chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion of 48 degree Fahrenheit for 48 hours due to a possible refrigerator malfunction with no reported adverse event; Initial information received on 26-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 5 unknown age and unknown gender pediatric patients who were administered with IPV (vero) [IPOL] after the vaccine was exposed to a temperature excursion of 48 degree Fahrenheit for 48 hours due to a possible refrigerator malfunction with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect IPV (VERO) (lot T1E871M, expiry date: 10-Oct-2022; formulation, strength, dose, route not reported) for prophylactic immunization.  On an unknown date the patients were administered with IPV (vero) [IPOL] after the vaccine was exposed to a temperature excursion of 48 degree Fahrenheit for 48 hours due to a possible refrigerator malfunction with no reported adverse event (medication error).  It was reported "The Director called to report a temperature excursion involving one punctured IPOL and one sealed IPOL due to a possible refrigerator malfunction (not human error) and is requesting stability information. The condition was 48F for 48 hours. The unopened IPOL is supported by the extended stability data, however the punctured IPOL is not supported by the extended stability data. The caller confirmed that the punctured IPOL had been administered to 5 pediatric patients and will email back the safety information for those patients, as she did not have it available at the time of the call."  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Fatigue; Headache; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The patient described severe vomiting and diarrhea following H1N1 vax. The patient stated that she did not go to the ER or PCP. The states that she did have a hysterectomy on 12/9/09.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had not 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.   Concomitant product use was not provided by the reporter.  Treatment includes cold wash cloth and heating pad. The patient got vaccinated and got pain in the arm continuously since the day. When patient sits in his chair it doesn't bother him. Patient's pharmacist suggested he might be having ascites if the vaccine was given way up his arm and that might be reason for the pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a nurse practitioner concerning a 16 week old female infant with no known allergies or pertinent medical history who on an unspecified date was vaccinated orally with 2ml of ROTATEQ (lot # 660679/0407X). There was no concomitant medication. Subsequently, the week of 23-JUN-2008 the patient developed watery stools approximately 24 hours after vaccination. Medical attention was sought, the office was called. There were no lab studies performed. At the time of report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is one several reported from the same source. This is in follow-up to report (s) previously submitted on 7/15/2008. Follow-up information has been received from a nurse practioner concering this 17 week old previously reported as 14 week old female infant with no known allergies of pertinent medical history who on 23-Jun-2008 was vaccinated orally in the AM with a second dose of ROTATEQ (lot # 660596/0211X) (previously reported as lot # 660679/0407X). There was no illness at the time of vacciantion of any adverse events following prior vaccination with the patient or the patient's sibling. Subsequently, in the late PM on 23-Jun-2008 the patient started having 4 - 5 watery green stools daily for 5 - 6 days. There were no lab studies performed. At the time of the report, the patient recovered in 4- 5 days on approximately 27-Jun-2008. Additional information is not expected. This is one of several reports from the same source.
Case number PHEH2014US003846 is an initial spontaneous report received from a consumer on 24 Feb 2014: This report refers to a 16-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: Unknown) intramuscularly at a dose of 0.5 ml on an undetermined date. The vaccine was reported to be from the 2013/2014 season. No adverse event was reported following this administration error (inappropriate age at vaccine administration). Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 24 Feb 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
had a rash on neck, going up cheeks and on the back of neck; redness; itchy; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:00 (at the age of 48-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included Known allergies to Sulfa drugs. The concomitant medications/Other medications in two weeks included unspecified medication. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not covid tested post vaccination. It was reported that, the patient received first immunization Friday 05Mar2021, on Saturday 06Mar2021, the patient had a rash on neck, going up cheeks, and on the back of neck, red, itchy took Benadryl and used hydrocortisone cream, started becoming less on Monday did not switch soaps, perfumes, etc. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received the treatment for the events. The outcome of the events was recovering.  No follow-up attempts are possible:information about lot/batch number cannot been obtained.
Mild rash to arms per patient. No rash observed upon assessment. At 10:00 left facility.
CHILLS,BODY TREMORS,HEADACHE,RED FACE,HOT (NOT SURE IF FEVER), EYES HURT, DRY COUGH
This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seem at a physician office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl). At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.
Red sore arm, swelling, hot & very painful to the touch. Reaction started less than 24 hours after shot
Daptacel with short expiration dates (4 months out upon receipt)/no AE; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2019SA172657 and 2019SA172651.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and reported that Daptacel with short expiration dates (4 months out upon receipt)/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 17-Jun-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA and expiry date: 24-Apr-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if 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 holder's compliance with the requirements set out in Directive 2001/83/EC 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.
Headache, Sedation, Myalgia, Arthralgia, Fever, Chills, pain at the injection site Narrative:
patient called 5/4/23 and reported swollen lip. she was given 2nd dose shingles 5/1. when to doctor and was given steroid and seems to be helping-swelling decreased
Slight numbness in face.  Numbness would come and go lasting from 5 to 30 minutes.  Slight numbness under right eye; left part of lip; left cheek bone area; and lower right side by chin.  Numbness was not in all areas at the same time.
Itchy back/ stomach; Red face; This is a spontaneous report from a contactable pharmacist. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 25Apr2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had medical history. It was unknown whether the patient had known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient had concomitant medications. It was unknown whether the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. On 25Apr2021, the patient experienced itchy back and stomach, red face. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events itchy back and stomach, red face was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
anaphylaxis history - hands felt tingly and tight.  "Swelling"  Benadryl given iniitally bp and pulse up.  last vitals are 130/89; 71; 99% and 16 Symptoms improved
Patient claims she became ill and broke out into a rash from the high dose flu vaccine she received. It happened within a week of receiving the vaccine. She narrowed it down to 5 days after receiving the shot. Fever of 103.5 lasted 2 days with a sore throat. Patient still had a significant rash on arms, legs and torso. Measle like rash occurred.  She did not go to see a physician.
This spontaneous report as received from a nurse practitioner refers to a 22 year old male patient. The patient had none pertinent medical history. The patient as an infant received unspecified acellular pertussis vaccine and had a reaction of fever and lethargy. The nurse practitioner reported that, on an unspecified date a patient was administe5red a dose of (Oka/Merck) VARIVAX subcutaneous (dose, , lot # and expiration date were not provided) and, on 05-AUG-2014, a second dose of (Oka/Merck) VARIVAX subcutaneous (dose was not provided) (lot # J014960, expiration date: 26-NOV-2015). The reporter stated that, on 06-AUG-2014, the patient experienced a 5 centimeter in diameter, tender, knot and induration at the site of (Oka/Merck) VARIVAX administration in posterior left arm. There was no treatment given for adverse event and no lab diagnostic studies performed. The outcome of the events was reported as not recovered. The relatedness between the events and (Oka/Merck) VARIVAX was unknown. The patient sought medical attention at the office of nurse practitioner on 07-AUG-2014. Additional information has been requested.
I started having PVCs a few days after receiving my first dose. The PVCs have gotten worse. I have started seeing a Cardiologist in CardioVascular Specialist.
8/30/07 Day of physical, patient had throat erythematous - no sympt. 9/4/07 presents with runny nose, headache, mild sore throat, no fever. 9/8/07 Pain ankles and feet/swollen toes and rash, itchy chest/thighs. 9/10/07 Seen at office: rash maculopapular itchy generalized swollen ankles and legs, tenderness ankles and calves. RDT present. Rx Zyrtec.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, (lot #, expiration date, dose and route not reported) for shingles prevention. Pharmacist stated the patient experienced redness and tenderness at injection site on an unspecified date. It was unspecified if the patient had sought medical attention. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Severe itching for a few days pink  skin about as big as an ear of corn, upper arm somewhat swollen
Pt recv vax on 12/28/98; on 12/29/98 pt exp warm, red, swollen w/ itching; tx=Tylenol, Benadryl & warm soaks
Shoulder pain in the arm which was injected with the vaccine. The patient is still in pain.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed generalized chickenpox with about 1000 vesicles. Pt was treated with acyclovir.
excruciating pain @ vax site that spread down to arm & over shoulder; numbness & tingling in extremities; burning of vision & 2 episodes of violent tremors; shoulder pain; no sleep; neuritis; convuls ?, weakness of arm & leg, ringing in ear
Patient approached clinic and stated she needed her first Pfizer vaccine dose. Appropriate paperwork filled out with patient and visit completed per protocol. After injection while educating patient to wait on site she verbalized she did well with her other vaccines. When asked for clarification she admitted that she had had two doses of Moderna already but came today because her doctor told her to go get her first Pfizer dose. I then confirmed with patient that this was in fact not her first dose of COVID vaccine and she did not meet the qualifications outlined by the CDC for a third booster dose. Educated on what to monitor for but patient did well in her post vaccine 15 minute wait.
