chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse reaction; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse reaction) in an elderly 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. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 patients received an additional 0.25 ml).    This case contains information about the 15th patient out of 27 patients as described by the reporter.  All the patients were over the age of 65 years.  No concomitant medications were reported.  The first booster dose of vaccine was administered in the deltoid site.  On 10-May-2023, 27 patients received 0.25 ml booster dose of the Moderna bivalent vaccine instead of 0.5 ml dose.  On 11-May-2023, 26 patients were contacted, and on 12-May-2023, 18 patients received an additional 0.25 ml booster dose, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25 ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be contacted by phone.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case
6 days after my shot, I developed an itchy rash with moderate swelling on face mostly, neck and wrists.  I am not sure of the cause - it was clearly some kind of allergy, possibly a contact allergy, but I am not sure if it is connected to the vaccine or not.  I was advised to report it. It was bad enough to have been prescribed prednisone
pt recvd vax & exp diffuse macular rash, some post auricular nodes & post occipital nodes, fever 29 & 30APR;  MD felt rash p/MMR was not uncommon & no blood tests nec uncless it gets worse;
Temp 101.6, shaking chills. Slight erythema below injection site with minor swelling
Inappropriate schedule of vaccine administered; headache; muscle pain; chills; fever; This is a spontaneous report from a Pfizer sponsored program "Pfizer First Connect" from a non-contactable consumer (patient's husband).   A female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 05Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient received, on 19Jan2021, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, for COVID-19 immunisation. On an unspecified date, in Feb2021, the patient experienced headache, muscle pain, chills and fever. He is asking if her wife can take naproxen sodium or ibuprofen. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
Pt. reported development of redness and swelling below injection site; received injection at 11:57 AM, and symptoms developed that same evening on 11/12/08. Treated with Cephalexin 250 mg, one capsule four times a day for 10 days.
Patient felt terrible/patient felt really really bad; Weakness; Disorientated; Sore arm; Swelling in the site of injection; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt terrible/patient felt really really bad), ASTHENIA (Weakness), DISORIENTATION (Disorientated), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE SWELLING (Swelling in the site of injection) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041F22A) for COVID-19 vaccination.     It was reported that patient never had COVID + test or diagnosis.  It was reported that there was no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Thyroid operation (thyroid  replacement). Concurrent medical conditions included Allergy (x-ray dye allergy), Drug allergy (statins allergy), Kidney failure and Blood pressure high.    On 04-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Nov-2022, the patient experienced FEELING ABNORMAL (Patient felt terrible/patient felt really really bad), ASTHENIA (Weakness), DISORIENTATION (Disorientated), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE SWELLING (Swelling in the site of injection). On 09-Nov-2022, FEELING ABNORMAL (Patient felt terrible/patient felt really really bad), ASTHENIA (Weakness), DISORIENTATION (Disorientated), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE SWELLING (Swelling in the site of injection) had resolved.            Patient mentioned she was under treatment for high blood pressure and also medicine for thyroid replacement, but did not remember the names.  It was reported that there was no recent change in status such as improvement or worsening.  AE did not caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The patient had not experienced a similar event in the past.  No treatment was given. No concomitant medication was provided.
DOSE ADMINISTERED AFTER BEING STORAGE FOR 30 DAYS BETWEEN DEGREE X
Painful at injection site with raised red rash radiating from upper left arm down to forearm.
About 4 hours after getting the vaccine, I became very tired. Soreness on area of vaccination.  7 days after the vaccine, area surrounding the vaccination area became swollen and stayed that way for about 3 days. No other symptoms other than these listed.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 28-MAR-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. Additional information has been requested.
pulmonary embolisms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolisms".  Clinical course: Reporter stated that covid vaccine almost killed reporter, her son and her daughter. All 3 of them developed blood clots (pulmonary embolisms) in the same time frame after getting the vaccine. They have all suffered life changing effects and had been ongoing medical issues as well as dollar of medical bills. And no they were not old and fat and out of shape. In fact, if it hadn't been for being somewhat in shape none of them would have lived through it.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & approx 2wk later pt devel a flat rash w/o vesicular lesions;
Malaise , body aches starting the day after vaccines were given and lasting 3 days.  Then noted hives and purple discoloration of both distal arms and hands and hives for 2 days, which responded to Benadryl.  Now resolved
Information has been received from a registered nurse concerning a female who on 21-SEP-2007 was vaccinated IM, into the deltoid, with a dose of PNEUMOVAX 23 (lot #655289/0958F). Subsequently, the patient developed redness from injection site of deltoid down to the elbow. The patient was treated with KEFLEX. On 24-SEP-2007, the patient was seen in the physician's office. At the time of the report, the patient had not recovered. The registered nurse requested a lot check. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released.
