chrisvoncsefalvay/vaers-outcomes huggingface dataset:
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported
pt received  Covid19 vaccine  Pfizer Dose 1 on  04/22/21- no  adverse effects  Pt received Covid19 vaccine Moderna Dose 2 on 05/19/21 - no adverse effects
I started have a severe headache, diarrhea, and nausea. I went to urgent care and was diagnosed with migraines. I started vomiting and nonstop diarrhea. I missed about a month of work. My migraine is still ongoing as of today. It is there every day ever since I got the shot. I went to neurologist about this. They did blood work, normal results. I also had irregular bleeding and I went to OBGYN about this. They did an ultrasound. She thinks I am having a inflammatory response to the vaccine. All my doctors believe that these symptoms are due to the vaccine. My migraines are so bad, I cannot work a whole day off work. I also get magazine infusion now.
feel very itchy; hives on her chest and back, which is sporadic, that come and go ever since then; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (feel very itchy) and URTICARIA (hives on her chest and back, which is sporadic, that come and go ever since then) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for Birth control pill.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PRURITUS (feel very itchy) and URTICARIA (hives on her chest and back, which is sporadic, that come and go ever since then). The patient was treated with CORTISONE for Adverse event, at a dose of 1 dosage form; LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (feel very itchy) and URTICARIA (hives on her chest and back, which is sporadic, that come and go ever since then) outcome was unknown.            No medical history was reported  It was stated that the patient was 5'5 and a half tall and had no allergies. It was also reported that a week after the vaccination, the patient felt itchy and 2 days later to that had hives which stayed for about 5-10mins and were sporadic, also comes and goes ever since then. Regarding the treatment medication, the patient was given Benadryl which was shifted to or replaced with Zyrtec.   This case was linked to MOD-2022-461229 (Patient Link).
No Adverse Event; 1 expired dose was administered to a patient; First dose was administered on 19Oct2022 more than 36 days apart; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 expired dose was administered to a patient), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 19Oct2022 more than 36 days apart) and NO ADVERSE EVENT (No Adverse Event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 082B22A and 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Oct-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Dec-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 28-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 19Oct2022 more than 36 days apart). On 28-Dec-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 expired dose was administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 expired dose was administered to a patient), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 19Oct2022 more than 36 days apart) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 expired dose was administered to a patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 19Oct2022 more than 36 days apart).    No concomitant product reported by reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication reported by reporter.
On 11/14/2021 my ears started throbbing. I felt like I was getting an ear infection, so I went to see the Nurse Practitioner on 11/17/2021. She said my ears looked inflamed, but I did not have an ear infection. She gave me prednisone to take for 2.5 days. My ears then started to feel better after taking the medication. Since then, my ears will randomly start ringing. Yesterday my ears were ringing all day and today I feel fine.
red itchy and bumpy rash a week after the vaccine.   My menstruation is much heavier than ever before! It began on Monday and usually it is just heavy for one day. But for the first time, it has been consistently heavy for three days.
minimal injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 10:30 (Lot number: ER8727) at the age of 57 years as single dose for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing); "Chronic bronchitis" (ongoing); "Chronic obstructive pulmonary disease" (unspecified if ongoing); "GERD" (ongoing); "Gastroparesis" (unspecified if ongoing); "essential hypertension, benign" (ongoing); "Mixed hyperlipidemia" (ongoing); "Hypoxia" (ongoing); "obstructive sleep apnea" (ongoing); "Lymphedema" (ongoing); "Osteoarthritis" (ongoing); "Vitamin D deficiency" (ongoing); "smoker" (unspecified if ongoing); "low back pain" (ongoing), notes: she's been on pain medicine several years due to low back pain and she takes the pain medicine anywhere from every 4-6 hours. Concomitant medication(s) included: GUAIFENESIN (ongoing); BAYER BACK & BODY PAIN taken for pain. Vaccination history included: Shingrix vaccine, administration date: 25Jun2019, reaction(s): "really painful". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "minimal injection site pain".  Additional information: Hydrocodone/acetaminophen 7.5-325 mg 1 tablet by mouth 4 times a day as needed. She generally takes it every 4-6 hours. She also takes Bayer Back and Body Extra Strength to supplement her pain medicine, 500mg coated caplet she takes one every 6 hours, the medication in the Bayer back and body is aspirin 500mg and caffeine. She occasionally takes 2 if she's having extreme pain.   No follow-up attempts are possible. No further information is expected.
Pt. stated she developed cold ski, migraine, loss of coordination, sore throat, body aches, and irritated eye.
Patient had 99.9 temp and developed red, macular rash all over the body on 1/20/10. She is fussy. No other symptoms.
Rash; Tooth infection; was received in October of 2019 and has not received the second dose.; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, tooth infection and incomplete course of vaccination. On an unknown date, the outcome of the rash and tooth infection were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and tooth infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced tooth infection and rash, both of which have resolved. Limited information was available. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
I had a mammogram on 09/03/2021 and it detected some suspicious calcifications cells. On 09/10/2021 they did a close up mammogram. They recommended I come back for a biopsy on 09/21/2021. My doctor called me on 09/24/2021 and he diagnosed me with breast cancer  (Ductal Carcinoma in Situ). He scheduled me to see the surgeon on 10/01/2021 and I had surgery on 10/12/2021. Right now I am recovering. My follow up with the surgeon is on 10/28/2021.
Shaking uncontrollably; Some times have harder tremors in chest and back; Internal shaking that feels like sitting on a message chair set to level 5, its constant and all over body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 08:30 (Lot number: EW0161) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DEXAMETHASONE; MONTELUKAST; FLUTICASONE. Past drug history included: Erythromycin, reaction(s): "Drug allergy". The following information was reported: TREMOR (non-serious) with onset 13Apr2021 08:45, outcome "recovered" (13Apr2021), described as "Shaking uncontrollably"; TREMOR (non-serious) with onset 13Apr2021 08:45, outcome "not recovered", described as "Some times have harder tremors in chest and back"; NERVOUSNESS (non-serious) with onset 13Apr2021 08:45, outcome "not recovered", described as "Internal shaking that feels like sitting on a message chair set to level 5, its constant and all over body". The events "shaking uncontrollably", "some times have harder tremors in chest and back" and "internal shaking that feels like sitting on a message chair set to level 5, its constant and all over body" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor, tremor, nervousness.   Additional information: Onset date of event shaking uncontrollably was 13Apr2021 08:45. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The paramedics were called, they took her vitals, told her to monitor the shaking. The patient felt better, after at hour the visible shaking stopped, but the patient had an internal shaking that felt like she was sitting on a message chair set to level 5, it was constant and all over her body. The patient went to urgent care they gave her Benadryl, it did not help. It had been non-stop since the vaccine. Therapeutic measures were taken as a result of reported events and included treatment with Benadryl. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This report is for 2nd of 2 patients. This consumer reported for a male patient (Reporter husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient experienced sore arm on an unspecified date. Reported as, reporter and her husband had the Pfizer 2nd covid 19 vaccine, other than a sore arm, didn't have any other side effects. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Within 24 hrs after receiving ROTAVIRUS vaccine, pt. developed diarrhea, blood & mucous present at times for next 2 weeks.  Pt. was evaluated by physician.  Parent told that it was from ROTA vaccine.
17APR91 t103.4 @ 8AM; mom adm APAP x 48hrs; Pt also irritable, poor appetite; Examined by MD on 17APR91; MD noticed no cause for sx x/immun;
did not develop any (COVID-19) antibodies at all; Zydelig and Biontech COVID-19 vaccination interaction; did not develop any (COVID-19) antibodies at all; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021-0560094.  A 66 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation, prophylaxis; idelalisib (ZYDELIG) (Batch/Lot number: unknown) for chronic lymphocytic leukaemia. Relevant medical history included: "Chronic lymphocytic leukaemia" (ongoing), notes: Notes: Previously was a test person for Idelalisib. The patient's concomitant medications were not reported. The following information was reported: ANTIBODY TEST ABNORMAL (non-serious), ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown" and all described as "did not develop any (COVID-19) antibodies at all"; DRUG INTERACTION (non-serious), outcome "unknown", described as "Zydelig and Biontech COVID-19 vaccination interaction". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date, the patient's SARS CoV-2 antibody test was negative. This case manufacturer control number 2021-0560094.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness around injection site; Swelling around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness around injection site) and INJECTION SITE SWELLING (Swelling around injection site) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Redness around injection site) and INJECTION SITE SWELLING (Swelling around injection site). At the time of the report, INJECTION SITE ERYTHEMA (Redness around injection site) and INJECTION SITE SWELLING (Swelling around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: NNI confirmed
Slight tenderness at the injection site; Slight redness / at the injection site/2.5 inch slight redness; This case was reported by a consumer and described the occurrence of injection site tenderness in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site tenderness and injection site erythema were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in his left arm at the doctor's office and on 23rd December 2020 noticed a 2.5 inch slight redness and slight tenderness at the injection site.  The reporter felt the tenderness at the injection site when lays down on his side. The reporter did not consent to follow up.
