chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 77-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In March 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced vomiting, diarrhea, belching, weakness and dehydration. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with vitamins nos (Vitamins) and intravenous fluid (normal saline). On an unknown date, the outcome of the vomiting, diarrhea, belching, weakness and dehydration were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the vomiting, diarrhea, belching, weakness and dehydration to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine at the end of March 2018 on the left arm. The evening of vaccination he experienced vomiting, diarrhea and continuous belching. The patient felt weak and dehydrated. The patient visited his doctor on the end of third day because he was weak, dehydrated and belching. The patient was in his doctor's office for about an hour, he was given intravenous (IV) saline and vitamins. The patient recovered by the next morning. The patient wanted to know if he should get the second dose since it passed the 6 month window, which led to incomplete course of vaccination. The reporter consented to follow up.
The pharmacist gave PNEUMOVAX 23 to patient around 1 PM on Monday 2/12/18. Patient called the pharmacy around 8 PM on 2/12/18 complaining of redness, swelling, and arm warm touch. The pharmacist asked the patient to consult the doctor. Patient saw their primary care doctor on 2/13/18 in the morning and the doctor informed the patient to ice the site, gave her BENADRYL and ADVIL for her symptoms and asked the patient to call them back if the color of the site changed or the symptoms worsen.
Pt. developed 2 cm erythema at local injection site and scattered rash on body consistent with VARICELLA.
Pt received the incorrect vaccine. Pt was given Moderna Pediatric Monovalent NDC 80777-275-99 instead of Moderna Bivalent Booster NDC 80777-0282-05
This spontaneous report as received from a nurse via field representative refers to a female patient of unknown age with high blood pressure. On an unknown date the patient was vaccinated with GARDASIL (strength, formulation, lot#, dose/frequency, route and duration were unspecified). Patient developed facial numbness on the same day of the vaccination. Patient had sought medical attention via calling the office. No lab diagnostics studies were performed. The outcome of facial numbness was reported as recovered (date unspecified). Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of a 55-year-old male subject not responding to therapy following vaccination with TWINRIX for prophylaxis. On an unknown date, the subject completed a series of TWINRIX. A second three dose series of TWINRIX was started in March 2007. The 3rd dose of the second series was administered in September 2007. On month following administration of the 3rd dose of TWINRIX, on 30 October 2007, a titer was taken and showed that the subject was responding to therapy. He was hepatitis A antibody negative and had a hepatitis B antibody level of less than 0.1. At the time of reporting, the subject's lack of response to therapy was unresolved. Follow-up information received on 31 January 2008 indicated that the subject received a series of hepatitis immunizations several years ago.
Pt. noted hives on (L) foot night of 4/11/17 - AM of 4/12/17, hives spread to her legs and face. She took BENADRYL and subsided some, but coming back on arms, face, abdomen and back. DX allergic urticaria - possibly from TRUMEMBA or a viral rash.
Rash first showed on back, pruritic spread to chest, face, arms and scalp. Lesions different stages of development, occasional shell vesicles, redness to crusted over.
I had a miscarriage on 4/2 estimated and my estimated date of delivery 11/7/2021.
Pt recv vax on 1/5/99; on same day pt exp fever (105) & wheezing
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-APR-2016 the patient was treated (by an unspecified health care professional) at a medical center (hospital and ER) for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long term prevention of shingles, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Fast Heartbeat,Swelling in left hand and foot.In a six hour time frame.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt received flu shot in left arm. Within 1 minute she received moderna vaccine in right arm. Within 30 seconds of Moderna she fainted. She has a history of fainting due to fear of shots. She regained consciousness within 30 seconds and was kept under observation for 30 min. No lingering symptoms after 20 min.
