chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner via Poison and Drug Center concerning a 62 year old female patient with chronic lymphocytic leukaemia, hypercholesterolaemia and brain meningioma. Concomitant therapies included LIPITOR, ZETIA, aspirin, ANUCORT and calcium (unspecified) (+) vitamin d (unspecified). On an unknown date, relevant lab work included white blood cell count (WBC): 23.6 (units not reported) (elevated), absolute basophils elevated, "MPB" 12.0 (units not reported), absolute lymphocytes 17,228. On 10-DEC-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # reported as 7002681500, expiration date: 05-NOV-2016) one prefilled syringe, once, intramuscularly for prevention. The patient was nervous about receiving expired vaccine but was not experiencing any other effects from receiving the expired vaccine. As of 10-DEC-2016, it was unknown if the patient would continue on the PNEUMOVAX 23 and the outcome of receiving an expired PNEUMOVAX 23 was unknown however the patient continued to experience nervousness regarding receiving the expired vaccine. The relatedness between nervousness and PNEUMOVAX 23 was not reported. Additional information has been requested.
Is pregnant: Yes/delivery date: 30Dec2022; Nausea; Vomited; Diarrhea; Headache; Muscle ache; Tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 23Jun2022 at 16:30 as dose 3 (booster), single (Lot number: FP4554) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Date of last menstrual period: 27Mar2022. The patient was 13 weeks pregnant at the time of exposure to BNT162b2. The patient was 12 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 30Dec2022. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose 2, Location of injection: Arm Left, Vaccine Administration Time: 13:00), administration date: 27Jul2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Location of injection: Arm Left, Vaccine Administration Time: 13:00), administration date: 09Jun2021, when the patient was 41-year-old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Diarrhea"; HEADACHE (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022); MYALGIA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Muscle ache"; NAUSEA (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022); FATIGUE (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Tired"; VOMITING (non-serious) with onset 24Jun2022 at 16:00, outcome "recovered" (Jun2022), described as "Vomited"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes/delivery date: 30Dec2022". Therapeutic measures were not taken as a result of nausea, vomiting, diarrhoea, headache, myalgia, fatigue. Additional information: 24 hours after the vaccine, she started getting strong nausea, she vomited and had diarrhea. Also headache, muscle ache and very tired. No known allergies reported. No other vaccine in four weeks. List of any other medications the patient received within 2 weeks of vaccination: Amoxicillin, Prenatal vitamins. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Device date: 25Jun2022.   No follow-up attempts are possible. No further information is expected.
Heart palpations, dizziness, headache, nausea, SOB - hurt to breathe, fever 3/30/09-records received-office visit 10/26/07-follow up of asthma since prior visit 1 year ago. No asthma flares has had significant exercise induced bronchospasm sysmptoms, exercise pretreatment is inconsistent. Office visit 2/12/08-C/O headche comes and goes, some blurring of vision mostly right eye, light sensitivity and sound sensitivity with nausea. Cheecks feel hot with headache. Currently menstrating. Family history of migraine. ER visit for headace pain. Now with neck pain on right side with right arm felt weak.New glasses Rx makes vision blurry and not helping her eye sight. Old rib injury in December. Assessment: headache, cervical subluxation. 4/11/08-follow-up for asthma, episode of shortness of breath. Intermittent abdominal pain into right lower quadrant especially when nauseated. Similar to reflux symptoms. 4/23/08-3 week history of abdominal pain, nausea vomiting and bloody emesis. Pain in epigastric region and right upper quadrant mid area. Assessment:epigastric pain secondary to gastritis or gastric ulcer disease. 1/10/09-evaluation for headaches, dizziness and syncopal episodes. Behavior started in 9/08 with dizziness and passing out episodes. Second episode in December with dizziness and collapsed and unresponsive and confused. C/O pain behind right eye, numbness and inability to move left leg for 30 minutes. Assessment: migraine headache. Vertigo. Functional component in patient's behavior.1/17/09- C/O dizziness and nausea and not feeling well. 2/20/09 presented to ED with altered LOC, can not remember events of day. Diagnosis:migraine variant. Office visit 2/23/09-follow up for C/O right upper quadrant abdominal pain with multiple vague complaints. Assessment:psychological and panic attacks.
This case was reported by a physician via call center representative and described the occurrence of shingles in a elderly patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The reporter said that the patient had to receive the second dose of SHINGRIX in August 2018, but the patient came down with clinical shingles and treated with Valtrex. It has resolved. The reporter asked that if the patient could receive the second shot and if so when. The reporter received answer that it was not a contraindication to give the 2nd dose of SHINGRIX if there was an episode of Herpes zoster after the first dose of SHINGRIX. The center of disease control and prevention recommendation for vaccinating after an episode only stateed the lesions need to be resolved. There was no additional period of time that needed to pass. In September 2018, the reporter would probably give the second dose of SHINGRIX to the patient.
Pt has normal swelling on the right arm. Pt also has pain (severe) radiating throughout the whole right arm for 3-5 days. The pain subsided and patient is well after 1 week.
headache 24 hours after with low grade temp of 101.6, pain at injections site.