only the liquid portion was administered; only the liquid portion was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On 03-APR-2023, the patient received Menveo. On 03-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: only the liquid portion was administered) and inappropriate preparation of medication (Verbatim: only the liquid portion was administered). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 04-APR-2023 Nurse called to report only the liquid portion of Menveo was administered by mistake to a patient, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up via email.
I had the 2nd dose on 03/29/2021. First day I had a sore throat with a clear runny nose. Second day, no sore throat but continued runny rose, sneezing and temperature of 100.5. Third day though 6-7 day, still had runny nose, sneezing, tired, slight dry cough, normal temperature. Never had a fever again. From day 5 on I started with a post nasal drip. As of today, July 2nd I have an occasional sneeze or post nasal drip that is improved. I was exposed to some people who had traveled in the week before and they came back with a cold, they tested for COVID and were all negative but I believe I got my cold virus from them. On Friday 06/25/2021 I took my elderly mother to urgent care for a fall and while there I told the nurse practitioner of my symptoms and she checked me out and pretty much said I looked ok but recommended the COVID test as a precaution, which was negative. She checked my ears, nose, throat, lungs and glands and everything was normal. She recommended Flonase.
Itchy; Red patchy area; Headache; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), PAIN IN EXTREMITY (Right arm sore), ERYTHEMA (Red patchy area) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 023M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Right arm sore) and HEADACHE (Headache). On 19-Feb-2021, the patient experienced PRURITUS (Itchy) and ERYTHEMA (Red patchy area). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, PAIN IN EXTREMITY (Right arm sore) had resolved. At the time of the report, PRURITUS (Itchy), ERYTHEMA (Red patchy area) and HEADACHE (Headache) had resolved.            Patient is taking medication for Cholestrol   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received  contains significant information ; outcome of the events updated
Erythema multiforme starting 10 days post vaccine administration. No fever or respiratory symptoms. Rash covered trunk, abdomen, back, neck, face, all 4 extremities, hands and feet. Currently receiving prednisolone taper.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer Vaccine on 04/07/2021 and 05/05/2021. Presented to ED 1/18/22 c/o SOB, generalized weakness w/cough x4days. CT chest w/multifocal alveolar ground glass attenuation suggesting inflammation 2/2 to atypical PNA w/chronic left pleural effusion, pleural thickening, atelectasis, and scarring. Lactate of 2.7. Initial Covid test neg on 1/18, Covid test + on 1/24, steroids increased. Intubated 2/9/22, 2/2 worsening metabolic acidosis and resp distress. Developed sudden worsening of hypotension w/PEA arrest. Tx'd w/micafungin, solumedrol, remdesivir, baricitinib, vanc & zosyn. Transitioned to DNAR, expired 2/9/22.
Approx 3 minutes after receiving vaccinations patient complained of nausea, began spitting clear saliva into basin, complained of hearing loss. Nausea resolved in approx 4-5 min without emesis, patient reported hearing was back to normal. Pt also reported that she had some visual blurriness at the same time as the hearing loss. All had resolved and patient felt shakey but better. BP 124/94, skin warm and dry. Pt sat in office under observation for 25-30 min and left with mother. Pt reported feeling okay when leaving.
9.5x12cm erythema and induration, hot to touch and she states it is painful. This reaction is in her R distal thigh.
Case number PHEH2012US014310 is an initial spontaneous report received from a healthcare professional on 17 Jul 2012 with a follow-up received on 20 Aug 2012: This case refers to a 10-year-old female patient. She was given only Men C,Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M11047), intramuscularly without being reconstituted with Men A component on 16 Jun 2012. No adverse reaction was reported following this administration error. Reporter stated that the family chose not to have the Men A portion of MENVEO administered to the patient. They decided to wait and get the booster dose of meningococcal vaccine since they were not going out of the country. There was no adverse event and patient is doing good. Follow-up received from the health care professional on 20 Aug 2012: Updated information about booster dose of vaccine.