chrisvoncsefalvay/vaers-outcomes huggingface dataset:
armpit pain; hurts to put her arm by her side; swelling; itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hurts to put her arm by her side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (hurts to put her arm by her side). At the time of the report, PAIN IN EXTREMITY (hurts to put her arm by her side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. No concomitant medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to US-MODERNATX, INC.-MOD-2021-002594 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded US-MODERNATX, INC.-MOD-2021-002594:
Injections given 12/3/08 at 12n, mom noticed that he was scratching his left arm as soon as he left the clinic.  Due to history of ezcema, mom didn't pay attention to his arm.  when they were out at yogurt place on 12/5/08 at 4p looked at arm, swollen and felt warm to touch.  edema below site of injection, mid upper arm to elbow.  no signs of infection.  plan cool compresses and oral bendryl
Coughed to the point of throwing up; encrediably sore; could barely move; sick; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via socian media.  This case involves patient (unknown demographics) who experienced sick (illness), coughed to the point of throwing up (cough), encrediably sore (pain) and could barely move (hypokinesia), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (within 2 hours) following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a non-serious coughed to the point of throwing up (cough), encrediably sore (pain) and could barely move (hypokinesia), (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that last one patient had made me sick within 2 hours. To the point patient was considering going to the emergency room. Sick for 3 days. Coughed to the point of throwing up and was so encrediably sore pateint could barely move. Even my doctor told me patient should not get them.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Reddish,itching rash on legs; Itching rash on legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Reddish,itching rash on legs) and RASH PRURITIC (Itching rash on legs) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037 and 040B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE, FOLIC ACID and MONTELUKAST for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced RASH ERYTHEMATOUS (Reddish,itching rash on legs) and RASH PRURITIC (Itching rash on legs). The patient was treated with CORTISONE on 10-Jun-2021 for Itchy rash, at a dose of UNK dosage form. At the time of the report, RASH ERYTHEMATOUS (Reddish,itching rash on legs) and RASH PRURITIC (Itching rash on legs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose Number:4; Pfizer, Dose Number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 as dose 2, single (Lot number: EIV62508), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 065K21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 13Mar2018. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Moderna, Dose Number:4; Pfizer, Dose Number 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid start date: 07Dec2022, stop date: 11Dec2022 for COVID 19 treatment. Patient received other medication in 2 weeks product: Lisinopril and start date was 13Mar2018. Patient had no known allergies. Had Paxlovid after getting Covid; rebound infection quite harsh.
no adverse event; patient received improperly stored vaccine; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 13-DEC-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), 1 dose, lot # U024221, expiration date reported as 04-OCT-2023, but upon internal validation established as 04-AUG-2023 (dose number and exact route of administration were not provided) for prophylaxis (Product storage error). The vaccine had been improperly stored in the temperature of 39.55 Fahrenheit degrees (F) for 10 hours with no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse events were reported.
This initial spontaneous report was received from an internet news article and social media blog and refers to a male patient of unknown age. The patient's mother is an attorney. On 12-SEP-2016, the mother took her son for a doctor's appointment due to a backache (he had been hiking and tripped). During the appointment, she was informed that her son was due for his vaccination for human papillomavirus (HPV). So the patient received the HPV vaccine (manufacturer not provided) that day (dose, route and lot # not provided). Not long after, the patient was unconscious and unresponsive on the floor. The mother said that one moment, he was standing there. Then he passed out, tumbling backwards without using his hands to break his fall. His head slammed full force onto the floor, which was like concrete. Within an hour, the patient's family learned that he suffered a severe skull fracture from the fall. And within weeks, they learned that the boy was now deaf in his right ear because of  the trauma he experienced when his head hit the ground. The mother stated her son was still distraught a year later. The mother retained a local lawyer to pursue medical malpractice against the facility where her son was vaccinated as she was not informed of the possible side effects and he was not observed after the vaccination. The attendants were also not prepared when he fainted. Soon after the vaccination, they left to have an x-ray taken for his backache, where he collapsed. They would also seek judgments arguing that the vaccine caused her son to faint and suffer permanent disability. The mother stated that her son was never going to be able to listen to music the same way again and had constant ringing in his ears. They asked a specialist he if would ever regain hearing in the right ear and were told "it would be one in a million chance". The events deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive/vaccine caused her son to faint were considered disabling.     Upon internal review, deaf in his right ear, skull fracture, and passed out/unconscious/unresponsive /vaccine caused her son to faint were considered medically significant. Additional information is not expected.