General weakness and mild body aches for two days, minimal injection site soreness for three days, mild sneezing/runny nose for two weeks.
@ 24 hr red, tender, swollen, hot 4x6 cm area to injection site  @ 48 hr bright red, tender, indurated, very swollen, hot 6x8 cm area to injection site - ice to site 4-5x/day @ 72 hr red, tender, very swollen, hot and indurated 5x8 area to injection site
Information has been received from a physician concerning a 65 year old female who was vaccinated with a 0.65 ml dose of Zostavax. It was reported that "1-2 days after vaccination", the patient experienced fever, nausea, rash and swelling around injection site. At the time of report, the patient was recovered. A product quality complaint was not involved. Additional information has been requested.
Patient was sick with flu like symptoms, fever and congestion, until April 5, 2021. He had a massive heart attack on 04/06/2021 died instanly.
This spontaneous report was received from a 21 year old female patient reporting on herself. Patient did not have any pertinent medical history, drug reactions and allergies. The patient was not pregnant. The patient stated that she had received all three GARDASIL vaccines starting in 2008 first dose (dose and Lot number not reported, route reporting as injection). (Second injection and third doses were administered on an unspecified dates). No concomitant medication was reported. In approximately March 2014 (reported as "last week") the patient was tested positive for HPV. The patient sought medical attention by visiting her doctor. No treatment was given. The physician was performing a biopsy for a patient (in an approximately March 2014, result not provided). The outcome of positive HPV test was reported as not recovered. Action taken was not reported. Relatedness between event and GARDASIL was not reported. Additional information has been requested.
Lrg reaction extending below elbow with pain. Also with nausea. Prednisone x 5 days.
Initial unsolicited report received from a Consumer on 24 February 2016. This case involves a 50-year-old female patient who was vaccinated with an intramuscular dose of Fluzone (batch number, expiration date, dose, doe in series were not reported) in left deltoid 01 November 2015. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was bunion left foot. Concomitant medications were not reported. On 17 November 2015, 16 days, (reported as two weeks to a month) following the vaccination, the patient experienced pain in the left foot near her bunion, in the joint area her toe. It hurt to wear shoes and the area hurt if you pressed down on it. No redness or swelling noted. It was reported that pain was intermittent sometimes she forgot she had it. Patient was also experiencing the same burning pain in her left hand, middle finger, joint pain. Patient also had soreness and bruising at the injection site for one week. Lab data and corrective treatment was not reported. The patient was recovered from soreness and bruising at injection site. Patient was not recovered from other events. List of documents held by sender: none.
PATIENT COMPLIANED OF MUSCLE AND JOINT ACHES, NAUSEA AND FEVER.
Pt. states that after receiving the 1st dose of Phizer 10/06/2021, started experiencing symptoms 10/09/2021 of full body spasms, Blood Sugar +300, chest pain, and passing out spells. Biting of the tongue during spell (similar to Seizure) Emergency Room visit 10/09/2021 CT Scan, Blood Work, EKG, and Ultrasound. Diagnosed with Vertigo and follow-up with Neurologist. Appt. with Neurologist 01/2021, still experiencing symptoms with High Blood Sugar readings continuing.
Waited 30 minutes in clinic.  As she was exiting, she felt chest tightness and SOB.  Rapid response called.  Pt was evaluated by RR and dc'd back to clinic.  Chest tightness improved.  Refused ED.
At 3 a.m. on the 21st, approximately 18 hours after vaccine, got up to go to the bathroom.  Felt weak and passed out on bathroom floor.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown.  The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.  This case contains information for patient 5 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Immunization: COVID-19 mRNA, LNP-S, (Pfizer-BioNTech) - Pfizer vaccine was administered outside of the clinic - reported by patient
pt recv vax; apparently turned blue, became limp & unresponsive for about 30 sec;
Patient was scheduled to receive his second monovalent vaccine.  The patient was given a Bivalent vaccine instead.  No adverse reactions noted by the parents.  Pfizer was notified and provided the information that no further Bivalent vaccine should be given at this time.  Reached out to our medication safety officer who suggested that the patient come in for his second monovalent 2-3 months.  Parents were notified and the patient is scheduled to receive his second monovalent in Jan 2023.
pt recv vax; approx 2 hr later,c/o swollen, itchy at rt eye; noted rash on chest;red welts;MD called; meds given;
By 7:45 that evening, I was TIRED. I went to bed shortly thereafter and slept for 11 hours. The following day (2/25) I was equally tired, had some cold chills, and some body aches at the end of the night. That evening, I slept for another 10 hours. Over that weekend, I was still not feeling 100%. By Monday I would say I had returned to normal.
1st shot: hives across the body lasted for over a week and began the day after the dose was received 2nd shot: dizziness 10 minutes after the injection followed by headache, fatigue, chills, and muscle aches across the body  Treatment: contacted doctor to confirm appropriate treatment of hives
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose  01/06/21 pfizer,Lot#EL3248 2nd dose 01/27/21 Pfizer,lot#EL9262 Diagnosed covid positive:08/04/21 Symptom onset:08/02/21 Exposure:unknown Symptoms:Fever, cough, sore throat, chills,headache ,stuffy  nose
Severe pain in left shoulder and rotator cuff 3 hours after shot received.  Could not move arm an inch from my body without severe pain.  Alternated heat and cold compress and took advil, tylenol and alleve but nothing seemed to help.  Minimal decrease in pain and minimal increase in movement after approximately 16 hours.  Good improvement in pain and movement after  24 hours.   Mobility in arm back to 95% after 48 hours.  4 days later have completely recovered except for some  pain when pulling a shirt over my head.