PATIENT IS REPORTING A DEEP MUSCULAR PAIN IN HER RIGHT ARM SINCE THE FLU SHOT WAS GIVEN IN OCTOBER WITH NOT MUCH RELIEF. THE PAIN IS GREATER WHEN SHE MOVES HER ARM IN A CERTAIN WAY OR WHEN SHE LAYS ON IT AT NIGHT. SHE WENT TO HER PRIMARY CARE PHYSICIAN WHO GAVE HER AN XRAY. THE XRAY WAS CLEAR. THE PHYSICAN RECOMMENDED A FEW SESSIONS OF PHYSICAL THERAPY FOR THE PATIENT TO PREVENT FROZEN SHOULDER. THE PATIENT DID 3 TO 4 SESSIONS OF PHYSICAL THERAPY AND IT SEEMED TO HELP HER PAIN
Under age got the first dose of Moderna vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age got the first dose of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age got the first dose of Moderna vaccine). On 08-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under age got the first dose of Moderna vaccine) had resolved. Not Provided      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report as received from a medical assistant refers to a 2 month old patient of unknown age. The patient's medical history was not reported. On 16-AUG-2014 the patient was vaccinated with improperly stored ROTATEQ (dose and frequency were not reported, lot # J004944 and expiry date: 12-NOV-2014). No adverse symptoms were reported. The temperature excursions for the ROTATEQ was a supported excursion with in-house stability data. No product quality complaint (PQC) was reported for ROTATEQ. This case is linked to 1409USA0101041, 1410USA009191, 1410USA009192, 1410USA009194 and 1410USA009195 (same reporter link). Additional information has been requested.
Approx 1.5 hrs p/vax became limp to unresponsive, very pale, acted like was falling asleep, temp 103;
Vaccine given on 8/24. Patient first got rash on wrist 8/31 and has slowly spread to other areas of the body.  Patient went to pediatrician on 9/15 where other causes of rash were ruled out and was told to call a dermatologist. That appt is tomorrow.
Fever, chills, shaking, body aches, and underarm lymph nodes swelled more
Haemophilus influenzae type b meningitis w/septicemia; Ampicillin resistance tx Ceftriaxone;
Head cold; This is a non-serious spontaneous case, initially received from other health professional on 19-Feb-2019, concerning a 49-year-old, adult female patient.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient experienced head cold.  The outcome of the event was not reported.; Reporter's Comments: A 49-year-old, female patient experienced head cold, on an unspecified date after vaccination with INN Flu Vaccine Seasonal. The causality of the event was unassessable due to the lack of information regarding the vaccination date and onset latency of the event.
Myalgia Left arm pain and numbness Narrative:  Received 2nd vaccine on 1/27/21. He is experiencing numbness and  tingling down arm 1 week later, pain went to elbow now there is numbness and  tingling from the elbow down to the hand. Pain level is at 7/10 in pain scale. Exerting efforts and carrying coffee, mug makes it worse. Resting makes it better ." He never had any of this issues before. He denies any chest pain or any shortness  of breath or any cardiac issues associated with this. He is right hand dominant.  Has not seen any PCP yet. Was advised to follow up with PCP as he has hx of  HTN.  Other Relevant History:
Patient experienced flushing and burning of face ~45minutes after receiving the first dose of Pfizer vaccine. Patient returned to the clinic because of the symptoms. Patient notes having a similar reaction to prednisone.
Received MMR vaccine 04/08/02, developed joint pain 04/16/2002, increasing in intensity. Seen by doctor 04/24/02.
Feels nauseous all the time but not vomiting; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Feels nauseous all the time but not vomiting) and FATIGUE (Tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004020A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (Feels nauseous all the time but not vomiting) and FATIGUE (Tired). At the time of the report, NAUSEA (Feels nauseous all the time but not vomiting) and FATIGUE (Tired) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: TCR  was received on 04-May-2021: Outcome of events was updated as recovered/resolved, action taken was updated as n/a. It was reported that, no HCP care was sought by the patient.
Received 3rd booster 11/1/2021. Remember getting Bullae type rash on the left side of my neck and right buttock cheek between 11/6 and 11/11. Extremely itching esp with hot water showers.   It appears to look like contact dermatitis.   No new soaps or shampoos. No new laundry soap. No new fragrances.  No new foods or animals.  It appears to get better and worst.  It has migrated to also include right side of neck.  Have tried to OTC hydrocortisone cream, antifungal cream, triple antibiotic creams.  Not really improved. Having MD look at 1/18/2022.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as starting on or after 25-MAY-2016) unspecified number of patients were administered with improperly stored M-M-R II (lot # L012481, expiry date 10-APR-2017 and lot # L029266, expiry date 04-AUG-2017) (therapy type digital data logger) dosing details and route unknown. Concomitant medications were not reported. The administered vaccines were subjected to temperature excursion of 63.3 degree F for a time frame of 2 hours and 1 minute. It was reported that the vaccines administered were not subjected to previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Received Moderna booster on Dec 16. Felt arm soreness at injection site and fatigue for a couple of days. Only mild reaction. On Dec 26, noticed very itchy scalp and ears. Dec 27, broke out in hives all over body with intense itchy and warm skin. Skin has remained sensitive and itchy since then, managed a bit with antihistamines. Intense itchiness flairs up randomly in different regions of the body -- ears, wrists, elbows, palms, bottom of feet, etc. But skin all over often feels flushed and easily irritated. Any scratching leaves bright red streaks and can set off raised wheals. Any scratching creates intensified itchiness. I've also been suffering from intense bouts of heartburn. I have never experienced this or hives before. I do have seasonal allergies, but no known allergies to foods or medications. I'm now taking Pepcid AC at morning and night, as well as Zyrtec D every morning. Itchiness is most intense at night and early morning when 24 hour antihistamine is wearing off. Trying to manage histamine levels by avoiding high histamine foods.
