chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: tested positive again after having tested negative; Positive, notes: tested positive again after having tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medications in 2 weeks. The patient was treated with paxlovid for the events. Treatment start date was 22May2022 and stop date was 27May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Broke out chicken pox 10/04/06. Received varicella 9/14/06.
Pt developed rash on both thighs, redness, swelling, low grade temp. Pt had same reaction with 2 month shots.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Mother called 10-12-14 at 10:08 am. Patient's arm had a red warm hard lump size about 3 x 3. No fever.
sore arm at injection point, fever, muscle aches, chills, sweats, tiredness, trouble sleeping
On 9/26/16, patient claims that arm is still hurting with muscle soreness upon raising arm above shoulder height or stretching the deltoid muscle. He reports thickness of Fluad was more painful than his usual flu injections.
Unwitnessed syncope approximately 15 minutes after injection administration. No headache, chest pain or palpitations. Initial BP 90/58. Monitored patient for 20 minutes. Color improved. BP up to 100/62. Patient discharged home by self.
lightheadedness; hypoglycemia; hypotension; generalized rash; HTN; This is a spontaneous report from a non-contactable other hcp. A 66-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration on an unspecified date (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. The patient medical history included gait abnormal. The patient concomitant medications were not reported. On an unknown date, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) HTN Overall well appearing, not in distress. Patient observed in the bay for approx. 25 minutes. Blood pressure (bp) slowly improving. Patient encouraged to monitor her bp at home. The patient underwent lab tests and procedures which included blood pressure measurement: slowly improving on Bp slowly improving. Therapeutic measures were taken as a result of lightheadedness included water and snacks. Follow up response to treatment was excellent. Patient was stable to go home and follow up with PCP.  No follow-up attempts are possible. No further information is expected.
Client reported that 2 hours after she received her second dose of Covid19 vaccine, she developed heart palpatations, sweating , shaking and her skin became blotchy and red with a rash everywhere. And client reported her arm being very sore and her brain was foggy . She went to the ER and was evaluated and vitals were monitored in the ER. Client stated that she was then discharged and told to take Benadryl and or Ibuprofen for any issues  . Today client reports that she is still not feeling 100% has a sore arm and a migraine.
Developed oral thrush (yeast infection) on day 3.; Rancid taste in mouth developed within 60 mins of first dose; This spontaneous case was reported by a patient and describes the occurrence of ORAL CANDIDIASIS (Developed oral thrush (yeast infection) on day 3.) and TASTE DISORDER (Rancid taste in mouth developed within 60 mins of first dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy. Concomitant products included PARACETAMOL (TYLENOL), IBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.   On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 30-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TASTE DISORDER (Rancid taste in mouth developed within 60 mins of first dose). On 01-Jun-2022, the patient experienced ORAL CANDIDIASIS (Developed oral thrush (yeast infection) on day 3.). The patient was treated with NYSTATIN (oral) at an unspecified dose and frequency. At the time of the report, ORAL CANDIDIASIS (Developed oral thrush (yeast infection) on day 3.) and TASTE DISORDER (Rancid taste in mouth developed within 60 mins of first dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine.  The patient experienced rancid taste in mouth developed within 60 mins of first dose. Reportedly, the patient developed oral thrush (yeast infection) on day 3.   The treatment received by the patient for the adverse event reported as Nystatin Oral Suspension.  The device date reported as 02-Jun-2022.
"Red bump, pain numbness, Heat" per pt. Pt reports redness, swelling and pain with intermittent numbness at injection site for approx 2-3 days following vaccine administration. Presented to clinic 5 days later with touch sensitivity at site. No other complaints. Pt advised to utilize heat/OTC medications as needed. Monitor for new/worsening symptoms and return to clinic as needed.
Hives across chest and upper abdomen (developed around start of symptoms 1800-1830 1/5/21), dizziness, full body aches continuing 48 hours after vaccine received
"Moderna COVID- 19 Vaccine EUA" Patient presented to the vaccination site to receive her 2nd dose of COVID vaccine.  1st vaccine dose received was Pfizer.  @nd dose received was Moderna.  Client returned on the wrong date to receive the 2nd dose.  Patient just complained of feeling tired and drowsy after receiving the Moderna vaccine.
p/Td/MMR/OPV pt became syncopal & stated trouble breathing, BP 82/60 Epi & DPH;
Patient received SHINGRIX 0.5 ml IM on left deltoid last 5/11/18 at 3:30 pm and around 4 pm pt feels weak (at home) that last for a day. And next day he developed sores with burning pain on the corners of his mouth and his teeth is painful and this next day symptoms last for 10 days. And patient also feels feverish on 2nd day but last for a day. Pt didn't go to ER or see his PCP.