Extreme nausea (for both vaccines doses) for 3 days. Diagnosis of anemia. No history of anemia. Donated blood April 2021 where my iron levels were checked without any issues.
Vaccine given at 1900 in right deltoid. About 2 hours later itchy red bumps observed on right forearm, seemed to be following veins in arm. Nothing observed near injection site. Oral benadryl given, no worsening of bumps noted. About 1 week later bumps are still present, have started to scab over.
Severe left ear tinnitus  Left lower eyelid twitching  Dizziness  Continuing for 7 weeks now every day all day
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 01-FEB-2016, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2016, the patient was treated at a hospital for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. She was prescribed antivirals for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Violent itching, injection site side and face. Extreme eyes watering, nose running excessively. Face beet red.   BP 140/80  Sent home told to take Benadryl.  Glands swollen and sore scratchy throat at home.   Took Benadryl. Slept.   Now 6 hours later glands swelling and extreme itchiness returning. Watery eyes
fever of 101.7, body aches and painful joints, nausea  I took ibuprofen and rested it lasted for about a 12 hour time period pain in the left arm and a large red painful bump at the injection site is ongoing as 72 hours from the shot
I got vaccinated last Friday afternoon, was sore Saturday morning, and got intense chills Saturday afternoon and went to bed (wore two layers of clothing and had three blankets plus my heater going).  On Sunday the 9th, early morning (4:20am), I went to the restroom and passed out/fell after washing my hands.  It happened again trying to get to my room, and a third time trying to turn on my light when my roommate called out wondering what all the noise was.  My speech was slurred, my vision black and fuzzy, and I could barely hear her voice.  I also was sweating a lot.  It took about five minutes for me to become coherent enough to call the 24 hour nurse line.  Though I was coherent, I couldn't stand without feeling dizzy, and was advised to call 911.  Paramedics ran tests to see if my blood sugar/anything stroke related could be the cause, and the doctor/nurses at the ER ran blood tests as well.  Everything came back normal, and they concluded my passing out was likely due to the vaccine.  I was discharged around noon, and since then have not fallen or felt the same level of dizziness.
HPV vaccine was given outside of age range. No adverse reactions occured. PT recieved one HPV vaccine on 14 May 2013 and a second 30 Jul 2013. Pt was denied third round of vaccine due to age limit and no provider order.
Received injection about 1024 AM. Had progressive fatigue throughout the day  and went to bed at 9PM.  Approximately 4AM I woke up but had not strength to get out of bed or even roll over.  I had  severe weakness,  muscle aches, and extremely  dizzy and became incontinent of urine.  I required help from my husband to get in and out of bed. these symptoms lasted until approx. noon on November 20, 2021 The dizziness persists.
Pt exp t103, h/a, flushing, sweating, constipation, malaise, back pain, chills, abdominal cramps & weakness on 6MAY92 @ 5PM following Engerix-B;
Information has been received from a licensed practical nurse concerning a 40 month old male, weight 29.5lb height 35 inches, who on 28-Feb-2006 was vaccinated with VARIVAX (Oka/Merck) (Lot#: 650233/0912R) SQ and (CRM197) PRENVAR (lot#: B08643A) IM and FLUZONE (lot#:B08643A) IM and FLUZONE (lot#: 41804AA) IM. On 23-Jun-2008 the patient developed papular/pustules lesions in trunk, scalp and a few in arms. The patient's outcome was not reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 22-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reproter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Rash; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (Itchy). On 15-Feb-2021, the patient experienced RASH (Rash). At the time of the report, PRURITUS (Itchy) and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient mentioned as currently taking other medication.  Treatment details included Rubbing alcohol
9/9/21 hx of anorexia, bulimia, depression, anxiety, Raynauds, pancreatitis, presents to ER for generalized weakness
pt recvd vax on 13APR92 & 6 hrs later devel pruritic macular sandpaper appearing rash-began around inject site & spread up arm & onto trunk; nausea, chills, fatigue, fever, blood tinged sputum, cough, hot & cold flashes; bruise was noted;
Information has been received from a pharmacy student concerning a 46 year old (also reported as greater than 26 years of age although exact age unspecified) female physician with oedema peripheral and acne and who was HPV positive prior to vaccination who on 13-SEP-2007 was vaccinated intramuscularly in the right arm with a 0.5 mL first dose of Gardasil.  Concomitant therapy included ALDACTONE TABLETS and doxycycline.  On 20-SEP-2007 the patient developed large generalized welts on the body.  The patient took diphenhydramine 12.5 mg 3 to 4 times for the reaction and stated that the "rash" was less severe as of "14-SEP-2007."  It was noted that the patient took the Gardasil at the recommendation of the patient's gynecologist.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested. Additional information is not expected.
