chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 14 SEP 2004 from a registered pharmacist concerning a 16 month old female who "about week ago" was vaccinated with MMR.  Subsequently the patient developed a temperature of 100 deg F, a rash on her chest, and a large red spot at the injection site.  Hospitalization was not required.  Topical hydrocortisone and oral tylenol were prescribed. No product quality complain involved.  Additional information was requested.
MODERNA COVID VACCINE #3 GIVEN 10/20/21, LOT #076C21A; patient lives in local Health Care Center; he had a positive COVID test on 4/19/22 and passed away in the facility on 4/21/22.
Red swollen area on arm measured 8 inches long by 3.5 inches wide.  Also fatigue.
Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other) and NO ADVERSE EVENT (No adverse event) in a 91-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient received two bivalent Moderna Covid-19 vaccines within 2 weeks of each other).    No concomitant medications was reported. No treatment drug details was reported.
Information has been received from a certified medical assistant concerning an adult male who "recently" was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (lot 651319/ 1007P).  Subsequently the patient developed injection site pain, redness and swelling. The patient sought medical attention and was treated with ADVIL.  Subsequently, the patient recovered.  Additional information has been requested.
Information has been received from a Physician's Assistant concerning a female who was vaccinated IM with Gardasil and within 24 hours developed a rash. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a Physician's Assistant concerning a female who was vaccinated IM with a dose of GARDASIL and within 24 hours developed a rash. The patient's outcome was not reported. Additional information is not available.
Case number PHEH2015Us017360, is an initial spontaneous report received from a nurse on 02 Sep 2015. This report refers to a 36 years old male patient. Past medical history and concomitant medications was not reported. He was vaccinated with two doses of FLUVIRIN (batch number: 1514501) intramuscularly on the same visit on 02 Sep 2015. No adverse event was reported following the administration error.
felt sick; tooth infection; Product dose omission issue; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (felt sick), TOOTH INFECTION (tooth infection) and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick), TOOTH INFECTION (tooth infection) and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) ongoing since an unknown date for Tooth infection, at a dose of 1 dosage form. At the time of the report, MALAISE (felt sick) and TOOTH INFECTION (tooth infection) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission issue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information were reported by the reporter
5 min after short lips tingling moved to chin and nose. Within 25 minutes my entire face was tingling. Within  30 minutes my thighs were numb on the top only. Similar reaction when I gave platelets. My face tingling lasted 5 hours. My thighs lasted 12 hours
Shortness of breath, can't breathe deep. Saw my doctor 3 weeks later and had 2 x-rays found nothing. Had same problem prior 2 flu shots that only last 5hrs each time. This time it won't go away.
Patient received Pfizer vaccine instead of getting the 2nd dose of Moderna vaccine. Mistake was discovered about 15 minutes after the vaccine was given. Counseled patient on vaccine, and that they should still have an immune response.
4-10 and 4-11-2021 Complained of headache; 4-12-2021 Sister-in-law stopped by around 5pm and noticed facial drooping on left side. My brother took her to a stand alone ER,  She was given a CT Scan and nothing was seen on the CT Scan. Asked  her to do various actions and was diagnosed with Bell's Palsy.  It was recommended for her to go to a hospital ER or follow up with primary doctor for an MRI.  4-13-2021 Early AM lost her balance and fell down. Complained of legs cramping. Lost strength on leftside of body especially hand and legs. Appointment with primary doctor made for next day. 4-14-2021 Had 11 am appointment with primary care doctor who scheduled an MRI for 1:20pm.  Sent to hospital ER following a positive result for an ischemic stroke in frontal lobe. Evaluated at hospital ER around 3:15pm.  Admitted into hospital ER at 7:33pm.
I have never skipped/missed s period or been more than 2 days late . I am now a week late with my period.
Post vaccination, pt. complaints of L arm pain and numbness, light headedness. VS 108/72, o2 sat at 97% on RA, HR 76. Pt. alert and oriented, with her husband @1139 patient complained of LA and LL numbness and mild itchiness of the injection site.  At 11:58 patient said she feels better and is ready to leave the facility, very mild numbness on the left arm. Health teachings provided with emphasis on following up to their PCP for evaluation or calling 911 PRN.  Released with Husband.
