chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I actually have the same thing happen for dose 1 and dose 2.  Two days after receiving shot I began to experience very significant eye twitching.  This resolved about 4 days after onset. While that went away,  I continue to suffer facial nerve sensation that feels like a tingling.  Sometimes it's in my scalp, sometimes my collarbones, many times my face (especially left side).  I also began to get twitching in the muscle of my arm about 4 months after second dose.  In April I tested positive for CMV. I did not believe I was CMV positive but I am trying to get pregnant and was tested for this as part of the lab work.
Site immediately bruised and bled. She was bruised for more than two weeks and the patient's whole arm was sore during that time also.
Patient received first dose on Janssen vaccine at 6:00 PM. Approximately 5 to 10 minutes later patient asked for assistance from pharmacy staff due to feeling short of breath, wheezing,  throat swelling and feeling hot. Patient received epinephrine 0.3 mg at 6:13 PM and 911 was called. Symptoms immediately began to subsite. It became easier to breathe within minutes of epi. Patient then began to complain of epipen common side effects including a head ache and shaky feelings. Blood pressure and heart rate was monitored. EMS arrived at 6:45 PM and took patient to their vehicle for further evaluation.
Next day, periorbital angioedema. Lasted 1 day. Pre-treated with cetirizine and montelukast for second dose and no symptoms noted.
The patient got a flu vaccine last night and now has significant edema and erythema of his left upper arm.  His brother had a flu vaccine two days before and also had significant erythema and edema.  It has started to go down with Benadryl and cephalexin.  The patient has also had a previous episode of erythema and edema with a vaccination, which was thought to be the polio vaccine.  This same sort of symptoms were present for that. We discussed the ingredients of the flu vaccine and at this point, I do not know what he specifically had that could have caused a reaction.  He has had eggs before and it is unlikely that this is a reaction to eggs.  However, I do not want him to get the injectable flu vaccine any more.  He has had FluMist vaccines in the past.  We will record this as an adverse reaction.  Benadryl is the best thing in the meantime for edema and they will call if it is persisting.
Covid-19 vaccine made patient sick; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Covid-19 vaccine made patient sick) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, On an unknown date, the patient experienced IMMUNISATION REACTION (Covid-19 vaccine made patient sick). At the time of the report, IMMUNISATION REACTION (Covid-19 vaccine made patient sick) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Very quickly had a headache and got very tired. Eventually an extremely sore arm and clogged sinuses developed.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent starting during Oct-2015. The patient experienced possible use of FLUMIST after a temperature excursion to 27F. The outcome of the event of possible use of FLUMIST after a temperature excursion to 27F is unknown. The report was considered to be non-serious.
Dizziness to feeling of fainting @ firs which lasted about 15 mins; No swelling @ site, but warm; No prior vax;
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Information has been received from a registered nurse concerning a 30 month old pt who in approximately 11/99 (at 12 months of age) was vaccinated with Varicella virus vaccine live (site not reported) "Now" on 05/02/01, the pt was diagnosed  with chicken pox. No further details were provided. Additional information has been requested.
