chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Stomach discomfort; Swollen glands in the neck (front and back); Sore arm; Chills; Headaches; Stomach pain; Neck pain; Sore shoulder and collar bone; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), LYMPHADENOPATHY (Swollen glands in the neck (front and back)) and PAIN IN EXTREMITY (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History.  The patient's past medical history included No adverse event (No Historical condition reported). Concomitant products included EZETIMIBE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain), NECK PAIN (Neck pain), ARTHRALGIA (Sore shoulder and collar bone) and HEADACHE (Headaches). On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), LYMPHADENOPATHY (Swollen glands in the neck (front and back)), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Dizziness), ABDOMINAL DISCOMFORT (Stomach discomfort), LYMPHADENOPATHY (Swollen glands in the neck (front and back)), NECK PAIN (Neck pain), ARTHRALGIA (Sore shoulder and collar bone), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA of lots L015460 with expiry date 20-JUL-2017, M011116 with expiry date 17-JUN-2017, M018644 with expiry date 20-SEP-2017 (dose, strength, route, vaccination site unspecified). No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient with no known drug reactions or allergies. No information regarding the patient's medical history and concurrent conditions was provided. On 24-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # L013428, expiration date: 03-FEB-2017, intramuscularly in the left deltoid, (dose and dose number were not provided). There were no concomitant medications reported. On 25-AUG-2016, the patient returned to the pharmacy with an "area from the injection site in the left deltoid, down to the elbow" that was "red, warm to the touch and itchy". No laboratory diagnostics studies were performed. No treatment was given for the adverse events. The patient's status since 25-AUG-2016 was unknown. The relatedness between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 65 year-old female patient, who had no known allergy. On 11-Oct-2012 the patient received AFLURIA (batch number: P50008) injection at a dose of 0.5 mL intramuscularly. After receiving AFLURIA, the patient developed bruise around injection. The patient sought medical attention by speaking to the pharmacist. No treatment was given for the event. The event outcome was not reported.
Five days p/MMR vax was administered, pt experienced recurring headaches which continued until her death.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a 13 year old male patient. Medical history and drug reactions or allergies were not specified. On 13-MAY-2014, the patient was vaccinated with a first dose of GARDASIL intramuscular injection, in the left arm, dose and frequency reported as "as directed per the prescribing information", (lot number was not reported). Concomitant medications were not specified. On 13-MAY-2014, also reported as after receiving the initial dose of GARDASIL, the patient experienced light-headedness, severe pain in the injection (left) arm, working, severe headache and visual disturbances. The patient sought medical attention via office visit on 13-MAY-2014. The patient was treated with MOTRIN (unspecified dose and frequency). The outcome of visual disturbances, vomiting, severe headache, light-headedness and severe pain in the injection (left) arm was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
sore arm after a week, redness on upper arm where shot is located, big red circle, naseauted-1 week after shot
pt recvd vax & devel arthralgia & poss carpal tunnel synd 2 wks later; pt was placed on therapy w/Pred; No further details were provided;
Please tell your story.: On May 13, 2015, my husband recieved a Prevnar 13 vaccination shot. (Pfizer Prevnar 13 lot # L62072 / ex: 11/06/16 NDC # 0005-1971-02. My husband's symptoms started on 22 May 2015 with extreme pain in the pelvis and legs making sleep nearly impossible. On the morning of May 27th my husband thought he was having or had a stroke with the left side of his face drooping. We rushed to our 1st ER visit - May 27, 2015 where a diagnosis of Bells Palsy was made. Prednisone was prescribed for the Bells Palsy. On the following day we rushed back to the emergency room May 28, 2015, the paralysis had taken over the entire face - diagnosis Bells Palsy both sides. He told the doctors about pain yet they focused on facial issues and didn't seem concerned about the pain. The pain and sleeplessness continued. Then during the day of the 30th, the lower paralysis started setting in with unsteadiness progressing to staggering. By 3am the lower body paralysis was well established requiring a walker. We returned to the ER June 1st 4:30am! He was admitted that day and was given a spinal puncture with the diagnosis 1 hour later of Guillain Barre Syndrome, Miller Fisher Syndrome varient. Fortunately the GBS did not effect his respiratory or swallowing. My husband spent the next 8 days in the Neuro unit undergoing 6 plasma pheresis treatments and at all times was heaviliy medicated for extreme pain. On June 8, 2015 he progressed to the point where he was moved to the inhouse rehab center at the Hospital. At this point the focus was for PT, OT, and Speech therapy. He came home June 24, 2015 and is learning to walk and has a lot of recuperating with a full recovery in 6 months.
