chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-OCT-2015 00:30, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 4.9 and 4.7 (16hours 2mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
like having flu; like having allergy; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like having flu), HYPERSENSITIVITY (like having allergy) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like having flu) and HYPERSENSITIVITY (like having allergy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (like having flu), HYPERSENSITIVITY (like having allergy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that two weeks ago, patient started to have headaches and are not constants but sometimes she gets them (one day on, one day off). No concomitant medication was provided.
discovered during processing hours after administration that patient was to have received the adult/purple lid pfizer and actually received pediatric/orange lid pfizer.  no actual adverse events occured
Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender 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, the patient experienced WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.) 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 WRONG PRODUCT ADMINISTERED (Wrong formulation to patient. Patient 6mo-5yo: they should have administered 2 doses of 0.25ml from the Dark Blue Cap and Label with Gray Border but instead they administered 2 doses of 0.2ml from the Dark Pink Cap and Label with Yellow Box.).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731451 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731451:Same reporter (Patient 1)
Patient started having an itchy arm immediately after the injection.  In 15-20 minutes he had an itchy throat and some swelling. 911 was called.  Medics responded and assessed patient. Patient went to the ER and was treated with Benadry and prednisone and sent home.
Patient received the vaccine as a result of a medication error; he was only 17 at the time of administration, and should have been 18 to receive Moderna.  Spoke with the patient on 2/8/21 and he reported no adverse reactions (local or systemic) to vaccination.
Mother reports child developed rash on chest and abdomen w/in 24 hrs of receiving DTaP and Varicella. No fever or urticaria. Rash fully resolved w/out incident.
Patient stated she had a headache, fever, chills, swollen arm the day of the vaccine.  The next day she felt very sick went to the Dr and the Dr stated she had an infection and prescribed an antibiotic.
Patient received DTaP, IPV, HIB and Prevnar (second doses) 3/25/05. 22 hours later he had seizures and fever and was admitted to pediatric ICU where he is still hospitalized. Follow up report received from 05/16/2005:  Pneumonia Per follow up report received on 06/14/2005:  Patient had 4 more seizures, and is now on Phenobarbital. Per follow up report- He continues to be followed by neurologist for myoclonic seizures and Right or Left local seizures.
Extreme brain fog and exhaustion for 4 days followed by immediate onset of head cold for 3 weeks
Pt received vaccine at 10:47AM. At around 10:55AM pt complained of dizziness and feeling sweaty, and like her "blood sugar was low." Reported her diabetes medications were adjusted the day before. On exam pt was diaphoretic and tremulous. Blood glucose was 35 mg/dL. BP was 223/118 and repeat was 220/118 mmHg.  HR was 85bpm and Sp02 was 95%. Pt denied chest pain or shortness of breath. Given 4oz juice and 15min later blood glucose was 72 mg/dL. EMS was called for possible hypertensive crisis and further management of hypoglycemia. Pt was in no acute distress at time of transfer.
11/13/2002- day following flu shot, client reported that she developed a 2in circular red area at injection site- warm to touch, no pain. On allergy shots and weaning off at time of injection. Took Benadryl BID and used Cortisone Cream on area. 11/14/2002 c/o generalized aching, low grade temp, and flu like symptoms and took Tylenol. 11/15/2002 Feels better and redness in arm subsided. 11/20/2002 completely recovered.
