chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix was administered to an 8-year-old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5A160084252) for prophylaxis.   On 27-SEP-2023, the patient received Boostrix. On 27-SEP-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix was administered to an 8-year-old patient).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter called to report Boostrix was administered to 8 year old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Starting from the first night after the vaccination and each and every night after that to date of this form completion, I have had extremely interrupted sleep.  I have woken up several times in the middle of the night (i.e., 2 am, 4 am, etc..). Each time I have woken up and felt wide awake and difficulty going back to sleep.  As a consequence each of the following days after this poor sleep I have been in extreme fatigue and not able to function properly.  I do not have any other notable side effects.  No fever or major headaches.  This disturbed sleep which coincidentally started right after the vaccination is highly concerning for me, especially since it has happened on 4 consecutive nights.  This has not happened to me before.  In the past even if I woke up in the middle of the night, I would fall back asleep relatively quickly.  Furthermore, it has not been the case of this type of lack of sleep for this many consecutive nights. Another observation is that my feeling of hunger seems to have increased for some reason.  Even in the middle of the night when I wake up I have felt great hunger and then starting in the morning that hunger continues.  This is more hunger than normal for me.  My diet and eating patterns have not changed compared to what it was before getting the first dose of the vaccination. Given that today is Martin Luther King Day and a Holiday my PCP is closed, so could not make an appointment or report this to her.  I will call my PCP again tomorrow, 01/19/21. If this disturbed sleep continues, then I am sure how I can properly function during a normal work day on the job. Given all the above I am also concerned about the second dose of the vaccination and what side effects that may result in.
Sore arm; Nagging headache; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program, . This 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she had her first dose of BNT162B2 on 12Mar2021 and had a sore arm and nagging headache. The patient inquired if she could take medications for her discomfort; if she could go to her mammogram appointment on Tuesday, 16Mar2021 and if not how long she would need to prolong her appointment; and if she could receive the echocardiogram she received with every doctor's visit and if not how long she should wait. The clinical outcomes of sore arm and nagging headache were unknown.  Follow-up attempts are completed. No further information is expected, information about lot number cannot be obtained.
Extreme fatigue / weakness; Foggy disposition; Intermittent chills; muscle aches; Diarrhea for roughly 3 weeks; This is a spontaneous report from a contactable consumer (patient herself) via COVAES. A 62-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL 1284), via an unspecified route of administration, administered in arm left on 05Jan2021 10:00 as dose 1, single for COVID-19 immunisation (at the age of 62-year-old). Medical history included penn.allergy and ongoing controlled hypertension. There were no concomitant medications. The patient did not took any other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 07Jun2021, the patient experienced extreme fatigue / weakness, foggy disposition, intermittent chills, muscle aches and diarrhea for roughly 3 weeks. Timeframe between vaccination and starting of symptoms was 1 day 14 Hours. The patient did not received any treatment for adverse events. On an unspecified date, the patient underwent lab tests and procedures which included stool test: negative and CBC test: negative. The outcome of the events was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Received shot in left arm. And now 5 months later the area hurts only when I move my arm in a certain way
Very mild pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Very mild pain at the injection site". No follow-up attempts are possible. No further information is expected.
Woke up on 9/6/07 - had pain top of shoulder to mid arm, burning sensation, hardness around injection site. SM c/o nausea and dizziness.
As soon as received FLUMIST got HA and 2 hours later started vomiting, fever 9-26-14.
Unmixed/undiluted pediatric vaccine (0.2ml) was given to the patient
6 month old female received a dose of Vaxelis and a dose of Pentacel; This non-serious spontaneous safety report was received by a partner on 08-MAR-2022 and forwarded to Agency on 09-MAR-2022 from a healthcare professional.  The causal relationship between Vaxelis and the reported event "6-month-old female received a dose of Vaxelis and a dose of Pentacel" is assessed as not applicable due to the nature of the event.  Further information is expected.
Information has been received from a registered nurse concerning a 10 year old male with no known allergies and a history of clubfoot at birth who on 05-JUN-1997 was vaccinated SC in the left thigh with a 0.5 mL first dose of Varivax (lot # 621071/1552D). There was no concomitant medication. On 22-JAN-2007, the patient presented to the office with chickenpox on the extremities and face and a scabbed lesion on the scalp. There were no frank vesicles. The child felt tired and ill five days prior (17-JAN-2007) and began the outbreak two days prior (20-JAN-2007). No treatment was required. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the nurse who reported that the patient was seen in the office by a physician on 22-JAN-2007 for three days of an itchy rash (started on 19-JAN-2007). He had five red bumps on his extremities and face, some scabs, one scabbed lesion on his scalp, and no frank vesicles. Isolation was advised. The patient recovered on an unspecified date. It was reported that the patient's sibling had a similar experience after therapy with Varivax (WAES # 0702USA00765).
