follow-up. Additional Supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Information has been received from a 68 year old female patient, referring to herself. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On an unspecified date in June 2008, the patient was vaccinated with a dose of ZOSTAVAX refrigerated vial 19400 PFU, administered subcutaneously (lot number and expiration date were not reported) for prophylaxis (reported as prevention of shingles). On 13-OCT-2014, the patient developed a pimple-like bump on her forehead near her eyebrow, which began to spread to her scalp. The patient visit her dermatologist, who confirmed that she had shingles. Consequently, the patient was treated with azithromycin (Z-PAK) and other unspecified medications (at the reporting time, it was uncertain of medicines received, including the azithromycin (Z-PAK)). No lab diagnostics studies were performed. The patient reported, that about 3 weeks later (on approximately 03-NOV-2014) the shingles rash began to clear up, and eventually went away (on an unspecified date in 2014). The Additional information has been requested.
Headache; Nausea; 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 female patient received bnt162b2 (BNT162B2), administration date 31Jul2021 (Lot number: EW0168) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Hypertension; "pituitary brain tumor" (unspecified if ongoing), notes: verbatim: pituitary brain tumor; "heart palpitation" (unspecified if ongoing), notes: verbatim: heart palpitation. Concomitant medication(s) included: ATENOLOL. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea". Therapeutic measures were taken as a result of headache.  Additional information: Patient stated that she took that Pfizer shot about a week ago on Saturday. She had been having a headache ever since. She saw her doctor on 02Aug2021, endocrinologist, because she does have a pituitary brain tumor (history), but it had been in remission. She said that the side effects or headache would only be for two to three days. So, she was still having this headache. Patient stated, she visited lab on 02Aug.Treatment in response to adverse event: Patient stated she was taking over the counter Advil right then. All she took was Advil. Patient further stated that, she had little nausea too, so she did not know if that was the same thing or what. She just wanted to know because her doctor was telling her to drink a lot of water and until that she was doing that. Consumer stated, EW0168 wait a minute it looks like a B it could be B, her handwriting is terrible. Yes, it could be B as bravo (Consumer was unsure, hence not captured in tab). Prior vaccination (within 4 weeks), consumer stated, no, this was her first one and she was apprehensive about doing that.  Follow-up attempts are completed. No further information is expected.
Headache, Myalgia & Fever Narrative:  fever, myalgia, fatigue, headache
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    This case was created for 33rd patient of 56 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
On 8-3-11 received HPV #2. 5-7 days later c/o numbness in arms & lasted 2 weeks off & on. On 8-20-11 she collapsed - had complete paralysis in hospital for one week then transferred to another hospital. Has had concentration problems and faint problems since.
Temperature 102 and chills Painful Joints Extreme fatigue  General flu-like symptoms.
February 11, 2021, at 8:00PM. Swollen nipple on right side, same side as Moderna vaccination. No treatment, Nipple enlarged and hard, sensitive. Begins to subside in 24 hours, but still sensitive and slightly enlarged as of today.  February 15, 2021, at 8:30AM. Rash on right arm, same arm as Moderna vaccination. No treatment. Blotchy, smallish red bumps on arm near injection site, appears as red rash about three inches long and one to two inches wide. Not itchy or painful. A few days earlier, I had bumped my shoulder at the injection site rounding a corner in the house experiencing mild soreness at the injection site.
Itching on scalp, inside ears, and inside nose.  It started about 20 minutes after injection. I asked the woman that was in the observation area if I could take an Allegra if these symptoms continued.; This is the reaction the patient normally have to some medications that she is allergic to; This is a spontaneous report from a contactable consumer.   A non-significant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 15Feb2021 16:00 (Batch/Lot Number: EL9266) as dose 1, single (at the age of 64 years old)  for COVID-19 immunisation.  Medical history included none. Concomitant medication included pravastatin taken for an unspecified indication, start and stop date were not reported. On 15Feb2021 16:30, the patient experienced itching on scalp, inside ears, and inside nose. It started about 20 minutes after injection. The patient asked the woman that was in the observation area if she could take an ALLEGRA if these symptoms continued. They were mild. The patient took an ALLEGRA and 20 minutes later the itchiness was gone. This is the reaction the patient normally have to some medications that she is allergic to. No COVID prior to vaccination and after vaccination. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Patient received a dose and a little leaked out at site.  Patient did not receive a second dose due to receiving at least 1/2 the dose administered.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 5 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site itching and injection site pain were not recovered/not resolved. The reporter considered the injection site erythema, injection site itching and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was the nurse at a health clinic reporting an adverse event on behalf of a patient. The reporter stated that the patient received the SHINGRIX vaccine and 5 days later had a red, sore, itchy area at the injection site. The reporter stated that they would have the patient come back in to see the doctor. The reporter had limited information regarding the patient and the event during the call.