a lump in my lymph node on my right collarbone; cough; fatigue; At times I also have trouble focusing; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received dose 2 of BNT162B2 (lot number EP6955) via an unspecified route of administration on 24Mar2021 at 09:30 (at the age of 58-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included gout. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included allopurinol 300 mg from an unknown date for an unknown indication. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 (lot number EN6206) on 03Mar2021 at 09:30 as a single dose in the right arm for COVID-19 immunization. On 25Mar2021 at 07:00 the patient developed a lump in his lymph node on his right collarbone. It had reduced in size but was still present. He still had a cough and fatigue. At times he had trouble focusing. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. The patient received treatment with a steroid shot antibiotic shot, and cough medicine. The outcome of lump in his lymph node was recovering. The outcomes of cough, fatigue, and trouble focusing were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
developed rashes all over my back, arms legs, stomach area and all over my ankles.  Substances oozed out of the rashes It was itchy When They heal, they leave burnt scars
Arm became swollen and itchy. Injection site is red and hard slightly raised. Started one week after injection
Pt received COVID Pfizer vaccines on 04/08/21 and 04/29/21. Pt presented to the ED on 10/16/21 with complaints of difficulty breathing, and AMS. Pt was found to be COVID positive.
Loud tinnitus, ringing in both ears for 2+ months now. Worse in left ear.
Patient received 1st dose COVID vaccine (Moderna)  at another pharmacy, he then came to our pharmacy for his 2nd dose and we thought he was asking for Pfizer vaccine ( which we administered) Patient later brought his CDC card back to us and we discovered the incorrect second dose was given. He had no adverse reaction at the time.
Sleeping much more; weak; listless; muscle pain from his shoulders down to his toes on both sides; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping much more), ASTHENIA (weak), LISTLESS (listless), MYALGIA (muscle pain from his shoulders down to his toes on both sides) and FATIGUE (Tiredness) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024H21B, 021B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke. Concurrent medical conditions included Asthma, Diabetes, Neuropathic pain (That is isolated to his left side) and Heart disease, unspecified. Concomitant products included NORTRIPTYLINE and PREGABALIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (Sleeping much more), ASTHENIA (weak), LISTLESS (listless) and MYALGIA (muscle pain from his shoulders down to his toes on both sides). In December 2021, the patient experienced FATIGUE (Tiredness). At the time of the report, SOMNOLENCE (Sleeping much more), ASTHENIA (weak), LISTLESS (listless), MYALGIA (muscle pain from his shoulders down to his toes on both sides) and FATIGUE (Tiredness) outcome was unknown.            It was reported that the patient was able to eat a hearty breakfast of French toast. And in the call the HCP recommended hydrating with fluids like Gatorade. The reporter also states that the patient does not feel like when his blood sugar is low, with the tiredness.  Treatment information was not reported   This case was linked to MOD-2021-418130 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included multiple myeloma. On 6th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2018, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient stated that a week after receiving SHINGRIX, she experienced a mild case of shingles. The patient had not received the second shot of the SHINGRIX vaccine till the time of reporting. No further details were provided by the patient. Due to time constraint the patient disconnected the call.
Started with fever up to 103 all night long, irritability  and also vomiting bilious material  more than 10 times. Lethargy and difficult to feed
Red, raised, itchy, hard bump at injection site; Red, raised, itchy, hard bump at injection site; Red, raised, itchy, hard bump at injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included history of blood clot and osteoporosis. The patient had no known allergies. Concomitant medications included enoxaparin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), calcium, vitamin d nos (CALCIUM;VITAMIN D NOS) and prenatal vitamins; all were taken on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation and the patient previously received Tdap shot 5 years ago on an unknown date in 2016 and experienced red, raised, itchy and hard bump at injection site. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 17:00, 48 hours post vaccination, the patient had red, raised, itchy, hard bump at injection site and it kept growing bigger. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events red, raised, itchy, hard bump at injection site were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt age 12 received the Pfizer vaccine appropriate for ages 5-11. Pt remained in observation and left with guardian
A pharmacist reported that an employee received an injection of Flu Shield(1999-2000 Formula)on 10/6/99 and subsquently developed resp distress 4.5 hrs after immunization.  Pt. received oxy.,IV Benadryl, IV SoluMedrol, and SC epinephrine.