Unable to sleep due to pain in right arm, chills, adjusted heat to try to sleep but that didn't work.  Decided to take hot shower but that caused me to vomit several times.  Once I stopped vomiting I started to feel better.
About 1 hr. after vaccination started low grade fever, chills, and headache, improved with TYLENOL. About 1.5 days after vaccination had headache, shoulder pain on right followed by swelling and painful swollen glands on clavicle (went to employee health and treated with ibuprofen). About 6 days after the shot I got swollen glands in my neck only on right side. As of 12 days since shot I still have swollen glands in my neck and clavicle, still some swelling over clavicle, and a headache that may or may not be related to the shot.
pt recv vax 1AUG95 & on 4FEB97 pt devel chickenpox;It was noted that pt entire body had lesions-including head, face, & ears;
I have like a nozzle on the inner part of my arm, closer to my arm like freezes; lymph node in same arm is swollen and my arm got worst; My arm where had vaccination was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 (Lot number: FA7484) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Aug2021, outcome "unknown", described as "My arm where had vaccination was sore"; FEELING COLD (non-serious) with onset 15Aug2021, outcome "unknown", described as "I have like a nozzle on the inner part of my arm, closer to my arm like freezes"; LYMPHADENOPATHY (non-serious) with onset 15Aug2021, outcome "unknown", described as "lymph node in same arm is swollen and my arm got worst". Therapeutic measures were taken as a result of pain in extremity, feeling cold, lymphadenopathy.  Additional information: Prior vaccination was reported as none. The patient took Ibupofen as treatment for the events.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered technician concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651330/1048P).  Subsequently the patient experienced red, hot sore arm at injection site within 48 hours post vaccination.  Treatment is unknown.  The registered technician had no other available information and placed a nurse practitioner stated that "she is not comfortable using this lot 1048P until a lot check is performed".  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 9/19/2022 PLEURAL EFFUSION  ACUTE RESPIRATORY FAILURE 9/19/2022 PLEURAL EFFUSION  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 9/19/2022 SYNCOPE  ACUTE RESPIRATORY FAILURE 9/19/2022 SYNCOPE  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 9/19/2022 ACUTE STROKE DUE TO EMBOLISM OF BILAT CEREBELLAR ARTERIES  ACUTE RESPIRATORY FAILURE 9/19/2022 ACUTE STROKE DUE TO EMBOLISM OF BILAT CEREBELLAR ARTERIES  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 9/19/2022 ADENOCARCINOMA, RIGHT LUNG UPPER LOBE  ACUTE RESPIRATORY FAILURE 9/19/2022 ADENOCARCINOMA, RIGHT LUNG UPPER LOBE  ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 9/19/2022 HEMOTHORAX  ACUTE RESPIRATORY FAILURE 9/19/2022 HEMOTHORAX
Cough Headaches,  Congestion or runny nose  Diarrhea sore throat
Moderna COVID-19 Vaccine EUA 10 minutes after receiving the shot, I got a headache and felt a lump in my throat.  Then I got a flushed face. BP was 200/100.  The health department wanted me to go to the ER but I declined because after two bottles of water and fanning myself BP went down to 180/90.  The nurse told me to take Benadryl and Tylonol as soon as I get home.  So I did every four hours.   Today (next day) I have brain fog, feel very weak and sore all over, have pain in my neck and head.  Also, the left side of my face and neck feel numb. I feel like when I first was diagnosed with Chronic Fatigue Syndrom and Fibromyalgia.  Very hard to do the simpliest of tasks
Patient received Harvix on 8/5/19 at  7:05 PM. They waited in Pharmacy for 15 minutes and went home.  Patient's husband called at 7:45 pm and stated she is experiencing Nausea and numbness on her lips. Pharmacist advised to take Benadryl and go to hospital immediately. We called her in morning at 10:25 am on 8/6/19 to check on her condition. Patient stated she  did not go to hospital but took Benadryl and feeling lot better. No numbness on lips anymore and Nausea getting better too. I also called MD t 10:30 Am 8/619 and had to leave message to follow up on Adverse reactions.
Hives. Red bumps that are itchy.  Recurring daily in the morning, occurring in various areas of body. Sometimes it skips a few days. Rash disappears after 3 hours, I guess. One instance happened after I applied a sunscreen before sun exposure- a hives reaction appeared where i applied the sunscreen product, arms, legs, head, neck, and shoulders.
