chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date in 2009, the patient was vaccinated intramuscularly with the first dose of VAQTA (dose, frequency, route, lot # and expiration date not reported) for prophylaxis. On 07-FEB-2017, the patient was vaccinated intramuscularly with an expired dose of VAQTA (dose number, dose and frequency not reported; lot # L031196 and expiration date: 05-FEB-2017) for prophylaxis. Temperature: "36 to 46 F." There were no previous storage excursion occurred for the vaccine per the reporter. No adverse effects were reported. No product quality complaint was involved (PQC). This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA003665.
Information has been received from a Registered Nurse (R.N.) reported that in February 2009 an unknown number of patient may had received a dose of GARDASIL which was exposed to temperature below 2 centigrade multiple times. No adverse effect was reported. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
At bedtime, the day of receiving the influenza vaccine, spike a temp of > 101 and developed SOB. Next a.m. vaccinated arm was swollen: shoulder to elbow, facial and eyelid swelling and reports face was beet red. Self tx: BENADRYL.
Complains of muscle soreness at injection site today which is over a month after receiving TDAp B.  There is no redness or muscle induration.  Complains of red lesions which appear on his hands and have now spread to his forearms after shaking hands or lifting a heavy object. They disappear in a few minutes and are not painful. There is no numbness or tingling associated with the lesions
Patient had reaction within 5-7 minutes after HPV vaccine given - and tdap given after hPV. He turned pale - partially following commands immediately was put on flat position, was breating on his own - checked blood pressure was 130/65 - pulse rate in 60's up to 80 in 2 minutes, O2 sats 95/97 % RA and was better in 5-7 minutes and following commands better. Send by EMS to emergency room. Left there in 1/2 hr with any test after observation.
10 days post Td injection began experiencing cramping stabbing pain left arm on abduction ie reaching for seat belt in car. Pain transitory & does not subside with time. No known trauma.
I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I was tired, and had no smell and slept all weekend.  My arm was very, very sore. The rash lasted until 12/23/2020.
pt recv vax 29APR96 & 3MAY96 12noon devel rash & red sport occur on both legs & face;pt seen in ER t99.9, diffuse macular rash;infected tooth-given amoxil;dx anaphylactic purpura;hosp adm recommended but refused;petechiae purpuric rash
First noticed double vision and blurry vision while driving. A few days later, someone noticed that my left eye was not moving outward and along with my report of having double vision it was decided that I should go to the ER. Tests conducted included CT scan of head with and without contrast, MRI of head, eyes, and neck, ultrasound of neck, EKG, and blood work. Also had two separate series of tests performed by a neurologist. Everything came back normal.  Was sent home and visited an ophthalmologist a couple of days later. Several tests were made and nothing was out of the ordinary, but doctor suggest a left 6th nerve palsy. Referred to neuro ophthalmologist. Appointment is still a few weeks away. Double vision has largely gone away as well as blurry vision. Left eye movement outward is still limited.
At 1028, patient fell from chair to the floor. RN arrived on scene. Patient's eyes were closed for approximately 3 seconds. RN shook patient's shoulders and called out to patient. Patient opened eyes. Patient sat up. Patient was alert and oriented to person, place, time and situation. Patient reported he wanted to lay down on the ground. EMT elevated patient's feet on a chair. EMT assessed patient. EMT noted skin was clammy and pallor of the face. Patient denied hitting head. Patient denied pain, tenderness, redness on head and on left and right knees. Patient reported no history of fainting with vaccinations. Patient reported no chronic conditions, no current medications, and no known allergies. At 1032, assessed patient vital signs: 116/70 mmHg, pulse 88 beats/minute and SpO2 100%. At 1037, EMT reassessed patient vital signs: blood pressure 122/76 mmHg, pulse 78 beats/minute, and SpO2 99%. At 1042, EMT reassessed patient vital signs: blood pressure 120/ 78 mmHg, pulse 76 beats/minute, and SpO2 98%. At 1045, patient was able to stand and sit in chair. Patient denied dizziness and lightheadedness. Patient given water. Patient able to drink water. At 1050, EMT reassessed patient vital signs: blood pressure 118/76 mmHg, pulse 78 beats/minute, and SpO2 98%. EMT educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on v-safe. Patient reported he "feels fine". At 1058, patient left facility with unlabored respirations and steady gait.