Patient was sitting in observation and after 5 mins patient began c/o itching of neck. Upon exam patient exhibited urtacaria of neck and chest. Patient denied any difficulty breathing or shortness of breath. LS:CTAx4, VS: 132/68, RR:16, HR:92, SPO2: 99% on room air. Patient was given Benadryl 50mg IM in Left Deltoid. Patient was reassesed at 5 mins post benadryl administration with relief of itching and urtacaria still present. Patient still denied difficulty breathing. @ 10 mins patient had complete relief of symptoms. Patient stayed additional 10 mins w/o incident. Patient instructed to follow up with physician or call 9-1-1 in case of emergency. This is the correct report has wrong date of 4/3/21; i
Patient stated in report was given his second COVID Moderna dose too early, on day 20. Pt had an appointment scheduled for day 30 but presented early and it was not caught by registration or by the medical provider until after the 2nd dose had been given. The patient was informed of this vaccine administration error, and advised per current CDC recommendations he should not receive any more vaccines. The patient was monitored for the recommended 15 minutes after receiving the vaccine, and did not report having any side effects. He was advised to contact the medical provider on site if any problems arose in the future. Information from both vaccine doses is recorded in the company's EMR.  This provider contacted our head of Health Center, and was advised to determine how the error occurred and implement strategies to prevent it from happening again. This provider reviewed how the error occurred with the team. The mobile health director filed an internal incident report. This provider was also advised to file a VAERS report.
Clinic nurse administered COVID-19 vaccination on 4/15/2022; vaccine beyond use date 4/12/2022.
cold-like symptoms started on 06Apr2021 and have worsened; cold-like symptoms started on 06Apr2021 and have worsened; This is a spontaneous report from a contactable female consumer(patient) via Medical Information Team and report from Pfizer sponsored program. A female patient of an unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on unknown date as single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. On 06Apr2021, the patient had cold-like symptoms and have worsened. The patient would like to add that during the pandemic, and she have practiced the suggested safety protocols and only go out in public when necessary. Outcome of the events cold-like symptoms  and have worsened was unknown.  Information about lot/batch number cannot be obtained. No follow-up attempts are needed.
brain fog/like a haze cannot think at a high level; headaches; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient). A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 07Apr2021, as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had COVID-19 in January 202. In Apr2021, the patient experienced brain fog which started a few days after receiving the vaccine. He experienced like a haze cannot think at a high level and it lasted for a while. Patient also had headaches and extreme exhaustion. He enquired whether this was normal and asked whether to receive the second vaccine dose or not. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm pain at injection site has lasted for over a month  Periods have changed - heavier, more painful, longer
Generalized arthralgia; relieved w/motrin except for residual stiffness, soreness in finger and wrist joint of left hand. Report on 9/27/19 is that arthralgia is gone and selling of left axilla node is better.
Vaccines received on 7/6 afternoon, when picked up from daycare on 7/7 pt was noted to have hives on bilateral thighs as well as right forearm, cheek and right shin that started around lunchtime.  Pt was given cool bath and dose of 12.5mg diphenhydramine.  Improvement of rash noted throughout evening.  During the following week pt would have episodes of transient urticaria in various locations several times a day without identifiable triggers.  Of note for week leading up to and following vaccination pt had afebrile viral cold with significant URI drainage and mild cough.
03/28/2021-3 days after the vaccine,  my right arm began to hurt,  was stiff and was swollen,. The pain was so  severe that  I could not move my right arm arm. The lymph nodes on my right side of my neck were swollen. I called the Health Clinic and they prescribed me Gabapentin. I stopped taking the Gabapentin because I did not feel they were helping me and they would make me sleepy.  I was taking acetaminophen.   I do not know if this is an adverse event to the vaccine because  my left arm was was bothering me one week prior to the vaccine dose 1  and the doctor diagnosed my left  arm as frozen arm.  The swollen arm, stiffness and swollen lymph nodes resolved after 2 weeks in my right arm.
Patient experienced dizziness, elevated blood pressure and increased heart rate.  Diphenhydramine 50mg IM was administered into right deltoid.
Left arm swelling and pain as well as pruritus. Rash present overlying injection site.
PATIENT RECIEVED VACCINE DOES ON 3/15/21 & 4/12/21. CONTRACTED COVID AND WAS HOSPITALIZED FOR 19 DAYS. PATIENT WAS ATMITTED ON 8/21/21 AND DIAGNOSED WITH COVID PNEUMONIA + HYPOXIA + LEUKOCYTOSIS. PRESENTS WITH SOB, WEAKNESS, FATIGUE, DECREASED ACTIVITY, LOSS OF APPETITE, MUSCLE PAIN, PATIENT WAS EVENTUALLY TRANSFERED TO A EXTENDED CARE FACILITY.
