chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WORSENING SINUS SYMPTOMS WITH RUNNY NOSE/ SEVERE HEADACHE AROUND SINUSES AND TEMPLES; ITCHY ARMS; COUGHING UP YELLOW; GREENISH-YELLOW COLOR BRUISE AT THE INJECTION SITE; WHOOSHING IN EARS; PAIN IN LEFT HAND ACROSS JOINTS OVER THE KNUCKLES; NAUSEA; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus symptoms. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820096, expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced worsening sinus symptoms with runny nose/ severe headache around sinuses and temples. On AUG-2021, the patient experienced itchy arms. On AUG-2021, the patient experienced coughing up yellow. On AUG-2021, the patient experienced greenish-yellow color bruise at the injection site. On AUG-2021, the patient experienced whooshing in ears. On AUG-2021, the patient experienced pain in left hand across joints over the knuckles. On AUG-2021, the patient experienced nausea. Treatment medications (dates unspecified) included: ibuprofen, sucralfate, acetylsalicylic acid/caffeine/paracetamol/salicylamide, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from itchy arms on AUG-2021, was recovering from nausea, and the outcome of coughing up yellow, pain in left hand across joints over the knuckles, worsening sinus symptoms with runny nose/ severe headache around sinuses and temples, whooshing in ears and greenish-yellow color bruise at the injection site was not reported. This report was non-serious. This case, from the same reporter is linked to 20210832299.
This spontaneous report as received from a physician refers to a 19 month old male patient (at the time of the event) diagnosed with spherocytosis. On 26-JUL-2013 the patient was vaccinated with VARIVAX (Merck) (lot and expiration date were not provided). Co-suspect or concomitant therapies were not reported. On 30-NOV-2013, 128 days after onset of therapy the patient was diagnosed with shingles after receiving VARIVAX (Merck). The outcome of shingles was unknown. Additional information has been requested.
dizziness/fainting beginning two days after dose. symptoms resolved at home without intervention. patient has been advised to be evaluated by pcp
Patient developed mild swelling and redness at the site on the afternoon of 11/13/2019 and reported to mother. She marked out boarders and gave him benadryl. Area is sore and redness grew outside of marked boarder since yesterday. Afebrile
Nausea; Diarrhea; sporadic numbness and pain; Dizziness; Immediate numbness in whole arm; continued for 3 days then sporadic numbness; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 at 16:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included eczema, asthma, sunscreen sensitivity, reaction to food coloring (red dye) and allergy to chemicals (cleaning products). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jul2021 at 16:00 the patient experienced numbness in whole arm and dizziness. On 24Jul2021, the patient experienced sporadic numbness and pain. On 25Jul2021, the patient experienced diarrhea and nausea. Therapeutic measures were not taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of numbness in whole arm, dizziness, sporadic numbness and pain, diarrhea and nausea was recovering at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
10 days after varicella vaccine pt had redness, swelling, itching, and axillary nodes at injection site.
SUSPECTED COVID-19 INFECTION; OFF LABEL USE; WRONG TECHNIQUE IN DRUG USAGE PROCESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: bronchitis, chronic sinus infection, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 07-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-DEC-2021, the patient experienced off label use, and wrong technique in drug usage process. On 01-JAN-2022, the patient experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of off label use and wrong technique in drug usage process was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Received Fluarix vaccine.  Approx 1 1/2 hours later felt achy from head to toe; had chills; no fever. No discomfort at injection site.  At home at 5:15 took Tylenol and went to bed.  At 10:00 PM woke up; still achy and cold; took another Tylenol.  10/21/11 at 5:00 AM awoke felt better; but achy all over for about 48 hours.  Acute stage = 12 hours.  Had taken the flu vaccine all of her adult life without problem.
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the 1st dose of the Shingrix vaccine on and had arm pain. The reporter asked some questions regarding the side effects of the vaccine and when she could receive the Covid 19 booster (3rd dose) after receiving the 1st dose of Shingrix vaccine. The reporter did not want to give her contact information and declined to give consent to be contacted.
Signs and symptoms fever, vomiting, dizziness.  Treated 2 L of 0.9% NS, CT ABD/Pelvis.