Patient complained of abdominal pain within several minutes after receiving injection; Patient began to experience anaphylactic shock and collapsed. Epinephrine was administered and swelling began to go down while 911 was called. EMS arrived and patient left the pharmacy with paramedics several minutes later
Rash on scalp, forehead, back and armpits; This is a spontaneous report from a contactable consumer (patient). A 54-years-old male patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: Ex06130121) via an unspecified route of administration on 15Mar2021 at 12:00 (at the age of 54-years-old) in left arm as dose 1, single for covid-19 immunisation. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, he was not diagnosed with COVID-19. Since the vaccination, He had not been tested for COVID-19. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced rash on scalp, forehead, back and armpits on 01Apr2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. He did not provided information regarding the reported adverse event with the use of the product. Therapeutic measures were taken, and the patient was treated with topical lotion. The patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot Number: EP7533) via unspecified route of administration in arm left on 05Apr2021 at 12:00pm as single for covid-19 immunisation. Device date was reported as 24May2021. The outcome of event was not resolved.  Follow-up attempts are completed. No further information is expected.
Excessive drowsiness for approx 5 hrs p/immun w/DTP/OPV/HBOC; no fever or other sx; not reported to provider until 2 mo later;
SORE ARM; EXTREMELY COLD AND COULDN'T GET WARM FOR ABOUT TWO AND  HALF HOURS; This spontaneous report received from a patient concerned a 63 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included: severe latex allergy and drug allergy (lidocaine). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 202A21A, and expiry: 21-SEP-2021) dose was not reported, on left arm (dose number in series was 1) administered on 09-APR-2021 around 15:00 for prophylactic vaccination. On 10-APR-2021, About 12 hours later, around 2:00, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced freezing for a good hour/extremely cold feeling/couldn't get warm for about two and half hours. She was awake for that hour, then it went away and she went back to sleep. On 12-APR-2021 (on day 4 from primary shot), the patient experienced sore arm (dose number in series was 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, on right arm (dose number in series was 2), 01 total, administered on 18-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-DEC-2021, about 36 hours after the booster shot, the patient experienced extremely cold and could not get warm for about two and half hours. On 21-DEC-2021, her arm got sore on day 4 from the booster (dose number in series was 2). She had extremely mild side effects, exactly same symptoms that happened after the first shot (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extremely cold and couldn't get warm for about two and half hours on DEC-2021, and had not recovered from sore arm (dose number in series was 2), This report was non-serious. This case, involving the same patient is linked to 20211235748 (dose number in series was 1).
Patients left arm was red, slightly swollen, hot 2 days after shots were given left arm.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 04-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # K004204, expiry date 12-JAN-2017) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Period has been heavier and longer lasting two weeks at a time. My period has always been consistent and changed about a month after the second dose of Pfizer.
Feeling of slight numbness of left side where injection was given-Diarrhea started about 45 mnts after vaccine - numbness of lower extremities for a few seconds that has happened on two different occasions, late afternoon same day of vaccine and a few weeks after - dizzy/off balance like feeling of the head that is still ongoing but not as frequent - joint pain day of vaccine with body chills, hot flashes, body aches, exhausted, headache that was frequent after vaccine day, fever
Local redness - induration, pain 5 x 6 cm. Treating with ice, DURICEF - ADVIL close monitoring. Improving with care.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a syringe of 0.5 ml FLUZONE QUADRIVALENT (lot UJ041AA and Exp. Date 30 JUN 2019) which was cracked by where the bar code would be and vaccine squirted from the side while a seven years old male patient was receiving vaccine. The patients medical history and concomitant medications were not reported. It is an actual medication error case due to vaccine underdose. Also it was a case of syringe issue. It was reported that, the syringe was cracked by where the bar code would be. as she was administering the vaccine, the vaccine squirted from the side she is unsure if the consumer received any or just part of the vaccine. No information reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Follow up information received from Nurse on 11-Oct-2018. Events added. List of documents held by sender: none.
Pt had sudden onset of projectile vomiting starting at 8 PM and lasting for 2 hours and then developed diarrhea x 2 the next morning.
Vomiting, Diarrhea, Lethargy, Anorexia, Disturbance in social behavior. This case was reported by a consumer and described the occurrence of vomiting in a 9 month old male patient who received diptheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The reporting consumer is the patient's mother. A physician or other health care professional has not verified this report. On 23 February 2004 the patient received the first dose of Pediarix administered in the right leg. The consumer noted that the patient had received two previous vaccinations with the components of Pediarix, but administered as individual components rather than the combined vaccine. Each of the two previous immunizations were administered in the patient's left leg. The day after receiving Pediarix vaccination, on 24 February 2004, the patient experienced vomiting, diarrhea, lethargy and lack of appetite. The mother consulted the patient's physician and Pedialyte was initiated. The consumer stated that her son was "not himself" and wanted to be held "all the time". The events were unresolved at the time of reporting.
Injectiosn site red, raised, itchy, non tender, with some excoriation about 3.5x4 cm with central hard nodule about 1/2 cm. No pustule.