PT reports neuropathic pain in her left arm that started right after her influenza vaccine.  Pain has now persisted for two months.
1600 Patient c/o itchiness to  neck and face felt on coming rash 1625 notified me of reaction, advised to take Benadryl 50mg 1630 notified Pharmacist of reaction  1645 follow up with patient "doing okay"  1700 follow  up call feeling the same not worse, leaving work for home, aware to go to ED if symptoms worsens
Patient admitted for motor vehicle accident injuries; was tested routinely for COVID on admission and tested positive on 03/28/2021.
cerebral fluid swelling; pressure; hemorrhage behind the eye; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 45 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 31Oct2021 14:00 (Lot number: 320308d) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. It was unknown if patient received concomitant medications within two weeks. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and has not been tested for COVID-19, post vaccination. The following information was reported: BRAIN OEDEMA (hospitalization, medically significant) with onset 02Nov2021, outcome "unknown", described as "cerebral fluid swelling"; BLOOD PRESSURE ABNORMAL (hospitalization) with onset 02Nov2021, outcome "unknown", described as "pressure"; EYE HAEMORRHAGE (hospitalization, medically significant) with onset 02Nov2021, outcome "unknown", described as "hemorrhage behind the eye". The patient was hospitalized for brain oedema, blood pressure abnormal, eye haemorrhage (start date: Nov2021). The events "cerebral fluid swelling", "pressure" and "hemorrhage behind the eye" were evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of brain oedema, blood pressure abnormal, eye haemorrhage. Clinical course: On 02Nov2021, patient had been diagnosed with cerebral fluid swelling and pressure and hemorrhage behind the eye 2 days following vaccine and stated that never been diagnosed before.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events No follow-up attempts are possible. No further information is expected. 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.
Patient had previous allergic reactions to immunizations but last vaccination 7/15/14 was most severe. Symptoms wouldn't go away & worsened (multiple visits to Dr. & ER) - Short of breath, wheezing, repetitive cough, faint, weak, dizzy, trouble breathing/swallowing, swelling face & lymph nodes, hives over body & redness, itching, vomiting, diarrhea, painful crying & fever.
I got my 2nd Covid vaccine on 4/9/2021. The next day, my arm was red and swollen and itchy. It is still red and swollen and itchy. I have been icing the spot 2 or 3 times a day, which helps for a short time. It is now pretty tender and is mildly sore to the touch.
This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 28-year-old female patient who received RABAVERT (batch number 595011AA, expiry date 31st May 2019. Co-suspect products included RABAVERT (batch number 595011AA, expiry date 31st May 2019). Concurrent medical conditions included cat bite. Concomitant products included IMOGAM Rabies. On 1st December 2016, the patient received the 1st dose of RABAVERT 1 ml. On 4th December 2016, the patient received the 2nd dose of RABAVERT 1 ml. On 3rd December 2016, 2 days after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced itchy rash. In December 2016, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash and itchy rash were unknown. The reporter considered the itchy rash to be possibly related to RABAVERT. It was unknown if the reporter considered the itchy rash to be related to RABAVERT. Additional details were provided as follows: The patient experienced rash which was described as a generalized rash on the patient's arms, legs, abdomen, back and the top of her feet after receiving 1st dose of RABAVERT in her right deltoid. The rash was irregular and itchy. On the same day, the patient also received 1st dose of IMOGAM Rabies. The patient received 2nd dose of RABAVERT in her left deltoid. On 6th December 2016, the patient reported the rash was itching more and she could not go to work. The patient required emergency room visit. The reporter's call was transferred to Medical Information for consultation regarding additional dosing.