Extraocular muscle paresis; Facial pain; Vision blurred; Headache; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus, Hypertension, Hypertriglyceridemia and Hypothyroidism. Concomitant products included METFORMIN, TAMSULOSIN, ATORVASTATIN, PREGABALIN, LOSARTAN, LEVOTHYROXINE, TRAMADOL (AC TRAMADOL), CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL COLD&COUGH) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis) (seriousness criterion medically significant), FACIAL PAIN (Facial pain), VISION BLURRED (Vision blurred) and HEADACHE (Headache). At the time of the report, EXTRAOCULAR MUSCLE PARESIS (Extraocular muscle paresis), FACIAL PAIN (Facial pain), VISION BLURRED (Vision blurred) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Computerised tomogram normal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I was ouside on the flight line working on a jet and began to feel light headed and nauseated around 8:40 AM.  I told someone I thought I was having a reaction to the Anthrax vaccine shot I received earlier that morning.  They told me to get in the truck we had with us and he took me to the base clinic where I was helped out of the truck into the clinic.  Once in the clinic they removed my coat and shirt and had me lay down on an exam table. This was around 8:50 AM.  They took my blood pressure and said it was well below my baseline and after I had been there for almost an hour they said it had still not come back up.  The clinic personnel then called an off base ambulance and I was taken to hospital.  While in the ambulance they plugged an IV into me to rehydrate me.  While at the hospital they waited until the entire IV had gone into me and then they took my blood pressure laying, sitting and then standing.  My blood pressure was normal in all three positions, so they discharged me at around 11:00 AM.  The Doctor at the hospital told me not to take the vaccine again since it seems that I have developed an allergic reaction to it.
24 hours after receiving shot, spent the day in bed - very, very fatigued and tired.  1 week later had a day of significant stomach pains.  On the 2nd shot, within 12 hours of the shot became extremely fatigued, slept on/off for the next day, which is unusual for me.
facial numbness; headaches; shooting pain; weakness in my legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "facial numbness"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PAIN (non-serious), outcome "unknown", described as "shooting pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "weakness in my legs". The events "facial numbness", "headaches", "shooting pain" and "weakness in my legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, headache, pain, muscular weakness. Additional information: The patient experienced numerous neurological symptoms (facial numbness, headaches, shooting pain, weakness in legs) since receiving the vaccine and boosters. The patient had numerous studies done, including a temporal artery biopsy and multiple MRIs. No one can identify what is happening. The primary care physician suspected vaccine injury. It is very disconcerting to have these symptoms. The patient has been given numerous medications in hopes of alleviating symptoms and nothing has helped.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Extreme intermittent joint pain. The two days after vaccination, I felt extremely fatigued and achey. That subsided, but the joint pain, while intermittent,  has continued for more than two weeks.
Infant had a one time bloody vaginal discharge.  No treatment given or tests done.  Mom is breastfeeding and had received her COVID vaccine 2 weeks prior and was having a heavier than normal menstrual cycle.
shoulders started to swell; This is a spontaneous report received from a contactable consumer (patient). This 72-year-old patient of unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 19Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported they had received the second dose on 19Feb (2021) and their shoulders started to swell; they inquired how long that was supposed to last, further stating they would call their doctor. The clinical outcome of shoulders started to swell was unknown.   Follow-up attempts are completed. No further information is expected.
MMR vaccine given in (R) thigh at routine physical. Rash, ? hive developed at site immediately. 4 ml of BENADRYL given and observed.
PATIENT DID NOT MEET AGE REQUIREMENT TO BE ELIGIBLE FOR THE PFIZER VACCINE.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with the first dose of MMR II (lot # 641722/0127M) on 23-SEP-2002 and the second dose of MMR II (lot# 651930/1053R) on 29-JUN-2006. No other co-suspects were reported. No concomitant medications were reported. The patient developed bilateral swelling of the parotid glands on an unknown date and was seen in the office on 16-AUG-2012. The medical assistant reported the following lab results from blood work that was performed on 16-AUG-2012: "positive amylase - 495, mumps IgG = 4.62, IgM = less than 1:10 ratio". The patient's mother reported to the office on 29-AUG-2012 that the patient "is all better." No treatment information was given. Additional information is not expected.
Started next morning, took Benadryl. Jittery, migraines, light sensitivity. New heart issues, SOB, dizziness, extreme fatigue.