27 yo male with 3 days of fevers, chest pain x 3 days, beginning on 5/14/21 and presented to ED on 5/17/21. Found to have pericarditis and myocarditis, troponin I of 32.
abdominal surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 3-year-old female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number not reported), for covid-19 immunization. The following information was reported: ABDOMINAL OPERATION (medically significant), outcome "unknown", described as "abdominal surgery".  Clinical Course:The reporter had a three year old grand daughter who's going to be having surgery on Nov and they haven't scheduled the date and they really wanted to get her the vaccine for Covid-19 beforehand. Reporter said that her grand daughter already had two shots of the vaccine and would just like to know where they can be able to get the availability of the vaccine. Reporter said that they tried and is not getting yet and said that their granddaughter is having the abdominal surgery in Nov with no confirmed dates. Reporter wanted to get a hold of the vaccine in their county and wanted some help.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
UPPER BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, non smoker, and alcohol user, and other pre-existing medical conditions included patient had no known drug allergies or no drug abuse or illicit illicit allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) once a total dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced upper body aches. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, and had not recovered from fever, and upper body aches. This report was non-serious.
received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy ). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of vaccine in April prior to pregnancy and was due for her second dose in May but she did not get it) had resolved and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy ) outcome was unknown. 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.   No concomitant medications were not reported. No treatment medications were not provided.
FELT PARALYZED FROM THE NECK UP PHYSICALLY (NOT NEUROLOGICALLY); RESUMPTION OF FACIAL PAIN; RESUMPTION OF FACIAL SEIZURES; This spontaneous report received from a patient via a company representative concerned an adult male of unspecified race and ethnic origin. Initial information was processed with additional information received on 03-SEP-2021. The patient's height, and weight were not reported.  The patient's concurrent conditions included: trigeminal neuralgia, and environmental allergies, and other pre-existing medical conditions included: The patient had no other significant history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient was diagnosed with trigeminal neuralgia, facial pain and facial seizures 10 years ago, which has been well controlled by medication until 30-JUL-2021. The patient previously reported symptoms (facial pain) present only during very bad allergy seasons. On 30-JUL-2021, the patient experienced resumption of facial seizures and resumption of facial pain. On AUG-2021, the patient felt paralyzed from the neck up physically (not neurologically). The patient was assessed by their physician and it was determined that a blood vessel and nerve were touching, causing the facial pain and seizure/paralysis. According to the patient's physician, severe inflammation triggered by the vaccine was the cause for the return of the patient's symptoms (facial seizures and facial pain).The patient is receiving ongoing medical care to handle chronic pain symptoms. The patient may require surgical correction for relief. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from resumption of facial seizures, felt paralyzed from the neck up physically (not neurologically), and resumption of facial pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210905749-COVID-19 VACCINE AD26.COV2.S-Resumption Of Facial Seizures. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Pt. received PPV-23 on  8/29/16. On 8/30/16, pt. reported redness and swelling, was given KEFLEX. On 8/31 pt. presented to ER and was admitted. Pt. hospitalized until 9/3/16 for cellulitis.
Crying for 3 hours, right thigh is tender. Right facial swelling and angioedema with excellent response to 1ml of BENADRYL prior to visit. Persistent (3 1/2 hrs later) asymmetrical growth with crying (lower (R) lip not as noticeable).
Headache, NauseaVomiting, DAY 1-4 AFTER INJECTION: ARM PAIN, HEADACHE, ARM SWELLING 2-3 DAYS AFTER INJECTION, NAUSEA ON DAY 2 AFTER INJECTION, FATIGUE DAYS ONE AND 4 AFTER INJECTION Narrative: