chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 62-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. The suspect vaccine FLUCELVAX QIV underwent temperature excursion for about 30 minutes and lowest temperature was 34.7-degrees F (out of recommended range). On 29-Nov-2017, the patient was administered with FLUCELVAX QIV which underwent temperature excursion (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events (incorrect product storage and drug administration error) as non-serious. Case correction received with IRD 07-Dec-2017: Added classification as "special case with no AE" in the general tab. Updated expiry date of suspect vaccine as 30-Jun-2018 (in the product tab). The narrative was amended accordingly.
Patient given first dose of Moderna Covid-19 vaccine series. Patient is under age of recommendation for administration. No adverse reactions noted after vaccination.
This spontaneous report as received from a registered nurse refers to an unknown age female patient with unspecified medical history or concurrent conditions. On 01-DEC-2004, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route and lot # were not reported). On 28-JUL-2011, the patient was possibly vaccinated with the second dose of VARIVAX (Merck) (dose, route and lot # were not reported) and in approximately May 2015, reported as "last week", the patient was vaccinated with a third dose of VARIVAX (Merck) (dose, route and lot # were not reported). Concomitant therapy was not reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
ATE A TINY PIECE OF CHEESE AFTER TAKING FOURTH DOSE; This case (PVX2019-2221) was received from a consumer on 29-Aug-2019. It described a 31-year-old adult male consumer who "ate a tiny piece of cheese after taking fourth dose" (PT: Product administration error), while being on Vivotif for an unknown indication.  Case report: The consumer took the first and the fourth dose of Vivotif on 23-Aug-2019 and 29-Aug-2019, respectively. But accidentally, he had a tiny piece of cheese after half an hour of taking the fourth dose.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "ate a tiny piece of cheese after taking fourth dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate a tiny piece of cheese after taking fourth dose" was considered as not applicable.
Information has been received from a nurse concerning a 17 year old female with no pertinent medical history and a penicillin allergy who on 12-JUN-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of Gardasil (lot #657737/0522U).  The patient was concomitantly vaccinated with MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown).  On 12-JUN-2007, post vaccination, the patient fainted in the office and was caught by her father before she fell to the floor.  The patient woke up on her own and went home.  On a unspecified date the patient was vaccinated intramuscularly (site not reported) with the 2nd dose of Gardasil (lot #657868/0523U).  When the patient received the 2nd dose of Gardasil she fainted again in the office.  The patient also had blisters around injection site.  The patient did receive unspecified medical attention, no diagnostic labs were performed.  At the time of this report the patient had recovered.  The patient did not receive the 3rd dose of Gardasil.  Additional information has been requested. 04/07/2008 Initial and follow up information has been received from a nurse concerning a 17 year old female student with no pertinent medical history and a penicillin allergy who on 12-JUN-2007 was vaccinated intramuscularly (site not reported) with the 1st dose of GARDASIL (lot#657737/0522U). The patient was concomitantly vaccinated with MENACTRA and DTaP (manufacturer unknown). On 12-JUN-2007, post vaccination, the patient fainted in the office and was caught by her father before she fell to the floor. The patient woke up on her own and went home. In follow up it was reported that on 23-AUG-2007, the patient received her second dose of GARDASIL intramuscularly into left deltoid (lot#657868/0523U). On 23-AUG-2007 when the patient received the 2nd dose of GARDASIL she fainted again in the office and it was reported that she also had blisters around injection site. The patient did receive unspecified medical attention, no diagnostic labs were performed. At the time of this report the patient had recovered. The patient did not receive the 3rd dose of GARDASIL. Additional information is not expected.
Red, warm rash at site of injection. Bigger than 1 inch. Itching with a little pain. Started 1 day after injection was given (3/26/15) BENADRYL and Hydrocortisone crm recommended pt did not buy it.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with a dose RECOMBIVAX (lot# H017018, expiration date: 11-JUL-2015, dose, units, route of administration, anatomical location were not reported) that were improperly stored. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Onset of polyarthralgia 2 wks p/first Hep B vax; involved bilat knees, ankles & feet x 1 mo;
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 48 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I was diagnosed with Bell's Palsy on 2/2/21 after I noticed muscle weakness on the right side of my face. Went to Hospital ED per Dr. and was diagnosed after stroke was ruled out. The facial weakness progressed over the next couple of days, and I was unable to move any muscles on the right side of my face. I started recovering on 2/11/21, and have regained some movement back in my face. It currently feels like I have about 10% of my muscle movement back.  I did take a five day course of Prednisone 60mg daily, which was started on 2/3/21.
patient's wife called 3 days after vaccine to report patinet's arm was warm to the touch and painful. Counseled to seek medical evaluation and possible treatment. Son is an MD and started patient on antibiotics for possible cellulitis. Called patient 2 days after reported event- states his arm is much better and he is feeling just fine.
This spontaneous report as received from a Licensed Practical Nurse refers to a 62 year old female patient. The patient's medical history included left mastectomy. On 06-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot number J007211, expiration date; 20-SEP-2014) 0.65 ml, subcutaneous in the right arm for routine vaccination, she also received PNEUMOVAX 23 (Lot number J009827, expiration date: 10-AUG-2014) intramuscularly in the right arm in the same vaccination session in error. The patient was suppose to receive a dose of ADACEL (manufacturer unknown) along with the ZOSTAVAX but she was given PNEUMOVAX 23 in error. At the time of this report, the patient had no demonstrated or reported any adverse effects. Follow up information has been received from a nurse practitioner reported that the 62 year old female patient was vaccinated intramuscularly (IM)/deltoid with the second dose of ADACEL (manufacturer sanofi pasteur) (lot # C4496AA, exp. date not reported) on 09-DEC-2013 at 16:48. Additional information is not expected.
10 minutes after receiving HPV, pt. had tonic clonic seizure twice in 15 minutes apart, last for 5-10 seconds.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 3-year-old male patient who received RABAVERT (batch number 5840118, expiry date 31st December 2018). On 20th October 2017, the patient received the 1st dose of RABAVERT (intramuscular) 1 ml. On 20th October 2017, 2 hrs after receiving RABAVERT, the patient experienced fever (serious criteria other: as per reporter), malaise and fatigue. The patient was treated with MOTRIN. On 21st October 2017, the outcome of the fever, malaise and fatigue were recovered/resolved. The reporter considered the fever, malaise and fatigue to be possibly related to RABAVERT. Additional details were reported as follows: The patient received RABAVERT around 1 pm on right thigh and the patient's mother told that, the patient started experiencing events in the afternoon. At 10 pm when the reporter spoke to the mother, the patient's body temperature was 103.1 degree F. The mother was advised to give the patient MOTRIN around the clock. The next morning, the patients symptoms resolved and no longer had a fever. The healthcare professional was not sure if this was due to the vaccine but stated that the patient had no other symptoms, no allergies, no cough or congestion so could likely be due to the vaccine as the child was otherwise healthy.
Expired Ipol was administered to pediatric patient, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (GMI) (Reference number- 00779244) and transmitted to Sanofi on 21-Sep-2021.  This case involves a four-year-old female patient to whom an expired IPV (VERO) [IPOL] was administered (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On 21-Sep-2021, the patient received a dose (0.5ml) of suspect IPV (VERO) (lot number: R1D972M; expiry date: 17-Jul-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported "IPOL was administered to a pediatric patient on 21SEP2021 (caller did not have demographics on patient) and the product expired on 17JUL2021"  The caller wanted to know the information on re-administration and possible adverse effects to look out for.  No adverse events were reported at the time of this report.  The outcome of the event was reported as 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 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.
Pain, swelling, nausea, fever,  chills, body aches, and chest tightness
Patient reported he woke up at about 5 am. He was having some dizziness and nausea symptoms. He remembers sitting on his bed and then waking up at the Infirmary. Medical staff reported he was drowsy and slow to respond. Denied any recent illness, chest pain, heart palpitations, or shortness of breath. Pt was placed on O2 upon arrival at the Infirmary. Hospital Neurology completed a workup, ECG was also completed. Recommended to follow through with a cardiac workup. Pt was cleared and returned to this afternoon.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Received immun 7/21/14 at 14:30. 1 hr later pain developed. Then noted redness developed, redness, swelling of the arm distal to the shot and now 36 hrs into this, redness spread to entire upper arm.
Patient complained of fatigue and stiffness, also reported having a fever. Injection site was red, raised and hot to the touch. Patient advised to take Ibuprofen OTC 2 PO TOD, PRN. As of 9/10/14. No fever still achy and fatigue.
Pt was vaccinated on 03/18/2002 at about 5pm. The next morning at 8am, the pt felt sick, had fever, nausea, blurred vision, felt very shakey like her nerves are hyper. She later saw her personal physician.
Severe pain in kidneys, hamstring pain, dizziness, pain in sinus area.  Weird feeling in head.
Noticed 05/07/02 that left arm, red, swollen and hard. Swelling to shoulder. Had to cut sleeve on shirt to get it off. Applied cool clothes and gave Benadryl. Itching started and scratch 05/08/02. Checked with school nurse and was told allergic reaction. Had two shots in that arm. Plans to take to doctor's today. To call with outcome of visit. Started on Cepzil and Benadryl. Swelling and redness gone by 05/10/02.Went back to school 05/13/02 still on antibiotics.
Pt states had more swelling of arm than normal, but no fever. Stomach cramps and sore arm. Saw Dr. 12-13 for unrelated prob & he was not concerned.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male patient between the ages of 19-24 years patient who experienced other anaphylactic shock, NEC (Serious, since 24-Nov-2011, until 24-Nov-2011) while enrolled in a study. Treatment medications included azithromycin (250mg, 2 tabs weekly for 6 weeks, oral) started on 16-Nov-2011 and stopped on 15-Dec-2011, indication unknown; epinephrine (0.3mg, injection, frequency and indication unknown) started on 24-Nov-2011 and stopped on 07-Dec-2011; prednisone (unknown frequency, dose, units, indication) started on 24-Nov-2011 and stopped on 24-Nov-2011; ZANTAC (unknown frequency, dose, units, indication) started on 24-Nov-2011 and stopped on 24-Nov-2011. Adverse events within 42 days of vaccination: Allergic reaction started on 01-Dec-2011, treated at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity and seriousness were not assessed, outcome unknown, resolution date 01-Dec-2011; anaphylaxis follow up on 14-Dec-2011, at outpatient visit, treatments medications included non-drug treatment medication included prescription and OTC, severity, seriousness and outcome were not assessed, resolution date 14-Dec-2011. At the time of the report the outcome of the AEs were: Other anaphylactic shock, NEC: recovered/resolved. The medical history of the patient no alcohol or tobacco use within 30 days prior to Adenovirus vaccination. The patient's concomitant medication included Azithromycin (Tablet, Oral, since 16-Nov-2011, until 15-Dec-2011, 2 tabs weekly x 6 weeks, IPV, Diphtheria-tetanus-pertussis vaccine, Influenza vaccine, Meningococcal vaccine. The patient's past medication were unspecified. Action taken with suspect drug: Adenovirus vaccine - Not applicable. Lab tests 07-Dec-2011, Aero allergies-normal, 07-Dec-2011, Apple Ab IgE-normal, 07-Dec-2011, Pumpkin Ab IgE-normal, 07-Dec-2011, Tryptase-normal, 07-Dec-2011, Pulmonary function test-abnormal early obstructive pulmonary impairment. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This event was assessed as "unknown" in severity. The medical monitor has assessed the causal relationship of the event as not related to the adenovirus vaccine.
Hurt more than normal with the injection. Noted hard spot when took BANDAID off when got home same day. Turned red in past 2 days and hard spot same size. May have been flatter before.