This spontaneous report was received from a currently 70 year old male nurse who is also the patient with drug reaction/allergies (mild rash) to BACTRIM DS. In 1985, the patient was vaccinated with hepatitis b vaccine (manufacturer unknown). Dose, lot number and expiration date were not reported. In 1995, ten years later, the patient received another dose of hepatitis b vaccine (manufacturer unknown). The patient reported that his titer (first titer) was drawn and result was too low and he received another series of RECOMBIVAX 10mcg/1.0ml (on an unknown date). After completing the series with RECOMBIVAX, second titer was drawn again and at that time, level was adequate and he was told that he was "protected". However, about another 10 years after repeat doses with RECOMBIVAX, another titer (third titer) was drawn for unspecified reason, and the result came back low again (on an unknown date). Nurse did not received any additional hepatitis B series after titer testing. The outcome of his titer was drawn and result was too low/result came back low again was unknown. The patient sought medical attention. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a 16 month old female patient without any pertinent medical history and drug reactions/allergies. The patient was vaccinated subcutaneously with the first dose of 0.5 ml VARIVAX (Lot# reported as 0495AE) on 16-JUL-2012. Other suspect therapies included the first dose of M-M-R II (lot # reported as 0426AE) 0.5ml subcutaneously on the same day. The patient developed chickenpox lesions "48 to 72 hours after vaccination", which was on approximately 18-JUL-2012. The patient had an office visit on 20-JUL-2012 regarding the lesions. The patient returned to the office again on 24-JUL-2012 because the patient had a cough and low-grade fever. A throat culture was done and the patient was diagnosed with strep throat. Unspecified treatments were given for the AE. At the time of reporting, the patient was not recovered. Additional information has been requested.
Very red rash developed on 11-10-11 within 48-72 hours if receiving the vaccines. The rash was from head to toe. We sent her on to a dermatologist the same day. He felt it certainly possible from vaccines. Only treatment needed was BENADRYL at HS. Rash was gone by 11-22-11. Mother stated her stomach feels not as smooth no marks.
Pt right arm red, swollen, painful, also feeling nauseous. Advised to take BENADRYL Q4-6 hours, ice, rest.
pt devel an upper resp infect 2 to 3 hrs p/receiving flu vax;
Still got Covid; This case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The patient had the shots and still got Covid and patient stated was not in any pain and he/she asked what pain r u talking about. Additional supportive information: The follow-up would not possible as no contact details were available. Note: It was unaclear patient received Covid vaccine or not as said still got Covid so, as per page suspect coded as Shingle vaccine.
Started on 9/27/15 with left forearm swelling. Had mild fever. Calor and rubor of left forearm. Did improve 9/28/15. Seen in office 9/28/15.
Unable to get the 2nd dose due to snowstorm and due to visa issues; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose due to snowstorm and due to visa issues) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose due to snowstorm and due to visa issues). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the 2nd dose due to snowstorm and due to visa issues) had resolved.            No treatment medications were reported.
I received it last Wednesday at noon. By that afternoon my arm was marked by a super painful three-inch circle of hot, bright red. I was overcome by great fatigue and spent the day resting. During the night I started shaking to the point that my teeth chattered, and I had a terrible headache and great nausea. I called my doctor on Thursday and she sent me to the ER or an Urgent Care center; I chose Urgent Care. They gave me Zofran and Advil and ice for the arm and said I was having a severe allergic reaction to the vaccine. The doctor at the Urgent Care said to have the second shot anyway, in two to six months. But the doctor who gave me the shot, said next time could be even worse and she would NOT administer a second shot. Today is six days post-vaccine, and I am just starting to feel normal, but my arm still hurts and I'm still feeling kind of queasy and tired and weird. The headache is finally gone, as of yesterday. Do you have an opinion on getting the second shot? Without it I don't get the preventive benefit of the vaccine. With it I likely will get this sick or sicker.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 120 hours. The highest recorded temperature was 34 F (1.111111111). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
barely move her arm; felt sick; extreme chills; low grade fever; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (barely move her arm), ILLNESS (felt sick), CHILLS (extreme chills), PYREXIA (low grade fever) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 19-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 LIMB DISCOMFORT (barely move her arm), ILLNESS (felt sick), CHILLS (extreme chills), PYREXIA (low grade fever), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, LIMB DISCOMFORT (barely move her arm), ILLNESS (felt sick), CHILLS (extreme chills), PYREXIA (low grade fever), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Nov-2020, SARS-CoV-2 test positive: positive (Positive) mild symptoms, low fever, dry cough, headache, and loss of smell/taste.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product were not provided.  Treatment medication were not reported.
Medicine for IBS was working wonderfully for three months. A few days later I descended again into having the worst IBS flare ups ( worse than pre-meds). I've had a myriad of gastrointestinal issues since along with extreme fatigue that developed days afterward.