Through an error in communication, I administered a flublok vaccine to a patient when he was expecting a pfizer vaccine. After receiving flublok, patient stated that he was allergic to eggs and couldn't get flu vaccine. After apologizing, I explained that flublok was an egg free vaccine. I then administered Pfizer vaccine and counseled patient on possible adverse effects from receiving both Pfizer and flublok. To my knowledge, patient never reported any adverse events to this pharmacy. He may have reported elsewhere. I reviewed vaccination protocol with my pharmacy manager and technician who was involved in the error.
After 2 mo (vaccines x7) Pt developed sleeping problems, discussed at 4mo appt. At which time pt got (shots x 7) at 6 months check up pt had dry eczema on trunk and faint rash and swollen lymph node under right arm. Develops into N/R sarcoma of peripheral nerve sheath. Pt had 2 month shots, 4 month shorts, 6 months he wasn't well, no others given. Death Certificate received which revealed COD as metastatic epitheloid sarcoma.
This spontaneous report as received from a Registered Nurse refers to a 4 year old male patient of unknown gender. On 15-JUL-2014, a 0.5 ml of (Oka/Merck) VARIVAX (lot # unspecified) subcutaneous, (frequency and location unspecified) which was underwent a temperature excursion was administered to the patient. No adverse effect reported. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Pt developed morbilliform macular papular rash onset 24 hrs after Influenza vaccine. Treated with Benadryl.
Pt recvd vax & exp pain @ inject site; also exp pain in arm that recvd inject & had difficulty w/abduction & rotation of shoulder; pt treated w/analgesics; pt was unable to sleep;
Fever 103, malaise, pain, cellulitis to area; hospitalization.  Nurse follow up on 09/01/04 states: "Allergic reaction to Pneumovax."
Headache,  malaise, fatigue, dizziness, weakness,  chills and hot flashes
I have a sleep problem almost eight hours; I was so tired; Headache; My arm was sore for 24 hours; so stiff; This is a spontaneous report from a contactable physician. A 69-year-old patient of an unspecified gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVD-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the vaccine and had a pretty significant reaction, one say serious to moderate reaction. The patient's question was do they know yet if you take a second shot was your reaction get even worse because the patient had a sleep problem almost eight hours. The patient was so tired, had headache and so stiff, arm was sore for 24 hours. The patient was a little afraid to take a second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 agencys, Ethics Committees, and Investigators, as appropriate.
Client fully vaccinated for COVID-19 developed breakthrough infection and tested positive via PCR on 7/2/21. Vaccine dose #1 administered on 2/5/2021 and dose #2 administered on 3/5/2021. Client was hospitalized on 7/2 for COVID-19 pneumonia and subsequently died on 7/24/2021.
Headache; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (soreness in the arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (soreness in the arm). On 06-Mar-2021, VACCINATION SITE PAIN (soreness in the arm) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .   This case was linked to US-MODERNATX, INC.-MOD-2021-067311 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067311:Original Case : MOD-2021-067311
Arm swelling and terribly sore. Cannot hardly move it. Still swollen, Hard to the touch after 60 hours later. Also have fever of 101.3  Will contact Doctor's office tomorrow. But not sure I will be able to go to work and do my normal job.  Manufacturing. Running a machine. Back and neck are also sore but not unbearable.