After receiving the 2 vaccines patient had a syncopal episode. She was un responsive for ~10 secs. She was then very nauseous and pale. Vital signs were normal. Vomited x2 episodes. After 45 min of observation she still did not feel well and was sent to ER.
Per caller his friend received the Pfizer COVID 19 Vaccine and tested positive for COVID 4 days after the first vaccine; This is a spontaneous report from a contactable physician via a medical information team and Covax Support. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in Jan2021 (at the age of 80-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Per caller his friend and wife received the Pfizer COVID-19 Vaccine and tested positive for COVID 4 days after the first vaccine on an unspecified date in 2021. They were instructed at the vaccine site they would need to restart the vaccine series. Caller asking if that's correct or not. The patient underwent lab test and procedure which included COVID: Positive on an unspecified date in 2021. The outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440874 Same reporter/drug/AE, different patients
This case was reported by a consumer and described the occurrence of flu-like symptoms in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 6 March 2012 and 3 February 2012 the subject received 2nd dose and 1st dose of ENGERIX B (1 cc, unknown details, left arm). For each vaccination, the subject received 2 vials of the listed lot number, which is for a 0.5mL vial, to get a total of 1mL of the vaccine of ENGERIX B. In February 2012, within days of vaccination with ENGERIX B, the subject experienced flu-like symptoms. In March 2012, within days of vaccination with ENGERIX B, the subject experienced flu-like symptoms. In May 2012, 2 months after vaccination with ENGERIX B, the subject experienced sick (described as "chronically sick" and "pretty sick"), chronic fatigue, muscle weakness, nausea, neurological problem, abnormal thinking (described as "problems thinking"), abnormal speech (described as "problems speaking"), and confusion. Per the subject, "the symptoms have come and gone over the past year and a half or so. Some days are better than others, but when it is bad it is disabling." The subject was hospitalized for "these symptoms in September 2012 for 5 days." At the time of reporting the event of flu-like symptoms were resolved. The events of sick, chronic fatigue, muscle weakness, nausea, neurological problem, memory loss, abnormal thinking, abnormal speech, and confusion were unresolved.
Is pregnant: Yes; last menstrual date 23Dec2020; Chest pain; Tingling down arm; Feels like pinched nerve; Feels like pinched nerve and muscle inflammation on left side of chest and around sholder; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Lot number: FC3180) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seizure history" (unspecified if ongoing), notes: Seizure history; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Date of last menstrual period: 23Dec2020. The patient was 34 weeks pregnant at the time of exposure to bnt162b2. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Past drug history included: Cephalex for Known allergies: Cephalex, notes: Known allergies: Cephalex. Vaccination history included: Covid19 vaccine (Dose Number: 1, Batch/Lot No: FA7485, Location of injection: Arm Left), administration date: 30Jul2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes; last menstrual date 23Dec2020"; CHEST PAIN (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Chest pain"; PARAESTHESIA (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Tingling down arm"; NERVE COMPRESSION (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Feels like pinched nerve"; MYOSITIS (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Feels like pinched nerve and muscle inflammation on left side of chest and around sholder". The events "chest pain", "tingling down arm", "feels like pinched nerve" and "feels like pinched nerve and muscle inflammation on left side of chest and around sholder" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chest pain, paraesthesia, nerve compression, myositis.
2 hours after injection left arm began to hurt intensely.  It felt like someone had hit me with a baseball bat.  Developed a high level of nausea and ache over entire body.  Was unable to get much sleep the night of the injection.  Day 2 - generally the same, very tired, still nauseous.
A patient whose age, gender,medical history and concomitant medications were not reported had received a dose of FLUZONE HD vaccine (lot number, route and anatomical site of administration were not reported) on an unspecified date. Within 48 hours of vaccination, the patient developed severe dizziness. Laboratory investigations and corrective medications were not reported. The patient had seen physician who ruled out other causes and attributed it to the FLUZONE HD injection. The dizziness had lasted for 3.5 to 4 weeks. Documents held by sender: None
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-OCT-2013, the patient was vaccinated with ZODSTAVAX (dose strength and route not reported) (lot # J001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality (PQC) was reported for ZOSTAVAD. This is one of the several reports from the same reporter. Additional information has been requested.
