chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered 1ml to five patients; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1ml to five patients) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1ml to five patients). On 30-Mar-2021, ACCIDENTAL OVERDOSE (Administered 1ml to five patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-062261, MOD-2021-062169, MOD-2021-062219, MOD-2021-062188 (Patient Link).
12/21/2020: fatigue, muscle ache 12/22/2020: fatigue, muscle ache, headache, fever, loss of appetite, nausea, and sore throat.
Developed fever, headache, chills, myalgia about 6 hours after vaccine administered, nasal H1N1.
I developed hives and itchiness all over the body excluding my face. They lasted for 3 weeks. The hives lasted for 2 weeks. I had poison ivy level itchiness which caused it to be difficult to sleep. I saw my doctor around the 2nd week of January. She prescribed prednisone after I had taken BENADRYL all weekend and showered with SELSUN BLUE. The itching was so bad that I developed black and blue bruises on my legs, arms, and back. I had had a massage and thought that it could be the massage oil. I took the prednisone, and it didn't help. I was using more steroids and removed spicy foods from my diet. I was only able to wear very soft loose clothing. I was advised not to drink alcohol. I was on the prednisone for 10 days and I was advised not to do any activities that would cause me to sweat and irritate the rash. My knees were so painful I wanted to cry. I took oatmeal baths and psoriasis. I used eczema creams as well. It didn't go away until last week. All the symptoms subsided except for a little dry skin. I am still very tired as well.
64 yo female s/p 2nd dose of Moderna vaccine. Reports intermittent chest pain and chest pressure. Patient escorted into treatment area  and evaluated.  Clinical and site leads notified.  Initial v/s : O2Sat 98%, HR 88, BP left arm 178/95 Patient reports her bp is not usually elevated. 09:45am Vital signs: O2Sat 98%, HR 85, BP left arm 168/98 09:55 am Vital Signs: O2Sat 98%, HR 84, BP left arm 163/97 10:00 am Patient reports her symptoms are without improvement. EMS called. 10:10 am Vital Signs: O2Sat 99%, HR 84, BP left arm 160/91. Initially patient expressed financial concerns about going to the hospital with the EMS and said her son would take her to the hospital. EMS was already in route.  At approximately 10:15am EMS arrive on site and patient left with EMS.
GARDASIL vaccine administered 3 days prior to due menses. Patient with (+) pregnancy test on 6/24/08. Injection given on 6/11/08. LMP 5/13/08 - 3rd injection of series.
12/11/21 presents to EC ED for "Fall, confusion". PMHx of "CHF, alcohol abuse"
Information has been received from a Registered Nurse concerning to a patient (age and gender not reported) who on an unknown date was inadvertently vaccinated with an expired dose of VARIVAX (Lot No. K021485, exp. 03-NOV-2016) (site and route not reported) for prophylaxis. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Patient broke out in hives (urticaria multiforme) covering head, face, neck, front and back of torso, arms, hands, and legs
Per wife reporting over phone on Sunday: Patient began having muscle pain/aches (flu-like aches) and severe shivering Thursday night (day of vaccine) that continued into Friday and Saturday. Symptoms are improving and not getting worse. When wife ask patient today (Sunday) if he was feeling better patient thought it was improving. When asked if they had talked to a doctor yet they said no and we will be contacting the PCP on Monday to let them know about event incase follow up needed.
Anxiety, palpitations, vitals wnl. Given water and time to relax.
Chills; fatigue; Severe abdominal cramping; Gallbladder attack; This is a spontaneous report from a contactable consumer, patient.   A 73-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscularly in the left arm on 26Jan2021 at 03:30 AM (at the age of 73-years-old) as a single dose (Batch/Lot Number: EI9262), and received the second dose intramuscularly, in the left arm on 16Feb2021 (at the age of 73-years-old) as a single dose (Batch/Lot Number: EN6201), for COVID-19 immunisation .  Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included hydrochlorothiazide/ramipril (RAMIPRIL HCTZ).  About a week after both Covid-19 vaccine injections, the patient experienced chills, fatigue, severe abdominal cramping, and gallbladder attack. The patient stated that the chills and fatigue, were expected, but she had severe abdominal cramping and what appeared to be a gallbladder attack. The patient did not have a sore arm or fever. No treatment was received for the events. The patient recovered from the events, chills, fatigue, severe abdominal cramping, and gallbladder attack.
The patient reported immediately after the vaccine was administered that it stung. The pain in his shoulder and radiated from the shoulder into his chest and neck. That pain has subsided but his shoulder is very stiff and now swollen and red. He has never had a reaction to a vaccine like this before. This was reported to me 7.30.19.