Patient reports developing an itchy rash on entire torso on Jan. 15th.  She visited her pcp for follow-up, who indicated that this was a reaction to the vaccine. No medication was prescribed, and suggested to use OTC medication for relief.
A few days after the shot she experienced fetal demise at 30 weeks gestation.  10/26/09 Hospital records and discharge summary received. Service dates 10/21/09 to 10/22/09. Assessment: Status post delivery of intrauterine fetal demise, induced labor, stillborn infant. Estimated delivery date was 11/06/09.  10/26/09 PCP medical records received, includes vaccine records, service dates 6/8/09 to 10/21/09. Some duplication of hospital records. Revised estimated date of delivery 12/31/09. No fetal heart tones, no fetal movement for two days.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. SHINGRIX was discontinued. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced adverse effects and was hesistant to receive the 2nd dose of SHINGRIX. The case was linked with cases US2019023148 and US2019GSK027918 (husband's cases).
Patient was scheduled for Moderna vaccine and patient was given Pfizer vaccine.  No adverse reaction in the post-injection observational period.  Patient was called and followed up with the next afternoon.  Pt complained of a quarter-sized area of numbness at injection site.
labels provided by health department with the vial of moderna mrna bivalent were used on the consent but had incorrect dosage.  Correct dosage administered to adult male (0.5 ml) but documentation incorrect.  Documentation must be changed from 0.25 ml that is on the label to the 0.5 ml correct dose that was administered.  Documentation issue.  No patient harm.
Had 1 st shot on2/9 started to get a headache on the way home probably about 42 hours after shot. Got home and went to sleep. Slept for about 3 hours. Woke up crying with a severe headache. Took Advil. Went back to sleep. Slept all night, woke up next morning and was fine. No headache.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included degenerative disc disease (discs in neck slightly compromised). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.  It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had the typical symptoms soreness and redness at injection site. The patient mentioned she had some blood work done recently and would see her primary doctor on 6th February 2019. The patient declined to provide pharmacist's name and did not think there was an issue with technique. This was all the information the patient wished to provide and she would callback to provide additional information after seeing her physician. The patient declined the prescriber's information. For tolerance dose, see case ID US2019020206 reported for 2nd dose of SHINGRIX.
Swollen, hot, and red around the injection site. Arm is sore, oozing clear fluid from injection site.
Information has been received from a physician referring to unspecified patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unspecified. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L037565, expiration date 29-SEP-2017, dose and route unknown). The vaccine was stored under 22.6 F for 44 hours and supported until labeled expiry. There was no previous excursion. It was reported due to data logger. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Patient was given Bivalent booster today, pt did not have information on CDC card that pt received bivalent booster on 10/19/22. Facility did not make RN aware either. Pt tolerated the vaccine well, pt monitored for 15 minutes, pt had no signs/symptoms of any reactions.  Facility to monitor for any future adverse reactions and will notify health department.
INJECTION SITE STARTED WITH RED BLOTCH AND ITCHING, THEN WOKE UP TO WHOLE BODY COVERED IN HIVES LEGS, ARMS, STOMACH. STATED 1/7/2021 - CONTINUING
Pt has not reported any adverse event, but they inadvertently received a 2nd booster (4th dose), after stating that they were not immunocompromised.  1st booster was received on 10/26/21 and 2nd booster on 5/16/22/
Patient reported pain in the arm after COVID 19 booster shot. Patient believes this was an administration error & that is why she is having pain in her arm. Patient does not believe the pain is from the medication itself. This was a subcutaneous injection & her Pharmacist believes the injection did not go deep enough.