Myalgia, 30 mins p inj hot face, tingling lips x 15 mins. Headache, body aches and joint pain with fatigue Narrative: Told to take benadryl before next Moderna dose in February
got shot and had shingles/suspected vaccination failure; shingles; pain from the shot; chills; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and chills. On an unknown date, the outcome of the vaccination failure, shingles, pain and chills were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had pain from the shot and also experienced chills. The patient also had shingles and it was a million times worse than the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient sates an extremely large, red, hard area going down the arm to the elbow. And a lump under the left armpit. She stated the injection was given low on her deltoid. Felt it wasn't given in the heart of the muscle. Wondered if that had something to do with it.
She got Depo-Provera first shot on the same day, on 7-11-2012 and was fine until over 48 hours later. She had onset of diarrhea with abdominal pain. Low grade/subjective fevers and nausea.  Dizziness and increased "frustration".  Subjective swelling of her face- puffy eyes and lower abdomen.
Dizziness, Brain Fog, Immediate Menstruation (25 min post shot).
Low grade fever (99); very tired; Chills; muscle pain; Joint pain; headache; Sore arm; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Apr2021 at 16:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) and nigella sativa seed oil (black cumin seed oil) (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. The patient previously took Aspirin and experienced allergy to it. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Mar2021 at 16:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 11Apr2021, within a few minutes, the patient experienced injection site pain. On 12Apr2021 at 09:00, the patient experienced low grade fever (99) after 18 hours, tired, chills, muscle pain by 24 hours, joint pain, headache by 27 hours, very tired, and sore arm. Therapeutic measures were not taken for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent. On 12Apr2021, the patient underwent body temperature and the result was 99 (unspecified units). The clinical outcome of the event injection site pain, low grade fever (99), chills, muscle pain was resolved in Apr2021, joint pain and headache was resolved on 13Apr2021, very tired was resolved on 14Apr2021 and sore arm was resolved on 15Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
bad allergic reaction to Prevnar13; The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 27Jan2020, this case now contains all required information to be considered valid.  This is a follow-up spontaneous report from Pfizer-sponsored programs, received from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphteria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient did not engage to a doctor, health care professional or pharmacist to get vaccinated in the past 3 months as she had a bad allergic reaction to pneumococcal 13-valent conjugate vaccine (diphteria crm197 protein). Outcome of the event was unknown.  Information on the lot/batch number has been requested.
whole body was weak; heavy mucus cough; hideous dry mouth; body felt like it had no bones; really really terrible; fell asleep in a stupor for 24 hours; felt like she was a snake; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (whole body was weak), COUGH (heavy mucus cough), DRY MOUTH (hideous dry mouth), FEELING ABNORMAL (body felt like it had no bones) and FEELING ABNORMAL (really really terrible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 ASTHENIA (whole body was weak), COUGH (heavy mucus cough), DRY MOUTH (hideous dry mouth), FEELING ABNORMAL (body felt like it had no bones), FEELING ABNORMAL (really really terrible), INSOMNIA (fell asleep in a stupor for 24 hours) and FEELING ABNORMAL (felt like she was a snake). At the time of the report, ASTHENIA (whole body was weak), COUGH (heavy mucus cough), DRY MOUTH (hideous dry mouth), FEELING ABNORMAL (body felt like it had no bones), FEELING ABNORMAL (really really terrible), INSOMNIA (fell asleep in a stupor for 24 hours) and FEELING ABNORMAL (felt like she was a snake) outcome was unknown. Not Provided          No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Severe muscle aches in upper left back and left chest starting one hour after getting seasonal flu shot.
First febrile seizure (simple) occurred 02/13/2003-10 days following MMR vaccine.
Information has been received from a registered nurse concerning a 5 year old female child with no medical history or allergies who on 30-APR-2007 at 4:00 PM was vaccinated SC on left arm with a dose of ProQuad (Lot# 656313/0298U). At the time of vaccination the patient did not have any illness. One day after vaccination, on 01-MAY-2007 the patient developed red, painful, swollen arm that was warm to touch. No medical attention was sought and no diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from the registered nurse who reconfirmed that the patient experienced a red, painful, swollen arm that was warm to the touch in the AM of 01-MAY-2007. It was reported that the patient recovered on 03-MAY-2007. No further information is expected. This is one of several reports received from same source.
Info has been received from a physician concerning a 6 year old male, who was exposed to his grandfather with shingles, who was vaccinated with a dose of varicella virus vaccine live. "Last week", on approximately, 1/25/06, the pt developed a mild case. No hospitalization or treatment was reported. The pt's brother had a similar reaction following vaccination with varicella virus vaccine live. Additional info has been requested.