Patient presented to ER on 2/16/2021 after getting covid vaccine 4 days prior. According to patient's family, she was moving slowly, not eating, experiencing some weakness and fatigue ever since. Patient was determined to have UTI and given 7 day course of cephalexin 500 mg three times daily. Followed-up with Health & Wellness on 2/17/2021. Patient went to ER again on 2/21/21 due to continued issues including altered mental status.
have welts around the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site wheal in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles couple of years ago).   In October 2020, the patient received Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was unknown.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix vaccine three days ago and had welts around the site that look exactly like the beginning of the shingles couple of years ago.  The reporter asked if those were still present and contagious.
Weakness; bad muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (bad muscle aches) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), MYALGIA (bad muscle aches) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weakness), MYALGIA (bad muscle aches) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported. No treatment drugs were reported. Consumer did not wish to be contacted any further.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620513 (Patient Link).
No additional AE.; PROQUAD that underwent a temperature excursion was administered at 1:00pm today; This spontaneous report was received from a registered nurse and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-APR-2022 at 13:00, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human Albumin (rHA)) subcutaneous injection, lot # U031564, expiration date: 06-APR-2023, administered for prophylaxis (strength, dose, anatomical location and route of administration were not provided). Prior to the vaccination, the vaccine underwent a temperature excursion of -9 degrees Celsius for 1 hour 45 minutes and 0 seconds (product storage error). There were no previous temperature excursions. No additional adverse event was reported (no adverse event).
Prolonged weight gain (40 pounds), loss of metabolism, loss of physical stamina, sexual dysfunction, fluid retention, high LDL cholestorol, joint stiffness, hypothyroidism, Diagnosed w/ Obesity and Hashimoto's Thyroiditis. Noticeable to patient beginning Spring 2014.
I immediately had joint pain and a runny nose. Woke up in the middle of night (early morning) with a fever of 101.6 and very specific joint pain and headache. I was sick like this for 5 days. My fever spiked at 103. Had chills and fatigue and slept non-stop.
patient called and reported having chills and chills causing uncontrollable jerking. Patient also reported extreme arm soreness but pain was controlled by OTC pain reliever.
Chills, dizzy, nausea, vomiting with belching, very sore left arm when I tried to raise it above head to reach for thermometer in overhead cabinet, temp 100.1 F at 8 p.m., 100.0F at 10 p.m. took ibuprofen around 10 p.m. slept nine hours and temp at 7:47 a.m. this morning 01/23/2021 97.7 F feel better no dizziness, can raise left arm without hurting, no vomiting but have a little queasiness.
Shingles - vesicular rash in L3-L4 dermatome on (R) acyclovir prescribed.
incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1688504 expiration date 19-NOV-2021 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.     Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
Historical Vaccine: Dose Number: 1, 2: Moderna, Dose Number: 3: Pfizer; Historical Vaccine: Dose Number: 1, 2: Moderna, Dose Number: 3: Pfizer; Tremendous pain in lymph gland in L armpit/side breast area. Same side as injection site.; Tremendous pain in lymph gland in L armpit/side breast area. Same side as injection site.; This is a spontaneous report from a contactable other hcp. A 57-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590), via an unspecified route of administration in the left arm on 04Nov2021 at 12:00 (at the age of 57-years-old) as DOSE 3 (BOOSTER), single dose for COVID-19 immunisation. Medical history included allergies to Compazine (prochlorperazine maleate) and amoxicillin. Concomitant medications included medroxyprogesterone, montelukast, cetirizine hydrochloride (ZYRTEC) and calcium taken for an unspecified indication, start and stop date were not reported. Patient received two historical doses of Moderna vaccines (Dose 1 on 06Jan2021, lot no.025J20-2A and dose 2 on 03Feb2021, lot no.043L20A) prior to the vaccine. On 05Nov2021 at 02:00 the patient experienced Axillary pain, Lymph node pain. On an unspecified date the patient experienced off label use and interchange of vaccine products. The outcome of the events Axillary pain, Lymph node pain was not recovered. The outcome of the events off label use and interchange of vaccine products was unknown.
Injection site reaction; First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt; First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt; First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt; First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt; First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE WARMTH (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE PRURITUS (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE SWELLING (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt) and VACCINATION SITE ERYTHEMA (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TELMISARTAN, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE and PREDNISONE for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE WARMTH (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE PRURITUS (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE SWELLING (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE ERYTHEMA (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt) and VACCINATION SITE PAIN (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt.). At the time of the report, INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE WARMTH (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE PRURITUS (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE SWELLING (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt), VACCINATION SITE ERYTHEMA (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt) and VACCINATION SITE PAIN (First it was itching, then 6 inches in diameter was hot, swollen and red. Also hurt.) outcome was unknown.            The concomitant medication included benadryl.