On 4/04, muscle aches, fever, chills, vomiting.  0n 4/05, chills continue, dizziness, nausea.  Still dizziness on 04/09, time of submittal.
Spouse reports patient had, "spell with his eye" beginning on September 2nd, patient was having difficulty seeing and a decrease in his vision.  Medical care was sought on 9/7/21 from Dr. at Eye Clinic, patient had lost vision in that eye. Was sent to Medical Center for further testing. Patient and spouse were told that patient had experienced a "stroke in his left eye" causing vision loss that was not reversable.
pt recv vax & started w/inc fever 6hr later of 105;MD @ ER didn't know if it was a viral infect or from vax or stomach infect;
10/11/11 rash on chest, abdomen, back & under breasts rash was reported as warm, mildly pruritic reports chills, temp. 100.7, rash on back of neck advised to take antihistamine & f/u with PCP.
hives from head to toe; fall straight asleep; weakness in arms and legs; fatigue; chills; shortness of breath/difficulty breathing; loss of appetite; headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing) and DECREASED APPETITE (loss of appetite) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing), DECREASED APPETITE (loss of appetite), HEADACHE (headache), URTICARIA (hives from head to toe) and SOMNOLENCE (fall straight asleep). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (weakness in arms and legs), FATIGUE (fatigue), CHILLS (chills), DYSPNOEA (shortness of breath/difficulty breathing), DECREASED APPETITE (loss of appetite), HEADACHE (headache), URTICARIA (hives from head to toe) and SOMNOLENCE (fall straight asleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Patient reported severe itching to every part of the body above the knee and severe headache, which started around 4:00AM, the morning following vaccination. Headache improved after taking maximum strength Tylenol. Itching had improved some by the time patient came to the pharmacy (around 12:30PM) to report the incident, but was still bothering her. Recommended Benadryl to alleviate the itching.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-MAR-2016, an adult patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (exact dose, lot # and expiration date were not reported, intramuscular). This was the first dose in the series of three, and the patient received the appropriate adult second dose of RECOMBIVAX HB on 16-APR-2016. Additional information has been requested.
States could not sleep the night after receiving injection. Saw his primary MD who referred to a neurologist. Was c/o of pain in (L) arm radiating to chest area and shoulder area. Had MRI and ? nerve conduction studies were all negative. States he took steroid x 6 days with some improvement. Continue to have sharp "shooting pain" from elbow to chest area.
funny taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 10:30 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sensitive to medicine" (unspecified if ongoing); "MS" (unspecified if ongoing); "allergic to unspecified medicines" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 04Mar2021 11:00, outcome "recovered" (04Mar2021), described as "funny taste in mouth". Therapeutic measures were not taken as a result of dysgeusia. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins for an unknown indication. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 04Mar2021 at 11:00, the patient experienced funny taste in mouth for about 15-30 minutes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021322781 same product/event, different patient;US-PFIZER INC-2021322782 same product/event, different patient
PATIENT LEFT OFFICE AFTER VISIT. MOM RE-ENTERED OFFICE CARRYING PATIENT STATED PATIENT JUST HAD HER VACCINES AND CAN'T WALK. UPON ARRIVAL TO ROOM PATIENT WAS CONCIOUS, OXYGEN 97% RA, 49 HR, BP 90/50. PATIENT HAD BREAKFAST PRIOR TO APPOINTMENT. PATIENT STATES SHE FELT WEAK, WAS CLAMMY, AND PALE. AFTER MINUTES OF OBSERVATION, PATIENT'S VITAL SIGNS 99% RA, 97 HR, 82/62 BP, PATIENT ALERT, SITTING UP, STATES SHE FEELS BETTER, EATING CRACKERS AND DRINKING JUICS
very swollen lymph nodes in axilla area, very painful, took several days for swelling to go down