SHE GOT A FEVER ON 10/15. THE FEVER GOT UP TO 104. LASTED UNTIL 10/17. SHE WAS ADVISED TO GO TO THE EMERGENCY ROOM ON 10/17 BY DR., BUT HER FEVER RESOLVED LATER THAT DAY. SHE IS NOW AFEBRILE AS OF 10/17.
Nauseous; Headache; Pain in the joints; Wanted to vomit, but nothing was coming up; Temperature dropped to 95.8degrees; Not being able to eat; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), CHILLS (Chills), NAUSEA (Nauseous) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 25-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 CHILLS (Chills). On 26-Feb-2021, the patient experienced BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), NAUSEA (Nauseous), HEADACHE (Headache), ARTHRALGIA (Pain in the joints) and VOMITING (Wanted to vomit, but nothing was coming up). On 25-Feb-2021, CHILLS (Chills) had resolved. On 02-Mar-2021, BODY TEMPERATURE DECREASED (Temperature dropped to 95.8degrees), FEEDING DISORDER (Not being able to eat), HEADACHE (Headache), ARTHRALGIA (Pain in the joints) and VOMITING (Wanted to vomit, but nothing was coming up) had resolved. At the time of the report, NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 95.8 (Low) Temperature dropped to 95.8degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. Treatment information were included heating pads and blankets.
PATIENT RECEIVED A FULL THIRD DOSE DUE TO BEING IMMUNOCOMPROMISED (ON CHRONIC STEROID THERAPY). HE BECAME SEVERLY WEAK AND DIZZY RESULTING IN A FALL WHERE HE BRUISED HIS FACE AND BROKE SEVERAL TEETH. HIS DIZZINESS AND SEVERE FATIGUE PERSISTED FOR TWO DAYS WHEN I FOLLOWED UP WITH HIM.
Pt noted tightness/swelling around eyes along with itching/burning sensation at same.  Then developed itchy erythematous rash starting right shoulder (near where injection was done) and spreading to back.   Benadryl 50mg IM given.  Was sent to ER for continued monitoring; she did well without further treatment (other than 500mL of saline IV) and was released in good condition.  She did not have lightheadedness, lip/tongue/throat swelling, SOB, GI symptoms, or hypotension.
Breakthrough case admission after 2 vaccines MOderna 3/29/21 lot# 023M20A ; Moderna 4/8/21 lot# 018B21A
A Pfizer COVID-19 Bivalent ages 12 years and older booster dose was administered to a 10-year-old patient.
While in observation, patient reported being very hot and itchy.  Rash on chest, neck and arms.  Complaining of throat feeling a little tight prior to going to ED.  While in Ed, given famotidine, solumedrol, and Benadryl.  Prescribed EpiPen, famotidine and prednisone at discharge.    Patient states she has rash on chest, neck and arms after 1st vaccine and was given Benadryl and steroid shot.
pt recv 2n dose of vax approx in 8/97 & in 8/98 pt lab evaluation revealed a lack of seroconversion.
itching from her hips up all over her body; elevated T3 levels; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced generalized pruritus and tri-iodothyronine increased. On an unknown date, the outcome of the generalized pruritus and tri-iodothyronine increased were unknown.   It was unknown if the reporter considered the generalized pruritus and tri-iodothyronine increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced itching from her hips up all over her body and had blood chemistries drawn and T3 was three times normal value. The reporter stated that, the patient had no sign of rash and was seen by dermatologist and endocrinologist. The reporter did not consent to follow up.
Patient had pain and swelling at the injection site and was seen by an urgent care doctor who stated she had cellulitis. He indicated it was due to the vaccine.
Extreme body aches and chill started around 4:00 and continued throughout the day. Took tylenol but it did not help.