Sneezing; Congestion with productive cough; Congestion with productive cough; Sore throat; Headache; Low grade fever; Tested positive for Influenza B; This spontaneous case was received on 24-Apr-2023 from other non-healthcare professional (consumer's father) via Agency (reference number: SEQW23-01259) with additional information received (being processed together) on 26-Apr-2023, and concerned a 14-year-old, male patient.  The patient's concurrent condition included attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported.  On unspecified date in early Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration, dose, anatomical location, and indication: not reported). The batch number was not reported.  On unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent the patient experienced sneezing, severe congestion with productive cough, headache, mild sore throat and low grade fever. The patient was being treated with generic Tamiflu (oseltamivir phosphate) and a combination cough syrup.  On 23-Apr-2023, the patient was tested positive for Influenza B.  At the time of initial reporting, the patient was recovering from events with no complications.  The reporter did not provide a causality assessment.  The events of 'influenza B virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 14-year-old patient was tested positive for Influenza B approximately seven months after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient experienced sneezing, nasal congestion, productive cough, oropharyngeal pain, headache, and low grade fever. The patient was being treated with generic Tamiflu and a combination cough syrup. Due to chronological implausibility, the causal role of the suspect vaccine is assessed as not related, since all mentioned events are consequences of Influenza B.; Sender's Comments: A 14-year-old patient was tested positive for Influenza B approximately seven months after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient experienced sneezing, nasal congestion, productive cough, oropharyngeal pain, headache, and low grade fever. The patient was being treated with generic Tamiflu and a combination cough syrup. Due to chronological implausibility, the causal role of the suspect vaccine is assessed as not related, since all mentioned events are consequences of Influenza B.
Rapid and irregular heartbeat, shortness of breath, weakness in legs on 9/8/2023.  On 9/10/2023 & 9/11/2023 I had intermittent chest pain.
Diaphoresis, pallor, sensation  of facial warmth, anxiety, and nausea
Sharp pain in lower right abdomen, which turned out to be Appendicitis leading to emergency surgery to remove the appendix Pain came on very quickly and suddenly just the day before the appendix was removed the next day.  However, now looking back on the entire event, there were  potentially some early signs of pain occurring within one week of getting the first shot on 3/29. The pain came and went over the course of the next few weeks and did not think it would be related to the vaccine. It still may not be but thought it important to report it, in case there is a relationship between them.
Fever, chills, headache, body ache, fatigue, redness on tops of hands
This non-valid spontaneous report was received from a nurse prescriber concerning an unspecified number of patients of unknown age and gender. The patients' historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies, and concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with an unknown number of improperly stored doses of RECOMBIVAX HB (Thimerosal free) reported lot number R006746, expiration date: 09-NOV-2020 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The administered doses of the vaccine, experienced a temperature excursion below 32 Fahrenheit (F) degrees (29. 5 F) for 11 hours, and 32 Fahrenheit degrees up to 35 Fahrenheit degrees (33.4 F) for 8 hours as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was filed.
102 fever; Feels tired; chills; body was aching; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (chills), PAIN (body was aching), PYREXIA (102 fever) and FATIGUE (Feels tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 05-Apr-2021, the patient experienced CHILLS (chills) and PAIN (body was aching). On 06-Apr-2021, the patient experienced PYREXIA (102 fever) and FATIGUE (Feels tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills), PAIN (body was aching), PYREXIA (102 fever) and FATIGUE (Feels tired) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-070301 (Patient Link).
slow anaphylaxis reaction; redness; itching; Initial information regarding an unsolicited valid serious case was received from a pharmacist (reporting on behalf of a consumer) via Medical Information (Reference number- 00541352) and transmitted to Sanofi on 30-Mar-2021.   This case involves patient (age and gender not reported) who experienced anaphylaxis reaction (anaphylactic reaction), redness (erythema) and itching (pruritus), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   In 2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious slow anaphylaxis reaction (anaphylactic reaction), redness (erythema) and itching (pruritus) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  Pharmacist asked what are the excipients in the 2018 FLUZONE QUADRIVALENT HD vaccine. A consumer would like to know. A Pharmacist also wanting to know would having a reaction to the Fluzone High dose affect if get a Covid-19 vaccine. Case resent to PV marking possible hospitalization. The Pharmacist reported that the consumer did go to the hospital either the same day or the next day. There is no more information for the report. Pharmacist asked what are the excipients in the 2018 FLUZONE QUADRIVALENT HD vaccine. A consumer would like to know.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for all events.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a patient (age not reported) who presented with anaphylactic reaction after vaccination with FLUZONE HIGH DOSE. The time to onset was unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Throat tightness, tongue swelling ~30 minutes following vaccine. No hx of anaphylaxis. Symptoms resolved with benadryl
Severe migraine. Took several prescription medications, didn?t work. Went to ER, received several IV medications.
Patient received Johnson and Johnson Vaccine and almost immediately developed a swollen goose egg the size of a baseball at the injection site. Patient was given an ice pack, and after 10 minutes the swelling still had not reduced and she was complaining of pain. The patient was given 50mg of liquid diphenhydramine. After 30 minutes the swelling had reduced some so the patient was told to ice again in a few hours and dose with diphenhydramine again if swelling continued.