Site: Pain at Injection Site-Mild, Additional Details: On the first attempt at giving the vaccine the patient began getting upset and said she had not had time to think about it and prepare enough. I gave the next patient their vaccine while she took a minute to calm down. I tried again and she still pulled away when I tried to give the vaccine. I left the room and came back. On the 3rd time I was able to get the vaccine, but mom said daughter did not give consent and I should never treat a special needs child like that again.
child started running 104-105 fever around 12:00 am on 06/03/19. Child was still running fever and started having a spotty rash on 06/06/19. Mom stated he was not wanting to eat or drink. Mom took him to see Dr. 06/06/19. Dr thought child was having an adverse reaction to the vaccines but was not concerned about fever. He stated fever was normal after receiving vaccines. No treatment. Fever stopped 06/07/19. Mom took child to ER on 06/08/19 with rash. ER doctor said child may be having allergic reactio to vaccines. Child also had irritated throat and was treated for strep rash with Amoxicillin. Mom alternated Tylenol and ibuprofen. Rash gone by 06/09/18
Adverse reaction: lightheadedness and sweating. Place pt in supine position, Monitored VS continuously. BP stabilized prior to discharged @ 1PM BP 106/74 HR 68
This spontaneous report was received from a health professional (medical assistant) and refers to an unspecified number of patient of unknown age and sex. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA. No adverse effects were reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
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 25-JUL-2016, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10 (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had nine temperature excursion: 88 hours, 1456 hours, 64 hours, 232 hours, 328 hours, 72 hours, 64 hours, 40 hours and 488 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 478F (8.888888889 Celsius). 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.
11/3 pt recv vax at approx 1:15 pm. At approx 4:00 pm noted rash around mouth. Progressed to hands and legs/feet by later that evening. Mom call 11/5 to notify. 11/6 pt evaluated and treated with Prelone. Rash resolved over next 2-3 days.
Initial solicited case received from the investigator in a trial on 02 September 2015. Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This case involves a 24-year-old male subject who developed non-specific myocarditis during the study participation. The subject had medical history of elevated cholesterol and headaches. The subject received a first dose of anthrax vaccine concomitantly on 01 July 2015. On 12 July 2015, 11 days after receiving a dose of ACAM2000 on 01 July 2015 (batch number, route and site of administration not reported), the subject had non-specific myocarditis. The subject's blood test done on 12 July 2015 recorded the highest value of troponin I as 2.82 which was abnormal. The subject's ECG done on 12 July 2015 was normal. The subject's echocardiogram, MRI (brain, spinal cord and heart) and lumbar puncture was not performed. The subject's corrective treatment was not reported. Outcome of the event non-specific myocarditis was not reported. Relationship to investigational product according to company: associated. Whether the serious adverse event led to the termination of the subject from the study or not was not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Within minutes of injection patient developed redness at injection site.  Redness and itching progressed down left arm and into left hand  in patches. Administered 50 mg diphenhydramine 10 minutes after vaccine administration.
Patient is a 46-year-old female, yesterday she had a DPT and a PNEUMOVAX.  In the arm in which she had the DPT the right shoulder, there is erythema, warmth, a large knot.  Patient developed fevers.  Tonight she came into the emergency room and her temperature was 101.5, earlier she says that it was 103.  She also was severely hypertensive with a blood pressure of 191/100, pulse 152, respiratory rate 24, all consistent with sepsis.  Patient's blood work reinforced this with a lactic acid level of 3.47, white count of 18,8 with 88% neutrophils.  She also had an elevated sugar on the Chem-12 of 148.  Urinalysis was negative.  Lactic acid, I think was mentioned above, 3.47.
Pneumococcal conjugate was administered on left deltoid on11/22/04. Today 11/24/04 AM, mother noticed daughter's arm was slightly swollen and bad erythema. 65mm in width x 68mm in length. Call of mother states it was warm to touch, denies pain or itchiness. T96.7, P108, R26 BP85/50
No symptoms 15 minute after receiving injections. Mild symptoms four hours later. Strong but tolerable symptoms that required me to lay in bed and stay there eight hours after vaccination. Symptoms started with chills and progressed to body aches, headache, fever, and some tingling in my arms. Arm is sore at the injection site.