chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received second dose  at day 21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose  at day 21) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose  at day 21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose  at day 21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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 provided.   This case was linked to MOD-2021-249914 (Patient Link).
Arm soreness/tenderness; A spontaneous report  was received from a 73-year old female patient who received mRNA-1273 vaccine and experienced soreness in arm/pain extremity.  No medical history and No relevant concomitant medications were provided by the reporter.  On 03 Feb 2021, prior to the onset of events, the patient received their dose of two planned doses of mRNA-1273 (Batch number unknown) via intramuscular route for prophylaxis of COVID-19 infection.   On 16 Feb 2021, patient experienced arm soreness/tenderness. No treatment medication was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was unknown at the time of this report.
uncontrollable diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (uncontrollable diarrhea) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 012620A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes, SIMVASTATIN, LISINOPRIL, COLECALCIFEROL (VITAMIN D3 1000) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced DIARRHOEA (uncontrollable diarrhea). At the time of the report, DIARRHOEA (uncontrollable diarrhea) outcome was unknown.            Three days after the booster shot, on Thursday night patient 2 developed uncontrollable diarrhea. On Friday Patient went to the ER and got tested for several things and the only thing the ER HCPs recommended is that Patient 2 stop taking their Diabetes medicine, metformin.  No Treatment informations were reported.
HEART POUNDING, ANXIETY  Narrative:  Patient felt heart pounding a few minutes after 1st Pfizer covid vaccine. VS: BP 148/90,P99, PO2 95& at 10:22. Symptoms subsided after 10 minutes. Repeat VS at 10:33 BP 147/89. P 87, PO2 100%. Probably anxiety. Released with instructions to seek care at Ed or PCP if symptoms recur.
HCP really shook and administered the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ERROR (HCP really shook and administered the vaccine) in a 69-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (HCP really shook and administered the vaccine). At the time of the report, PRODUCT PREPARATION ERROR (HCP really shook and administered the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided
very strong heart pounding which was constant/like it was trying to be out of my chest, heart is beating like this, sensation of really heart pounding; Echo found mitral valve prolapse; This is a spontaneous report from a Pfizer sponsored marketing program Pfizer RX Pathways. A contactable 39-year-old female consumer (patient herself) received first dose of bnt162b2 (BNT162B2, solution for injection, batch/lot number Lot:ER8737), via an unspecified route in left arm on 06Apr2021, dose 1, single (age at vaccination time 39-year-old) as single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medications included (Xanax) ALPRAZOLAM (start date: she did not know over the past 10 years and she was taking for Anxiety).On an unspecified date in Apr2021 patient experienced a very strong heart pounding, which was constant. BP and HR were both normal. It got less severe after about 5 days. However, she had a dull constant heart pounding ever since. Echo found mitral valve prolapse (never been seen or heard before), and she read that some medications can cause valve issues. Still awaiting further test results. The patient eats healthy, exercises regularly. No prior health issues. The patient had the first shot and had the other usual normal problem there but then a day or two day after her heart started pounding like really hard like it was trying to be out of my chest but it wasn't like my heart beat wasn't elevated and her Blood Pressure wasn't elevate everything was normal. So just a sensation of really heart pounding and that lasted for, she wanted to say may be five days and then what else, since then she still have the heart pounding feeling but a lot less, so it's really mild but is still constantly there. Most of her test were fine but Echocardiogram showed a Mitral valve prolapse which she never had before and now she got some, she did not know if the causing factor if it just triggered it but now, she was still working with the cardiologist to figure out why her heart was so beating like this. The patient had a regular blood test like full CBC then I also had additional test for cardiologist, went for full blood test and that was all normal.The outcome for both events was unknown.  No follow-up attempts are possible. No further information is expected.
Initially reached for something and felt sharp shooting pain about 3 hrs after flu shot; felt tingling right hand, right leg, right side of face; inner lip, nose and right eye became swollen around 7 pm. Took Benadryl; 30 minutes later, tingling went away; 2 hrs after taking Benadryl, swelling decreased. There were no body aches.