4 Days following the second Moderna shot, I began to feel a tingling, mostly buzzing sensation in the area below my abdomen. The intensity was not very strong and would come and go. Now, several weeks later, the buzzing has intensified, is constant and has spread to my chest. Prior to receiving this does, I have never experienced this sort of sensation in my body.
11/20/2003 at HS left arm became sore and by 11/21/2003 patient was unable to lift left arm due to soreness, 11/22/2003 began experiencing dizziness and vomiting.  11/23/2003 vomiting resolved but dizziness worsened.  11/24/2003 dizziness began to resolve and by 11/25/2003 all symptoms resolved except left arm continued with minimal soreness.  Patient reported to Dr. but no treatment was done.
Information has been received from a health professional concerning a 12 month old female who on 13-APR-2007 was vaccinated with Proquad. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, VAQTA, and PREVNAR. On 27-APR-2007, the patient developed  rash from head to toe characterized as a "fine" and "raised" measles-like rash. At the time of this report the patient was recovering. Unspecified medical attention was sought. No other information was provided. No product quality complaint was involved. Additional information has been requested.  10/06/2007 This is in follow-up to report(s) previously submitted on 7/6/2007. Follow-up information received from a licensed professional nurse states that there is no change. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with (Oka/Merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lo #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow-up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (Oka/Merck) VARIVAX that was administered to a 12 months old patient on 21-AUG-2014: lot# J014228 and expiration date: 08-NOV-2015. This is one several reports received from the same source. Additional information has been requested.
SHORTNESS OF BREATH; FELT VERY TIRED; MUSCLE ACHES; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 74 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced shortness of breath. On 17-MAR-2021, the subject experienced felt very tired. On 17-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, headache, and fever on 17-MAR-2021, and had not recovered from felt very tired, and shortness of breath. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Swelling around the injection site; Redness around the injection site that is about 4 inches across; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site that is about 4 inches across) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site that is about 4 inches across). At the time of the report, VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site that is about 4 inches across) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Event outcome is updated. ( Not recovered (Ongoing) to Resolved).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
flu-like feeling; We both had major headaches; i had severe lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (i had severe lower back pain) and HEADACHE (We both had major headaches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like feeling) and HEADACHE (We both had major headaches). In December 2021, the patient experienced BACK PAIN (i had severe lower back pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) 12-Dec-2021 for Adverse event, at an unspecified dose and frequency. On 13-Dec-2021, INFLUENZA LIKE ILLNESS (flu-like feeling) and HEADACHE (We both had major headaches) had resolved. In December 2021, BACK PAIN (i had severe lower back pain) had resolved.            No concomitant medications was reported.   This case was linked to MOD-2021-415871 (Patient Link).
Left deltoid slightly swollen, warm to touch. Redness 4 x 4 1/2 inches. Per mother pt. scratching her arms. Ice pack applied & reminded mother to continue rubbing area & apply ice pack for 10-15 min every 2-3 hours to come back if no changes.
Pt recvd vax 27MAY92 lab eval in AUG92 neg for rubeola antibody; No further details were provided;
I experienced a strong headache, muscle aches, fatigue, nausea, and a low fever.  I treated it by taking Tylenol.  The symptoms were largely gone on the second day after the vaccination.
vaccine was moved from frozen storage to refrigerated storage; administered expired dose (6 days beyond use date); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired dose (6 days beyond use date)) and PRODUCT STORAGE ERROR (vaccine was moved from frozen storage to refrigerated storage) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired dose (6 days beyond use date)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was moved from frozen storage to refrigerated storage). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered expired dose (6 days beyond use date)) had resolved. At the time of the report, PRODUCT STORAGE ERROR (vaccine was moved from frozen storage to refrigerated storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received information included dose number and first dose information was updated. Patient demographics was added.