Anaphylactic symptoms - paleness, dizziness, itchy lips, face, mouth, throat, hives, tachycardia, hypotension. Parametics called.  Treatment - IV benadryl, famotidine, solu-medrol Improvement of symptoms, they did return later that evening, lessening in severity, and were treated with oral benadryl.
Muscle soreness, no redness, painful when lifts weighted stuff. Has used TYLENOL for discomfort started joint after received injection. States is getting better slowly. Back in dr 11-5-13. Bruising on arm now.
Patient states she woke up the morning after vaccine (5/3/18) with flu like symptoms, and her arm was in severe pain, at injection site, shoulder and under the arm. Patient states she was in bed for 2 days, then made an appt with her PCP Dr. about these ailments. Dr. referred her to the orthopedic physician for X-rays. Patient states Dr. found arthritis and a slight bone spur unrelated to the injection. Patient was then referred to physical therapy and is continuing that.
This spontaneous report as received from a physician assistant refers to a male patient of unknown age. The physician assistant reported that patient possibly received his second dose of GARDASIL late. The patient was vaccinated with a first dose of GARDASIL (Lot #, dose, route unspecified) on 26-OCT-2011, although the dose was ordered on that day, there was no documentation that was administered and the patient's mother said he did not received GARDASIL that day. A dose of GARDASIL (0.5ml, Lot#, route unspecified) was administered on 05-NOV-2012. This dose might be a second or first dose. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Severe soreness, bump in right arm pit, feeling very lethargic, pain in back, out of breath
Headache, nausea, abdominal cramping,  elevated blood pressure, 5 mins after vaccination.   At home the above symptoms continue plus joint pain, lower back pain, chills for 3 days.
SM had a normal reaction to Smallpox vaccine, with additional chest wall pain about the pectoralis major muscle group as well as the axillary region with a single axillary node enlargement noticed on examination by myself.  I determined via Pts history that she was not experiencing cardiac related chest pain as she was tender to palpation about the Lft axilla and pectoralis major of the Lft chest.  Pts Smallpox lesion was swollen and appeared consistent with other I have seen in the past.  The Pt did have significantly more discomfort at the lesion site and surrounding tissues than anyone I have spoken to including myself.  I did not order any diagnostic testing of any kind as this is a watchful waiting type of scenario and I felt the Pts symtoms would improve over time.
fatigue; dizziness; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (The patient received the Pfizer vaccine for her primary vaccination series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Nov-2021, the patient experienced FATIGUE (fatigue), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue), DIZZINESS (dizziness), CHILLS (chills) and HEADACHE (headache) had resolved.            No concomitant drug details were reported. No treatment details were reported.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/14/22 at approximately 08:50am. When error discovered facility contacted CDC for course of action. At direction of the CDC, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/31/2022. No adverse side effects or event as result of dose.
Description from ED: 16mo girl presenting for two seizure-like episodes today. She had generalized shaking with no focality noticed by the parents. The first episode lasted about three minutes and then she had another brief episode in the car on the way here. She was sleepy in between the episodes and did not return to baseline. Parents deny cyanosis or apnea. She continues to be sleepy at the time of the evaluation. Parents did notice some low-grade fever today following her immunizations (mom believes she received HepB and PREVNAR vaccines). However, she has not had cough, vomiting, diarrhea, or other symptoms of illness.
Information has been received from a registered nurse (RN) concerning a 19 week old female who on 11-APR-2008 and 05-Jun-2008 was vaccinated po with the first and second doses respectively of ROTATEQ. No adverse event was reported. It is unknown if medical attention was sought. A product quality complaint was not involved. No further information is available.
COVID infection with a normal chest x-ray and a normal oxygen saturation with no indication to treat the COVID at this time.
14 y/o received Varicella and HPV vaccines to left arm on 3-1-11. Pt presented on 3/3 and 3/4 with large area of swelling and erythema 15x16 cm pink changes 6x4 cm of induration & erythema.