pt rcvd vax; pt was cranky for 6 days after vax; t 100/axillary; appetite was good;
Headache; muscle ache; chills; Plus Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 21:45 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19,, lot unknown=False,, administration time=12:00 PM,, vaccine location=Left arm,, dose number=1), administration date: 22Feb2021, for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "Headache"; MYALGIA (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "muscle ache"; CHILLS (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "Plus Tired". Therapeutic measures were not taken as a result of headache, myalgia, chills, fatigue.  Additional Information:There was no other vaccine in four weeks and no other medications in two weeks. The patient had not COVID prior vaccination and also not done COVID tested post vaccination. Patient had no Known allergies. Query reported as a safety unit recently received the attached report submitted by you via URL. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response reported as The date patient became aware was Monday evening 15March.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with no pertinent medical history and no allergies who on 27-APR-2009 was vaccinated IM with the second 0.5ml dose of GARDASIL (lot# 661952/1129X). There was no concomitant medication. The patient discovered that she was pregnant during the GARDASIL series. At the time of reporting, it was unknown when the patient received her first dose of GARDASIL. No adverse effects reported. The patient sought medical attention through an office visit. Blood work-up and ultrasound were ordered. Results were not received at the time of reporting. The patient's last menstrual period (LMP) was reported as 21-MAY-2009. The estimated delivery date (EDD) would be on 25-FEB-2010. Follow up information has been received from a health professional indicated that the patient experienced urinary tract infection during pregnancy and was treated with MACROBID 100mg, which started on 30-JUL-2009 for 7 days. The patient got a shot of flu vaccine on 12-OCT-2009. The patient developed preterm premature rupture of membranes during pregnancy, and on 26-DEC-2009, 31 weeks from LMP, delivered an abnormal male infant (weight 3 pounds 15 ounces, apgar 3/7) (0907USA03082B1). During delivery, the baby was in a breech position and had to have a cesarean delivery. The infant had intraventricular bleed. At the time of the report, the patient's outcome was unknown. Upon internal review, breech delivery was determined to be an other important medical event. The baby's experience has been captured in WAES# 0907USA03082B1. Additional information has been requested.
Early menstrual bleeding/spotting on day 15 of menstrual cycle. Bleeding in this stage of my menstrual cycle has never occurred.
This case was reported by a pharmacist and described the occurrence of cough in a 5-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included bronchitis. Concurrent medical conditions included allergies and asthma. On 11 November 2010 at 15:30 the subject received a dose of FLULAVAL (.5 cc, unknown, right arm) and experienced wrong vaccine administered. On 14 November 2010, 3 days after vaccination with FLULAVAL, the subject experienced cough and sore throat. The subject received FLULAVAL that is indicated for adults only. The subject had been doing fine until Sunday when he complained of a sore throat and a cough. The subject had not had any problems following the vaccine even though it was not indicated for children his age. The reporter stated that the subject went to the doctor and received antibiotics. The reported did mention to the doctor that the subject received FLULAVAL. At the time of reporting the cough and sore throat were unresolved. Follow-up information was received from the reporting pharmacist on 03 January 2011: The cough and sore throat resolved on 18 November 2010. The reporter considered the events could have been associated with a medical condition (asthma). The subject's allergies, asthma, and bronchitis were reported as historic medical conditions.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "Raynaud syndrome" (unspecified if ongoing); "Allergy: Sulfa drugs" (unspecified if ongoing); "Allergy: shellfish/macadamia nuts" (unspecified if ongoing); "Allergies: pollens" (unspecified if ongoing); "Allergies: molds" (unspecified if ongoing); "Allergies: dust" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Positive Covid test 9 days after last Paxlovid.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251564 Same patient, different drug, different event;
muscle pain; prolonged weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 1, single (Lot number: FH8030) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; GABAPENTINE. Past drug history included: Valtrex, reaction(s): "known allergies: Valtrex". No other vaccine in four weeks. The following information was reported: MYALGIA (disability) with onset 23Nov2021, outcome "not recovered", described as "muscle pain"; ASTHENIA (disability) with onset 23Nov2021, outcome "not recovered", described as "prolonged weakness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Negative, notes: Nasal swab. Therapeutic measures were not taken as a result of myalgia, asthenia.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Myalgia, Asthenia  and the use of suspect product cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Dizzy, nausea at 1 hour Throat tightness, felt "swollen" Worked x 2 1/2 hours then reported to nurse, sent to ER