dose was not reconstituted with the lyophilized powder; administered the liquid diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 92F7F, expiry date 9th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 28th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 28th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jul-2022 Reporter's comment: The nurse reported that a patient was administered the liquid diluent portion of Rotarix on the day of reporting. The dose was not reconstituted with the lyophilized powder. At the time of reporting, the dose had not been repeated. The reporter consented to follow-up. This case is for 1 of 2 patients. Additional supportive information: The patient was administered the liquid diluent portion of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022112353:same reporter, other patient
stomach hurting; he is not hungry, he does not eat; has lost like 3 poungds but he does not feel critical; Symptoms still ongoing; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurting), DECREASED APPETITE (he is not hungry, he does not eat), WEIGHT DECREASED (has lost like 3 poungds but he does not feel critical), ADVERSE REACTION (Symptoms still ongoing) and NAUSEA (nausea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach hurting), DECREASED APPETITE (he is not hungry, he does not eat), WEIGHT DECREASED (has lost like 3 poungds but he does not feel critical), ADVERSE REACTION (Symptoms still ongoing), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) on 21-Feb-2021 for Nausea and Abdominal pain, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPRIN) on 21-Feb-2021 for Nausea and Abdominal pain, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach hurting), DECREASED APPETITE (he is not hungry, he does not eat), WEIGHT DECREASED (has lost like 3 poungds but he does not feel critical), ADVERSE REACTION (Symptoms still ongoing), NAUSEA (nausea) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-036175, MOD21-036214 (E2B Linked Report).; Sender's Comments:  MOD21-036175: MOD21-036214:
A report was received from a health care professional on 25 November 2003, concerning a 7 month old male vaccinee who inadvertently received Fluvirin on 07 November 2003. On 07 November 2003 the vaccinee inadvertently received 0.25 ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow up pending, all information received. See Ref: PJP200301183, PJP200400053, PJP200400052, PJP200400051, PJP200400050, PJP200400049, PJP200400048, PJP200400046, PJP200400045, PJP200400044, PJP200400043, PJP200400042, PJP200400041, PJP200400040, PJP200400039, PJP200400038, PJP200400037, PJP200400036.
Redness around area where shot was given, swelling that has gotten bigger since shot, and itchy.
Received both doses 11 days apart; A spontaneous report, was received from a pharmacist, concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and resulted in patient received both doses 11 days apart (inappropriate schedule of product administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.     On unknown date, prior to the onset of event, the patient received their second planned dose of mRNA-1273 (Lot number: unknown), intramuscularly for prophylaxis of COVID-19 infection.   The pharmacist reported that the patient received both doses of Moderna COVID-19 vaccine 11 days apart. No treatment information was provided.    Action taken with second dose of mRNA-1273 in response to the event was not applicable.    The outcome of the event, received both doses 11 days apart, was considered as recovered on an unknown date.; Reporter's Comments: This case concerns a male patient of unknown age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting inappropriate schedule of product administration without any associated adverse events.
This is a spontaneous report from a contactable consumer (Patient, self-reported). A 66-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on 05Mar2021 at 13:00 (at the age of 66-years-old), as second dose, single for COVID-19 immunisation. Medical history included arthritis, known allergies to Sulfa. Concomitant medications included lisinopril; valacyclovir [valaciclovir]. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration, in Arm Left on 12Feb2021 at 12:45 as first dose, single for COVID-19 immunisation. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 05Mar2021 at 18:00, the patient experienced explosive diarrhea, lethargy and site soreness. Patient did not received treatment for adverse events. Facility type vaccine: Doctor's office/urgent care. The patients adverse event does not required treatment. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
developed a sore throat with like a limp feeling in it; sore arm; Diarrhea; chills; achy body; nauseas; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (developed a sore throat with like a limp feeling in it), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Diarrhea), CHILLS (chills) and MYALGIA (achy body) in a patient of an unknown age and gender 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 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (developed a sore throat with like a limp feeling in it), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Diarrhea), CHILLS (chills), MYALGIA (achy body) and NAUSEA (nauseas). At the time of the report, OROPHARYNGEAL PAIN (developed a sore throat with like a limp feeling in it), PAIN IN EXTREMITY (sore arm), DIARRHOEA (Diarrhea), CHILLS (chills), MYALGIA (achy body) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
fluid & swelling in trachea & lungs AM-PM 4NOV96;wet cough AM-PM;fever 101.5 PM & chills PM;h/a & less coughing 5NOV96;
This child received Varivax 03/12/97. He had the chicken pox outbreak starting 03/02/01. Approximately 25 lesions.