On day of injection experienced fever, chills, joint paint 12 hours after injection and for 24 hours. Joint pain continued into Monday and then redness began in arm 2" below the injection site. By Tuesday the arm was swollen and angry with the redness area increasing.. By Wednesday it was significantly hot and the area had continued to increase. I sought medical attention. Measurements were taken and I returned for follow up on Friday. On Friday my blood pressure was high (I do not have a history of high blood pressure) and I was running a low fever. My arm was still angry, sore and swollen. I was placed on antibiotics  in case it was cellulitis given blood pressure medication and requested to monitor blood pressure.. By Friday evening, my right side of face was tingling my redness in arm was less and blood pressure was coming down. Over weekend, arm continued to lessen in area and redness. However, started waking with left sided headache and increased blood pressure (158/110) which decreased over course of day back to normal by early evening. Returned Monday for follow up. My arm was pink but significantly less angry, blood pressure still up in a.m. Next morning awoke with left headache, raised blood pressure and red rash up shoulder and neck area. Returned for medical visit Wednesday. Arm marbeled like and still sore to apply deep pressure, left side of face deep tingling and blood pressure 164/114 at Dr visit at 6:40 a.m. Continue with follow up visit tomorrow to run labs.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 5 hours. On 04-JAN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
When injecting the vaccine into the patient's right arm, the needle and syringe disconnected, leading to a good amount of the vaccine splashing outside. Because of this and deciding that lower-than-authorized dose was administered (and most likely less than half of the dose), the vaccine was given again on the left arm of the patient.
Dose 1: sore arm.  Dose 2: sore arm, fever, chills, aches, headache, fatigue, nausea, diarrhea, turned beet red on evening 2 during shower  Dose 3: sore arm, fever, chills, shaking, aches, headache, fatigue, tiredness, nausea, vomiting, diarrhea, slight stomach pain, itchy rash, numbness on lip, dizziness
Pt recv vax on 12/29/98; on 1/3/99 pt exp limp LA, non usage of LA, left hand&wrist pain; tx=Motrin; pt seen by orthopedist to rule out synovitis
Increase Tinnitus by 50% after second shot. Muscle spasms in arm, shoulder and neck. Migraine.
itchy rash,pink; mildly sore arm; my legs/arms and face are itchy; Fever; headache; aches; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash,pink), PAIN IN EXTREMITY (mildly sore arm), PRURITUS (my legs/arms and face are itchy), PYREXIA (Fever) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 RASH PRURITIC (itchy rash,pink), PAIN IN EXTREMITY (mildly sore arm), PRURITUS (my legs/arms and face are itchy), PYREXIA (Fever), HEADACHE (headache), MYALGIA (aches), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, RASH PRURITIC (itchy rash,pink), PAIN IN EXTREMITY (mildly sore arm), PRURITUS (my legs/arms and face are itchy), PYREXIA (Fever), HEADACHE (headache), MYALGIA (aches), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information not provided. Concomitant medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060418 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060418:dose 2 (crosslink)
Batch of hives that similar but slightly different reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Batch of hives that similar but slightly different reaction) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Batch of hives that similar but slightly different reaction). At the time of the report, URTICARIA (Batch of hives that similar but slightly different reaction) outcome was unknown.            No Concomitant Medications were provided by the reporter. The patient experienced the adverse event 3 to 4 weeks after the second shot. No Treatment medications were provided by the reporter.       Reporter did not allow further contact
pt woke up from nap w/scanty rash & T103.5-gen sz w/loss of consciousness;taken to ER via ambulance;generalized febrile sz;
Extreme soreness in arm (I kind of think he may have administered it a little high on my shoulder so that it made my shoulder joint sore).  Fatigue, low grade fever, general malaise similar to a mild flu.  Lasted 24 hours, with another 24 hours feeling "hung over" as though recovering from a viral infection.
no adverse event; a patient received an expired dose of PNEUMOVAX; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, medical history, drug allergy/reaction was not reported.  On 18-DEC-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose number, route, anatomical location was not reported) lot # N023651, expiration date: 20-MAY-2019 for prophylaxis (expired product administered). No known adverse effects were reported. No product quality complaint was involved.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced inflammation and went to the emergency room (ER) and took prednisone on an unspecified date. The patient recovered from the event on an unknown date. Information on batch number has been requested. Sender's Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of patient demographics, medical history, concomitant medications, concurrent illness and event details description including time lag between the onset of the event and vaccination date of PREVENAR 13 and location of the inflammation. A possible causal association between administration of PREVNAR 13 and the onset of the event might not be fully excluded, assuming a plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Some diarrhea; Blister at injection site; slight burning sensation; This is a spontaneous report from a contactable consumer (patient). A 32-years-old patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 15Jul2021 11:00 AM (at the age of 32-years-old) at single dose for covid-19 immunisation. The patient medical history included allergy to Amoxycillin, covid-19, both from an unspecified date. The patient was diagnosed with COVID-19 prior to vaccination. The patient concomitant medication was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the Left arm on 24Jun2021 12:00 AM (at the age of 32-years-old) at single dose for covid-19 immunisation. On 16Jul2021 03:00 AM, the patient experienced Blister at injection site, slight burning sensation still as of 7/18 (18Jul2021), some diarrhea, unsure if related. No treatment was received for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
post-vaccination menstrual irregularities, including vaginal haemorrhages. experiencing heavy bleeding since the vaccine.
pt fell asleep around 12noon @ 1220 had episode of stiffening up & arching back; no fever noted; pt was able to be roused, remained listless & unwilling to eat rest of day; seen that afternon by MD dx sz;
8/20 Diarrhea, abdominal pain, fatigue, sore throat, panic (vaccine given 7/31/2007).