After 24 hours post vaccination I had severe headaches, nausea, and vomiting that wouldn't allow me to drive and so I had to take a next day off work. Monday, day 2 post vaccine, my headache and nausea continued to be an annoyance and I suffered from a lot of fatigue that caused me to go to bed almost immediately after work for the remainder of the week. I tried to sleep in during the weekend however when speaking with healthcare professionals they had no answers for my symptoms. I am now starting to feel a lot better, and my nausea has gone away however my headache comes and goes.
A report has been received from a Health Professional concerning a 6 year old female patient received FLUMIST (intranasal), 0.2 Milliliters, unknown. FLUMIST (intranasal) started on 09-Nov-2015. The patient experienced fever which started on 10-Nov-2015, coughing and congestion which started on 09-Nov-2015 and positive influenza rapid diagnostic A/B test which started during Nov-2015. FLUMIST (intranasal) was continued. At the time of reporting, the event coughing, congestion and fever was ongoing and the outcome of the event of positive influenza rapid diagnostic A/B test was unknown. The report was considered to be non-serious by company physician.
Vaccine was given on 9/2/2020, but the vaccine was one day expired with expiration date  9/1/2020.
Patient was starting COVID -19 vaccine series with Moderna. Should have recieved monovalent dose, but instead was given bivalent dose. No adverse outcome with patient. Patient should be re-vaccinated with primary dose series as soon as possible. Provider notified patient's parent.
The patient stated that three days after receiving the vaccine she developed a rash on her arms and chest. She used OTC Benadryl and the rash went away on Tuesday. She then experienced dizziness and nausea which went away the next day with the use of OTC meclizine. As of Wednesday the patient was symptoms free.
Pt developed redness, swelling, itching, and pain at injection site. Pt went to Dr on 10/5 and was prescribed antibiotic for cellulitis. Symptoms continued to progress but as of 10/7 symptoms have begun to improve.
painful headache; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated he had called regarding the Pfizer Covid 19 vaccine. The caller only wanted to ask simple question whether he could take Advil if he was experiencing a headache. Stated that it was a painful headache. He asked whether taking Advil or Tylenol would reverse the effects of the vaccine. Mentioned he would just figure out and take it himself. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt had a mild injection site reaction and suffered flu-like symptoms for 48 hours post injection. Symptoms had fairly rapid onset. Pt informed me on 2/16/16.
pt recvd vax 1NOV91 in AM to hosp 1NOV91 1045PM w/coughing, & fever 104 R; MD gave APAP & pedialite parents told probably rxn to vax; next noc 2NOV91 to clinic w/cough & temp; mom states pt ill next 2 months w/bronchitis, pneumonia & virus;
Took a nap and woke up with a black eye, left side.  Occurred approximately 1430 on 01 January 2021. Black Eye continued to spread downward to the check bone.  Visited Urgent Care on 1/11/2021 and they said it was due to a broken blood vain.  I have never had this incident in the past.
chills, body aches, headache, abdominal pain, nausea, vomiting
Fatigue; Malaise; Minor arm pain; 101.7 Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration on 19Mar2021 at 15:30 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), hypothyroidism, PCN (penicillin) allergy, codeine allergy and Sulfa allergy. Concomitant medications included BYSTOLIC, Losartan/HCTZ (MANUFACTURER UNKNOWN), SYNTHROID and milk thistle (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: E19267) via an unspecified route of administration on 16Feb2021 at 16:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 09:30, the patient experienced fatigue, malaise and minor arm pain, 18 hours post vaccination and experienced 101.7 fever and chills, 29 hours post vaccination. The patient did not receive treatment for fatigue, malaise, minor arm pain, fever and chills. The clinical outcome of the events fatigue, malaise, minor arm pain, fever and chills was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
head cold; Experienced really bad heart pain an hour ago; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Experienced really bad heart pain an hour ago) and NASOPHARYNGITIS (head cold) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMITRIPTYLINE, ERENUMAB (AIMOVIG [ERENUMAB]) and FLUDROCORTISONE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSPEPSIA (Experienced really bad heart pain an hour ago). On an unknown date, the patient experienced NASOPHARYNGITIS (head cold). At the time of the report, DYSPEPSIA (Experienced really bad heart pain an hour ago) and NASOPHARYNGITIS (head cold) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received included new event head cold and outcome for the event dyspepsia was updated to recovered.
NO APPETITE; BAD FLU; JOINT ACHE; NAUSEA; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced no appetite. On 08-APR-2021, the subject experienced bad flu. On 08-APR-2021, the subject experienced joint ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, and joint ache on 09-APR-2021, and bad flu, and nausea on APR-2021. This report was non-serious.