30 MINUTES AFTER  COVID PFIZER SHOT, PT. C/O  LABORED, SHORTNESS OF BREATH, OVERALL BODY TINGLING; FEELING COLD, ANXIOUS.  1205 VS:  02 SAT:  97%; P:  82, R: 20; 1225:  VS:  02 SAT:  98%; R:  18,  DECREASED SIGNS/SYMPTOMS AND LESS ANXIETY. SENT TO  EMPLOYEE HEALTH, AMB. PER SELF.
Runny nose; Constant cough; Barely can breathe; I have really been sick; This is a spontaneous case received from a contactable Consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration, administered on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced constant cough, runny nose, barely can breathe and the patient has really been sick. Reporter stated, "I had my Covid shot like on last Thursday and ever since Sunday I have really been sick. Like constant cough, runny nose, barely can breathe. Should I go into the emergency room?" The outcome of all the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Aching arm, unable to stretch shoulder and upper arm without pain. Pressure or weight put on shoulder also causes pain. Pain is ongoing and intermittent in severity.
heart condition; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 25-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition". The event "heart condition" required physician office visit.  Additional information: The patient was god child of reporter. The heart condition the patient had that no required surgery was a direct result of her getting the COVID vaccine. She said that 3 separate doctors told her this.   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.
After vaccination on Jan.1 my arm was sore and tender to touch for 3 days and that resolved.   Today, 11 days later, I have a red, slightly itchy, round raised papule on my arm in the area of the injection site.   It measures approx 2" by 3" and has not changed in size throughout the day.  It is not tender to touch.  It did not diminish with application of Triamcinolone cream.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Headache-Severe
Pt with pre-existing transverse myelitis unchanged since 2006-developed a recurrence of transverse myelitis five days after H1N1 vaccination.
PATIENT REPORTED SWELLING OF UPPER ARM FROM ELBOW TO SHOULDER AND WARM TO TOUCH WITHIN HOURS OF RECEIVING VACCINE
Pt called clinic at 3:00 pm-10/25/01 to report neck was swollen-(the middle of neck) had awakened this morning, coughing and founds neck to be swollen-breathing ok-swelling seemed to get worse.  Patient sent Immediate Care  Follow up:  02/26/2002: Since 10/25/01 unable to reach patient, no phone, moved.  Patient has appointment schedule to see how it went to immediate on ER.  Patient did not.  Patient here today for physical.  Patient did not pursue treatment of swollen neck, never any problem breathing.  Symptoms went away over night.    2/26/02-since 10/25/2001-unable to reach pt-no phone and moved. Pt was checked per appt. schedule to see if went to Immediate Care or ER. Pt did not. Pt here today for physical. reports did not pressure  treatment of swollen neck. Never any problem breathing. Symptoms went away over night.
Patient was leaving after her 15 minute time was up and she felt life she could not breath. We checked her BP at 5:50 pm it was 160/94, BP at 5:57 pm was 167/93, BP at 602 was 153/85, BP at 6:10 pm was 156/95, BP was checked on left arm at 6:12 pm was 129/82, BP at 6:16 pm was 134/75 and final BP at 6:19 pm was 144/ 79. Patient stated that she was feeling better and gave her the options to either go home or go to ER. Patient decided to go home with family that was here with her today and they drove.
When supporting his weight or lifting objects, he lacks strength and his range of pain free motion is diminished.