Pt very upset crying & screaming-not wanting a shot, parents holding pt recvd shots & became listless, skin warm & dry, pulse reg, quit screaming & crying; nodded head to questions, watched approx 30-45mins;
Pt vaccinated on 12/14/07, reported itching begining 12/18/07 with the formation of a 3/4" x 3" hard red area at the site of injection. Daughter, who is an RN, says it is not a cellulitis, but is just a dry area with no flaking or scaling and a little warm to the touch.
Temp 37.1C; pulse 72, wt. 34.6 kg; SpO2 96%; area of mild swelling and erythema on the left thigh around the site of vaccine approx 8 cm in circumference. Distal sensation/pulses intact. Range of motion intact hip and knee. Mother reported fever x 2 greater than 100.4 at home, giving Ibuprofen. Mother reported fever up to 105. No signs of anaphylaxis, diffuse, rash, itching, or respiratory distress. Afebrile in clinic.
OEDEMA PERIPHERAL. Information has been received on 19-may-2003 from a licensed practical nurse concerning a male dialysis patient who was vaccinated with a first dose of hepatitis b virus vaccine rHBsAg (yeast). Subsequently the patient's "arm became swollen." It was noted that "no further injections were administered to the patient." The patient sought unspecified medical attention.
parents state that pt had temp of 106;next AM p/vax given pt taken to ER w/ temp of 102.5;520AM on 22APR97 treated w/APAP & sent home;
Patient had a round large ring with slight redness in the center. It looked like a large ringworm,  after research we believe it was an immune response to the vaccine, called "Granuloma Annulare".  Her doctor initially gave a steroid cream with no results then gave her an antifungal, clotrimazole.  The treatment is really to let it clear on its own. It is related to immune response, this condition can be caused by bug bits, excessive sun, stress or vaccine. The patient is doing fine with not harm to except the rash. I rececked with the patient and rash is starting to go away.
Caller stated that he received his second Moderna vaccine on 4/25/2021 and on the same day he developed tonsillitis and is not improving. Member denies any other symptoms at this time.
Forty five minutes after my shot I suddenly got metal mouth . Metal mouth lasted for more than a week . I also was nauseous. I also was very thirsty.
other zoster related injuries; shingles; Information has been received from a lawyer regarding a case in litigation and  refers to a patient of unknown age and gender. Pt's concurrent conditions, medical history and concomitant therapy were not reported. Pt was inoculated with zoster vaccine live (ZOSTAVAX)  on or about 24-OCT-2010, as prescribed and/or administered by a healthcare provider at a health center for the long-term prevention of herpes zoster or shingles. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider at the health center for shingles and other zoster related injuries. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The outcome of the events was reported as not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
high pitched screams, LOC, brain swelling, convuls, anemia; excessive sleepiness; intercrainial bleed; resp distress;
FATIGUE, SHORTNESS OF BREATH, DIFFICULT BREATHING, MYCOCARDITIS, RAPID HEART RATE , STARTED 5 DAYS POST VACCINATION, SEVERE FATIGUE AND CONTINUE FOR 3 MOS BLOOD WORK, EKG, HEART SCANS,   WORE HEART MONITOR, NORMAL UNTIL STRESS TEST PERFORMED IN JUNE. NO PRIOR HX OF DM, HYPERTENSION, OR HEART ISSUES UNITL AFTER 2ND VACCINE. HAD EMERGENCY ANGIOGRAM AND STENT PLACED DUE TO BLOCKAGE AN D CARDIAC REHAB WAS ORDERED . NEVER TOOK OR NEEDED ROUTINE MEDS PRIOR TO 06/2021
Patient reported nausea, injection site pain, redness, swollen, hot to touch within hours of receiving PPSV23 injection. Sx resolved next day.
Extreme chills and rigors for greater than 1 hour followed by profuse sweating. Rxn occurred aprox. 36 hours after vaccination. General malaise for next 24 hours after rxn. T not taken during rxn secondary fear of breaking glass thermometer.
Right arm, where vaccine was given was red and swollen, up into the shoulder area. Warmth, edema, and redness noted. Treatment: Applied cool compress to affected area.  Instucted mom to give Tylenol/or ibuprofen.  If no improvement, to see MD or ER immediately.
eyesight got fuzzy in the distance; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (eyesight got fuzzy in the distance) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN, METOPROLOL, CHLORTHALIDONE and Hormone replacement for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (eyesight got fuzzy in the distance). At the time of the report, VISION BLURRED (eyesight got fuzzy in the distance) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment reported.   This case was linked to MOD-2021-081586 (Patient Link).
Firm inflamed circle around injection site. Swollen and painful. Approximately 4 inches.
On left leg: Three inch diameter, red, hot and hard lump. My child had difficulty walking with his left leg and appeared to drag leg on 2/6 & 2/7. Hard 3 inch lump is still present and discolored. He was also in pain and crying most of the weekend. I contacted the doctors office and they asked me to bring my child in. He will be evaluated this afternoon.