BODY ACHES; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and headache on 08-APR-2021. This report was non-serious.
Fever up to 102.5, loose stools x 2 d. Some congestion. Pertinent negs no abd pain, chest pain, coughing, ear pain, headaches, nausea, muscle aches, rash, sleepiness, vomiting, wheezing.
Itching 45min after injection. Progressive worse full body rash, stomach upset acid stomach nausea.
Information has been received from a physician concerning a 9 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Within the last 6 months", the patient developed a breakthrough case of varicella. Unspecified medical attention was sought. Treatment included either ibuprofen (Motrin) or acetaminophen (Tylenol). No laboratory diagnostic tests were performed. There was no product quality complaint involved. Additional information has been requested.
Soreness of the arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of the arm) and RASH (Rash) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included Colon cancer (Presently clear.). Concomitant products included INSULIN (NOVOLIN 30R [INSULIN]), CLOPIDOGREL BISULFATE (PLAVIX), PIOGLITAZONE, LISINOPRIL, ATENOLOL, AMLODIPINE BESYLATE, POTASSIUM CHLORIDE, FUROSEMIDE and ALLOPURINOL for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness of the arm) and RASH (Rash). At the time of the report, MYALGIA (Soreness of the arm) and RASH (Rash) outcome was unknown.            No treatment medication was provided.  Action taken with the drug in response to events was not applicable.
Information has been received from a physician concerning a 17 week old male with a history of hospitalization for meningitis and bronchiolitis who on 2/25/02 was "accidently" vaccinated with pneumococcal vaccine 23 polyvalent. On 2/25/02 the pt was also vaccinated with diphtheria toxoid/pertussis vaccine/tetanus toxoid, poliovirus vaccine inactivated and HIB conjugate vaccine (manuf unk). On 2/25/02 the pt's mother reported that he was awake during the night and was being fussy. On 2/25/02 the pt's ear was reported as negative. However, the pt was prescribed amoxicillin 250/5ml, one teaspoon, twice daily for 10 days for a possible ear infection. On 2/26/02 the pt was seen again and remained fussy, afebrile and screaming with his left ear slightly pink. It was reported that the child previously had meningitis and was hospitalized on 12/8/01 and seen in the office for follow-up on 12/13/01. It was also reported that the child previously had brionchiolitis and was RSV negative. Additional info has been requested.
Within 24 hours of receiving Pfizer vaccine dose #1 at another facility patient developed pleuritic CP, SOB, irregular heart rate and wheezing with chills.   Pain described as sharp, under left breast.
On 6/17/08, an hour after injection, patient experienced generalized pruritis and flushing and metal taste.  Was seen by health center doctor, given Zyrtec, offered Prednisone, declined Prednisone.  Referred to ER if worse.  Patient states on 6/18/08 had malaise and 102 fever, took Ibuprofen, did not see MD.
A literature report was received on 03/24/2003 concerning a 69 year old female vaccinee who experienced redness, discomfort, and blurred vision i the left eye approximately two weeks after  receiving influenza vaccine (brand unspecified) on approximately 10/01/1994. The vaccinee was part of a retrospective study to investigate the possibility that influenza vaccination  is a cause of recurrent uveitis in patients with a history of pre-existing ocular inflammatory disease. The vaccinee has a history of left  cataract removal by phacoemulisification in 1993, with post operative complications of iritis and vitritis which resolved by July 1994. The vaccinee never experienced and side effects with vaccinations. On 10/15/1994 the vaccinee presented complaining of redness, discomfort, and decreased vision in the left eye. Examination revealed a visual acuity of 6/12(20/40), 1+ cellular anterior chamber reaction, pseudophatic precipitates but no keratic precipitates and an intraocular pressure of 20 mm Hg. Fundus biomicroscopy revealed recurrent macular edema. The vaccinee was treated with prednisone acetate 1% daily every 1-2 hours for several days with a gradual decrease in dosage. The vaccinee reported that she treated herself for approximately 1 week, discontinued and then resumed the drops for several more days. Six weeks later she returned for examination, her eye had returned to normal Her visual acuity was 6/6(20/20) OS, slit lamp exam showed no uveitis, and intraocular pressure was 20 mm Hg. She had experienced no further disturbance since that time. The author concluded that influenza vaccination may act as a non specific stimulius of the immune system and theryby, reactivate uveitis. The exposure to influenza vaccine triggered recurrence of occular inflammation. Update1. 05/06/2003: A follow up report was received from a health care professional indicating that the vaccinee had recovered without sequalae, Cross Reference with: PJP200300141, PJP200300146, PJP200300143.