Information has been received from a RN concerning a 30 year old female with no known allergies and a history of migraines who on 03/17/03 and 04/16/03 was vaccinated with the first and second doses of varicella virus vaccine live (Lot # 643533/0768M); 2nd dose (Lot # 643824/0870M). Concomitant medication included Zomig. It was also reported that the pt received an injection of Depoprovera on 03/17/03.  On 02/04/04, the pt had a negative titer. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.   Follow up information received from a registered nurse indicated that the patient had a failure to seroconvert to immune status. Lab tests for varicella zoster obtained on 01/08/2003 and 02/04/2004 showed that the patient was non immune. No further information is expected.
Patient given ENGERIX vaccine 6/13/14 40mcg IM. Stated experienced hives that PM on body. (Lot 3744L exp 5/7/16).
Pt stated she was feeling very anxious piror to vaccine. She has a hx of fainting with medical procedures. Last even was 2 years ago, 4 days post wisdom tooth extraction. She did not alert nurse of this history prior to vaccination.  After receiving vaccine she stood up and appearedto have vasovagal syncope as she stepped out of the vaccination booth. Nurse had her sit immediately. O2 sat was retrieved and applied mask at 4 liters. Transported to medical booth via wheelchair. Placed suspine on cot with legs elevated. Color returned quickly, and pt was talking, alert and oriented. Initial O2 sat- 86 but quickly increased to 98 on O2. O2 sat on room air fluctated 95-97 but increased when her mask was pulled away and deep breath taken. EMS assesed. Pt and mom declined transport and will f/u with physician.
sun poisoning; sunburn on hands and head; lymph, ears, hands swollen; lymph, ears, hands swollen; lymph, ears, hands swollen; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PHOTOSENSITIVITY REACTION (non-serious) with onset 21Mar2021, outcome "unknown", described as "sun poisoning"; SUNBURN (non-serious) with onset 21Mar2021, outcome "unknown", described as "sunburn on hands and head"; LYMPHADENOPATHY (non-serious), PERIPHERAL SWELLING (non-serious), EAR SWELLING (non-serious) all with onset 21Mar2021, outcome "unknown" and all described as "lymph, ears, hands swollen". The events "sun poisoning", "sunburn on hands and head", and "lymph, ears, hands swollen" were evaluated at the physician office visit.  Additional information: On Sunday, 21Mar2021, the patient was just outside for an hour to hour and a half. He had a long sleeve shirt on. He got sunburn on hands and head, and his hands got swollen. He went to the doctor on 23Mar2021, and he said he had sun poisoning. None of his medications have changed in 4 years. His doctor said it was probably an adverse event to the vaccine.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
His discomfort started about 10 days after 2nd vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (His discomfort started about 10 days after 2nd vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced DISCOMFORT (His discomfort started about 10 days after 2nd vaccine). At the time of the report, DISCOMFORT (His discomfort started about 10 days after 2nd vaccine) outcome was unknown.      No treatment information was provided. No relevant concomitant medications reported.
Since shot constant headache, double/blurred vision right eye, diagnosed as 3 Third Nerve Palsy by primary doctor and ophthalmologist.
About a month after the second dose of the Moderna vaccine, I developed pain in my metacarpophalengeal joints and my proximal phalanges. Its been about a year and the pain is quite persistent. When its bad, I use a heat pack or ice pack or put some arthricream rub.
Prior allergy to varicella vaccine; Swelling of the back of the throat, Nausea, Itching, BP 167/88 HR 78 RR 16; Administered Epi 0.3mg to Right Thigh and provided EMS transport to hospital
STROKE/ LEFT SIDE IMPAIRED; BLOOD CLOT ON BRAIN; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 22-SEP-2021, the patient was admitted to the hospital with a blood clot on brain causing a stroke which left patients' left side impaired. The number of days hospitalized was unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke/ left side impaired and blood clot on brain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210952881-COVID-19 VACCINE AD26.COV2.S-stroke/ left side impaired and blood clot . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
PATIENT RECEIVED MCW4 AND TDAP TODAY.  TDAP WAS GIVEN FIRST IN LEFT ARM, MCW4 SECOND IN RIGHT ARM.  PATIENT SAID IT IMMEDIATELY FELT WEIRD.  AFTER ADMINISTRATION, HE REJOINED MOTHER AND SAID HE STILL FELT WEIRD AND THAT HE FELT PRESSURE IN THIS THROAT AREA.  PATIENT TOLD MOTHER IT FELT PAIN-LIKE FROM THE ADMINISTRATION SITE TO THROAT.  ADVISED MOTHER TO HAVE PATIENT SIT FOR ABOUT 15 MINUTES TO MONITOR FOR ALLERGIC REACTIONS.  MOTHER ALSO CHECKED PATIENT'S PULSE.  I RECHECKED PATIENT AT 15 MINUTES AND HE SAID THAT HE FELT MOSTLY NORMAL AND THAT THE FEELING IN HIS THROAT WAS GONE.  TOTAL TIME WAS APPROXIMATELY 20 MINUTES.  PATIENT AND MOTHER LEFT TOGETHER.
still got sick very sick; Initial information received on 24-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who still got sick very sick after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (strength, dose, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site flu vaccination.  On an unknown date the patient diagnosed with a non-serious event of still got sick very sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported this case is received from Social media, The following potential adverse event has been found on a public post and I still got sick very sick.  No lab data was reported.  Action taken was unknown.  It was not reported if the patient received a corrective treatment for the event.  Outcome was Unknown.