I received the vaccine and about 5 days later I began experiencing flu like symptoms. My symptoms were fever, headache,  fatigue and sore throat.
Vomiting, diarrhea, weakness, paleness, no appetite, bruising, tenderness at site, drowsiness, unresponsive and bleeding at the injection site up to 30 minutes after administered.
Vaccine administered to 16 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 16 year old) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 16 year old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines reported.  No treatment information were reported.   Reporter did not allow further contact
Red nonitchy spot around the injection site, the size about 6 inches. The knot that developed in my arm the day following my injection was the size of a golf ball for three days. The injection spot was closer to my shoulder than middle of my arm. The red spot it slightly larger currently.
No signs or symptoms present. Medical Assistant asked patients mother to confirm name of patient and mother agreed. Medical Assistant administered shots to patient and when a different patient with the same name required shots at the same time, medical assistant noticed the wrong two shots were given to the patient.
Muscle pain; swelling; This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unspecified day the patient received 1st dose wth no reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced muscle pain and swelling. On an unknown date, the outcome of the muscle pain and swelling were unknown.   It was unknown if the reporter considered the muscle pain and swelling to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced muscle pain and swelling during 3 months after vaccination. The reporter consented to follow up.
Confusion, anxiety and panic. Lasted about an hour. Since that day I constantly have mental issues followed with slight anxiety and panic that are brief.
Shingles outbreak. Rash developed and increased in severity. 1/20/21 patient visited urgent care and was diagnosed with Shingles. Patient is a healthy 32 year old male with no recent history of immunosuppression or predisposition to shingles outbreak.
First day following vaccine date, pt felt nauseous. Injection site looked normal, and the other side of her arm was swollen by the size of an egg. The swelling was hard and warm at touch. Second day following the vaccine date, swelling went down, but was still ovbious. The whole upper arm became red. Patient felt better, but was still tired and not her normal self. Third day following vaccine date, swelling went down; redness almost went away, and patient felt great and normal again.
5 days later devel vomiting, some loose stools required IV fluids on third day lasted for 6 days;
had injection site pain for 3 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient was vaccinated with Shingrix in her right deltoid muscle and had injection site pain for 3 days and then it was resolved. The reporter consented to follow up.
At approximately 11 days post booster vaccination I broke out into itchy hives all over my body and have never had this before. Now 22 days later I still have hives and chronic uticaria all over my body. I am on daily zyrtec. The skin rash and lines on skin show up and then disappear throughout the day in all places including face. I was put on prednisone for 5 days and that did not help at all. Issue persists and was not an issue until after the booster shot. Never had a rash or eczema or hives in my life
had a COVID-19 action and was sent to the hospital; not feeling well; fell backwards; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (hospitalization), outcome "unknown", described as "had a COVID-19 action and was sent to the hospital"; MALAISE (hospitalization), outcome "unknown", described as "not feeling well"; FALL (hospitalization), outcome "unknown", described as "fell backwards". Clinical course: The reporter stated that his son's male coworker received the first dose of the "purple cap" Pfizer COVID-19 vaccine but did not receive the second dose.  On a date not provided by the reporter, the same above male coworker was rubbing his head and stated that he was not feeling well then fell backwards.  The reporter's son's workplace stated that the above male coworker had a "COVID-19 action" and was sent to the hospital and was still there per the reporter (at the time of the initial report).  The reporter stated, "the side effects of the purple cap Pfizer COVID-19 vaccine can kill you."  The lot number for bnt162b2 was not provided and will be requested during follow up.
At about 8:00PM the night I got the vaccine, I started having intense stomach pain and my head was pounding. I eventually threw up, and then I began experiencing chills and shivering while sweating. In total, I have thrown up around 7 times and I still have chills and a headache. I also have a sore throat and am extremely dehydrated. I can?t keep any food or medicine down and this is going on 24 hours straight with these symptoms.
Patient was seen in the ER 1 day post vaccination for redness and swelling at the injection site. He was diagnosed with cellulitis at the injection site and prescribed Keflex 500mg Q12hrs for 8 days.
Pt experienced 4-10 lesions on his trunk and leg and itching. Follow-up information indicated that they were mosquito bites.
very sore arm then fever following day night ( mild 99.1) fatigue 2 and 1/2 daya
Information has been received from a nurse referring to a patient of unknown age and gender. On 01-JUN-2015, the patient was administered with improperly stored dose of MMR II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
vaccine dose was given after the expiration date of 9/30/22 but before the extended stability date of 10/19/22
Erythematous Maculopapular rash appreciated in the L2-L3 distribution of the R leg. Largest patch 6cm in diameter. DX shingles. TX Acyclovier 300mg QID X 5 days.