awoke w/stiff neck,itching,erythema,hives between shoulder & elbow;became almost circumferential around upper arm;resolved w/antihistamines;exam-minor erythema;no infect
one syncopal episode; Shaking chills; light headed; pregnant female patient received the vaccine; pregnant female patient received the vaccine; pregnant female patient received the vaccine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional only reported information for the mother (herself). This is the maternal case. A 31-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm, on 11Jan2021 at 08:15 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient's last menstrual period was 05Dec2020 and the patient was pregnant at the time of vaccination (5 gestation weeks) with a due date of 11Sep2021. Concomitant medications, taken within two weeks of vaccination, included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685) on 21Dec2020 at 09:00 (at the age of 31-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced shaking chills, light headed, and one syncopal episode on 12Jan2021 at 01:00. The pregnant female patient received the vaccine on 11Jan2021 at 08:15. The patient did not receive any treatment for the events. The clinical outcome of shaking chills, light headed, and one syncopal episode was recovered in Jan2021 and of pregnant female patient received the vaccine was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the close temporal relationship, the association between the event syncopal episode with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
No adverse symptoms reported; vaccinated wilh improperly stored VARIVAX; This spontaneous report was received from a physician referring to a 4 year old male patient. Information about pertinent medical history, concomitant medications and drug reactions or allergies was not provided.    On 13-DEC-2019, the patient was vaccinated with improperly stored dose(1 dosage form) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S019581, expiration date 25-JUN-2021, route, anatomical location and strength were not provided) for prophylaxis (product storage error). No adverse effects were reported. Administered doses of vaccine experienced temperature excursion from -50 degrees Celsius (C) to -15 C (-14.67C) for 3 hours. Total time in the range from 6 degrees Fahrenheit (F) to 14 degree F (-14 degree C to -10 degree C) (-14.4C) for 3 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint (PQC) was involved with this report.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA006288:
Received Flu shot 11-11-14. Began to develop swelling and discomfort in (R) axilla, clavicle and neck area with low grade fever (+-100 degrees). Feeling generally poorly.
urticaria; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 4 year old female patient who experienced urticaria, while he/she received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 11-Sep-2020, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  In Sep-2020, the patient developed a non-serious urticaria, (unknown latency), 24 hours following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. She went to the emergency room.  Relevant laboratory test results included: Body temperature - [103]  In the emergency room she was given an epipen.  At the time of reporting, the outcome of event urticaria was reported as unknown.
01/4: Moderna Vax?developed headache shortly after injection 01/5: congestion, chills, weakness, body aches He?s taking over the counter meds for now.
11/25 Patient was admitted to the ER/hospital with SOB and weakness that occurred 3 days prior. Patient was hospitalized for NSTEMI (med managed because pt sustained GI bleed from heparin drip so unable to go to angiogram) and Heart failure (diuresed).
Local reaction to KINRIX 5cm x 3cm macule, (L) thigh erythematous, no fluctuance, and TTP noted day after adminisration. Seen by MD in office on 5/30/13. Reassurance, TYLENOL PRN.
Shortly after vaccination client became pale and diaphoretic and fell from chair possible short LOC, weak, HR 68, BP 79/50
I have had brain fog and get dizzy and light headed constantly since the injection. I feel out of it and my vision has been off.
Swelling and mild tenderness of lower left axilla; possible lymph node; developed the day after the vaccine which patient states was "injected roughly".  Pt describes swelling into left chest; was seen in the ER on 4/3-4/3/21, and seen via video visit with me on 4/5/21.
Asthma; copd; struggle with my breathing; This case was reported by a consumer via media and described the occurrence of asthma in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, less than a month after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced asthma, chronic obstructive pulmonary disease and difficulty breathing. On an unknown date, the outcome of the asthma, chronic obstructive pulmonary disease and difficulty breathing were unknown.   It was unknown if the reporter considered the asthma, chronic obstructive pulmonary disease and difficulty breathing to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter was a carer for the elderly person. The patient walked to all calls about 3 months before the reporting date. The reporter had the new flu jab 3 in 1 within 2 weeks and started to struggle with breathing and had been diagnosed with COPD (chronic obstructive pulmonary disease) or Asthma had anyone else had the same sort of reaction to the shot. The patient was always being very fit working 50 to 60 hours per week without any problem.