This report describes the occurrence of spaciness in a 7 y.o. female who received Hep B vaccine recombinant (Engerix-B). This report was received from the subject's mother and had been verified by a physician. The subject had no relevant medical history, concurrent medical conditions,or concurrent medications. The subject experienced no adverse events following receipt of the 1st and 2nd injections of Engerix-B. The subject's mother reported that on 4/12/99, the same night after receiving the third injection of Engerix-B (lot #ENG2919A2), her daughter became "spacey" and "had problems with short term memory". Reportedly, per the mother, the symptoms have resolved with an unspecified sequelae. This subject's mother also stated that her daughter "is having problems with learning in school".
Pt resides at an facility, normally communicative and interactive. Received his second dose of the Moderna COVID-19 vaccine 2/15 and complained of a head ache after. The morning of 2/16 he was found to have a fever of 104.8, altered mental status, possible seizure like activity and taken to ED. ID consulted due to high fever, AMS, LP recommended to rule out meningitis. Due to the patient being on warfarin he needed to be reversed first which was done. The following day he was back to his baseline and afebrile. LP was canceled at that time.
Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had unknown past drug allergy.  The patient's past medical history included Cardiomyopathy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient was taking unknown other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received unknown COVID-19 Vaccine.  Company comment: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19 on unknown days after fourth dose of mRNA-1273 (Spikevax) vaccine. The patient had received four doses of mRNA-1273 (Spikevax), last being on 31-Mar-2022. The patient was treated with Nirmatrelvir, ritonavir (Paxlovid) from 13-May-2022 to 18-May-2022 for COVID-19. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19 on unknown days after fourth dose of mRNA-1273 (Spikevax) vaccine. The patient had received four doses of mRNA-1273 (Spikevax), last being on 31-Mar-2022. The patient was treated with Nirmatrelvir, ritonavir (Paxlovid) from 13-May-2022 to 18-May-2022 for COVID-19. Outcome of the event was resolving at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Swollen, red, raised rash. Appeared within 1-2 days of vaccine. BENADRYL cream improved rash. Reported adverse reaction to MD. Rash is resolving. BENADRYL cream has eased symptoms.
Itchy full body; rash; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female consumer reported for herself that: A 34-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration, administered in arm left on 12Mar2021 at 14:30 (at the age of 34-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included breast feeding. There were no known allergies. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medications included prenatal vitamin, oral birth control and oral antibiotics. Patient was not received any other vaccine four weeks prior vaccination. On 14Mar2021 at 07:00, the patient experienced itchy full body rash. Since vaccination patient not tested for covid-19. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts were possible, Information about lot/batch number could not be obtained.
This spontaneous report as received on 20-NOV-2014 from a pharmacist refers to a female patient of unknown age. On 03-NOV-2014 the patient was vaccinated with an expired dose ZOSTAVAX (lot # H016762, expiration date 11-DEC-2013), 0.65 ml, subcutaneous. No adverse experience was reported. No further information was provided. Additional information has been requested.
patient received vaccination on 5/22/19. She called on 6/7/19 reported pain in elbow, shoulder, sternum, below left breast, under arm, back, moderate pain & skin feeling sensitive to touch since 6/1/19. Few red bumps. No rash or redness in injection site.
shortness of breath; Low heart rate at 38 to 45; facial swelling; cough; low blood pressure 98/52 - 98/50; generalized weakness; This is a spontaneous report from a contactable other Healthcare professional (patient) reported for himself. A 57-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 57 years) as dose number unknown, single for COVID-19 immunization. The patient did not have any relevant medical history, concurrent conditions, relevant past drug history and known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jun2021 at 15:00 pm, the patient experienced low heart rate at 38 to 45, low blood pressure 98/52 - 98/50, generalized weakness, facial swelling, cough, shortness of breath. The patient was not hospitalized for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included blood pressure measurement: low (98/52 - 98/50) and heart rate: low (38 to 45) on 06Jun2021. The patient received treatment with Amoxicillin, Benadryl, bedrest and oral hydration. The device date was reported as 27Jun2021. The outcome of the events at the time of last observation was resolving.  Information about lot/batch number has been requested.
pt recvd vax;same day of dose,exp pain & numbness in lt arm;tx w/ anaprox & was taking Motrin as needed;pt reported that sxs were nearly completely resolved;does not have pain like before but some numbness in little finger;
BRUISE AT THE INJECTION SITE; SORE AT THE INJECTION SITE WHEN PUSHED; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-APR-2021, the subject experienced bruise at the injection site. On 26-APR-2021, the subject experienced sore when pushed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise at the injection site, and sore when pushed. This report was non-serious.