This spontaneous report as received from a 64 year old female patient with allergy to penicillin and allergy to KEFLEX. The patient's medical history included chicken pox virus in the past (date not specified). On approximately 14-JUL-2014, reported as about 4 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX single injection in her arm (exact route not specified). Concomitant medications were not specified. On approximately 14-JUL-2014, reported as about 4 weeks ago, the patient experienced injection site reaction in the form of a rash and break out in hives. The patient sought medical attention and received treatment (unspecified corticosteroids, route not specified) from a dermatologist. No lab diagnostics studies were performed. The outcome of injection site reaction in the form of a rash and breaking out in hives was reported as fully recovered on 11-AUG-2014. The relatedness between and injection site reaction in the form of a rash and breaking out in hives and ZOSTAVAX was not reported. Additional information is not expected.
After being dormant for ~60 years, Herpes simplex keratitis of right eye reappeared. In Dec 2021, after being dormant for 5 months, Herpes simplex keratitis of right eye reappeared.  Corneal neovascularization, right eeye.
I received my 1st dose of Covid 19 Pfizer vaccine 2/27/2021 at approx. 12:30. The next day 2/28/21 approx. 10:30 I had lost circulation to my fingers an toes where they turned white and numb. Later When visiting my doctor I had confirmation that it was Raynaud's which I had never experienced before the vaccination.
SWEATING; FELT VERY SICK; LEG SORENESS; SEVERE HEADACHE; FEELING HOT; TINGLING IN RIGHT ARM/LEGS; This spontaneous report received from a patient concerned a 51 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: 041A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced tingling in right arm/legs. On 12-APR-2021, the subject experienced feeling hot. On 12-APR-2021, the subject experienced sweating. On 12-APR-2021, the subject experienced felt very sick. On 12-APR-2021, the subject experienced leg soreness. On 12-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling hot, sweating, felt very sick, leg soreness, and severe headache on 12-APR-2021, and tingling in right arm/legs on 11-APR-2021. This report was non-serious.
Information has been received from a nurse practitioner concerning a 25 year old female employee who on 27Jan04 was vaccinated with a dose a varicella virus vaccine live. The nurse practitioner reported the pt developed four lesions on her trunk and arm one week post vaccination. She also experienced pruritus. The nurse practitioner reported the pt did not require treatment for the adverse event. It was noted the lesions lasted 2 weeks then resolved and the pt recovered. There was no product quality complaint involved. No other information was available. Unspecified medical attention was sought. Additional information has been requested.
PATIENT GIVEN VACCINE AND WENT TO SIT IN WAITING AREA, THEN STARTED FEELING BAD,HE GOT UP WITH IN A FEW MINUTES AND KNOCKED ON DOOR. AS PHARMACIST OPENED DOOR HE FAINTED AND FELL ON THE FLOOR. PATIENT WAS SWEATY AND COLD (FAINTED FOR LESS THAN A MINUTE). RX CALLED 911 - MOTHER WAS THERE AND ONCE PARAMEDICS CAME THEN TESTED BLOOD GLUCOSE AND HE FAINTED AGAIN IN FRONT OF THE PARAMEDICS. EVERYTHING WAS OK AFTER A FEW MINUTES.  THE PARAMEDIC RECOMMENDED TO GO TO THE HOSPITAL SINCE HE FAINTED TWICE AND THEY TOOK HIM TO THE HOSPITAL.  RPH ON DUTY CALLED MOM AT 8:44PM AND PATIENT WAS STILL IN THE HOSPITAL BUT THE MOTHER SAID EVERYTHING WAS OK AND THAT THEY WERE WAITING FOR THE MD TO SPEAK TO THEM.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 5-month-old male patient who received DTP (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, less than a year after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine. Additional details were reported as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient became very ill and was hospitalized. The reporter stated that, It was a long and scary three months and the vaccines are garbage and do more harm than good. This case was considered as suspected vaccination failure since time to onset for the event was unknown. The reporter did not consent to follow up. This case was linked to case US2017GSK141271, reported by the same reporter.
Pt stated he woke up with a swollen arm- called the hospital and they had him be scheduled with PCP. Pt came in 03/17/21 at 1:00PM with a swollen left arm and was warm to the touch. Provider ordered a Dexamethazone injection, I gave pt injection in right deltoid- pt wait x15mins and left with no adverse reactions from injection. Provider instructed pt "if not better by tomorrow (03/18/21) get Rx for Cephalexin.