chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician through a Pfizer sales representative. The physician reported for two patients. This is the second of two reports. A male patient of an unspecified age received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced headache. Clinical outcome of the event was unknown at time of this report. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZERINC-2018225112 Different patients, same reporter, drug, event.
Rapid heart beat-lasted 9 days, increased blood pressure meds until it got better shortness of breath-lasted 2 weeks-used inhaler muscle pain-hasn't went away knee pain and swelling-hasn't went away  numbness in right leg-2weeks
C/O burning at injection site, fingers tingling and cold and swollen. Approximately 1 hr after the injection c/o lips swollen and numb. The following day c/o lips peeling. Patient saw her physician later in Nov. No concerns or problems noted.
Pt called pharmacy 1/21/13 to report prolonged side effect from flu shot received on 1/11/13. Reported pain at injection site that would start slow become increased intensity. Radiates outward. Feels like something is trying to get out. Does not radiate down arm. Not tender to touch. No problems moving arm/shoulder. Rates pain 8/10 on pain scale.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had medical problem with needles. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after less than four months of vaccination the patient experienced suspected covid-19 infection, and thought that vaccine was ineffective (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The report was associated with product quality complaint number: 90000216796.; Sender's Comments: V0: 20220224665- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Hospitalized and died. COVID-19 pneumonia. IV Remdesivir and Decadron; IV antibiotics, CCU, BiPap with setting of 16 over 10 with rate 12 and FiO2=80%; Severe sepsis; Acute kidney injury, cardiac arrest.
mild chickenpox, 11 lesions occurred 9JJUL97, fever 8JUL97;
Hib/DTaP/IPV (PENTACEL) reconstituted incorrectly and administered. No adverse event noted.
Patient presents with a diffuse rash on his back and what appears to be hives on his shoulders and chest.
ATTACK OF HYPER OCCLUSIVES; RECRUITMENT TINNITUS; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. 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: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced attack of hyper occlusives. On 02-APR-2021, the subject experienced recruitment tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from attack of hyper occlusives, and recruitment tinnitus. This report was non-serious.
Reaction was bigger; Swollen area at the injection site; Red are at the injection site; Injection site hot to the touch; Little pain at the injection site; A spontaneous report was received from a Consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events little pain at the injection site, swollen area at the injection site, red are at the injection site, injection site hot to the touch, reaction was bigger.  The patient's medical history was not provided. Concomitant medications reported were Virica 75, Axelonol 50 mg, Clonazepam, for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the events little pain at the injection site . On 30 Jan 2021, the patient experienced the events swollen area at the injection site. red are at the injection site, injection site hot to the touch. On 31 Jan 2021, the patient experienced the events reaction was bigger.  Treatment details included Applied Ice  Action taken with mRNA-1273 in response to the events was not reported.  On 22 Jan 2021 the outcome of events little pain at the injection site was resolved. On an unknown date the outcome of events, swollen area at the injection site, On an unknown date the outcome of events, red are at the injection site, On an unknown date the outcome of events, injection site hot to the touch, On an unknown date the outcome of events, reaction was bigger was not reported.  Based on comment,  Listedness is incorrect and should be unknown (Injection site reaction)
On 12/21/2022, I took a trip and noticed others coughing on the plane. On the morning of 12/23/2022, I began to cough as well. I wouldn't have thought anything of it because I have asthma. My brother suggested that I test for COVID-19, and it was positive. The only other symptom I had, was a fever for one day and I vomited once while I was at the doctor's office. I went to a local walk-in clinic because I was out of state at the time. They prescribed PAXLOVID. I took that for 5 days and tested myself again after 8 days and it was negative.
My symptoms occurred approximately  12 hours later. Body temp rose to 102.5, sore all over, and sooooo tired.   Lasted approximately 60 hours.  On 3/12,  I am scheduled for the second dose.  Husband had same vaccine on 3/6/21  with no known side effects.  Sister had same vaccine on 3/9/21 with same similar effects as I; however hers lasted about 30 hrs.
N/A-  Administration error only.  Pt was given a dose of the Pfizer Bivalent Booster after the BUD.
Information has been received from a consumer regarding a 5 year old white male who on 26AUG1998 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two to three weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information was received from a physician which indicated that on 05MAY2003 the doctor's office was called and it was reported that the child had vesicular lesions on the chest, back and axilla. The patient was diagnosed with mild breakthrough varicella which lasted four to six days. The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live. He also indicated that the cases were mild, however he did not know that two of the cases were not mild. No further information is expected.
Patient was having trouble moving his arm and legs, and could not walk. He went to his PCP Dr., who referred him to the emergency department on 10-19-18.
I get a flue shot, I came down with the Flue; Initial information regarding this unsolicited valid non-serious social media case reported by consumer (patient) and transmitted to Sanofi on 09-Dec-2020.  This case involves an unknown age patient who reported get a flu shot, patient came down with the flue (Influenza), while he/she received vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported get a flu shot, patient came down with the flue (Influenza).  Relevant laboratory test was not reported.  Final diagnosis was get a flu shot, patient came down with the flue (Influenza).  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Within two hours: slight nausea, some aches and chills. Within 5 hours severe aches, sore and loose joints, headache, eye lashes hurt (weird, I know), low fever, side of lungs felt heavy and had a hard time breathing deeply.  Inability to sleep for more than 15-30 minutes because it felt like the blood was congealing in place if I stayed in one position (again, weird and not reality, but that's what it felt like). Above severe symptoms lasted 24 hours.  Most of the next day and night I slept. After 48 hours feeling very much improved, but napped multiple times that day.  Third day out just fine, only minor aches.
I have developed debilitating, persistent pain in my left upper arm at the injection site. The pain interrupts my sleep and limits my ability to perform ADLs, such as getting dressed or lifting objects >5 lbs independently. It is provoked by direct pressure and particular motions, such as shoulder flexion and abduction. It has been nearly 3 weeks and the pain has not yet improved with time or conservative measures
Patient received expired medication. Confirmed with manufacturer that dose maintained its efficacy. No follow-up needed. No adverse outcome.
Immunization given on 7/13/12. Reaction started Saturday PM, with swelling at site. Now has area of induration measuring 1x2 inches, surrounded by redness. Area slightly warm to touch. Seen in clinic 7/16/12.
1st week July 2022 your voice started horse and it goes worst in the evening and went to the urgent care and had chills. I was quarantined I was freezing. I test positive and I cant remember the date. Then I had headaches sometime in fall of 2022. I went to my doctor and did a CT scan and it came back negative and it gets worse in the night. I have pain in my back and it feels like arthritis and the doctor will order a sleep apnea test and sleep study.
I had a serve headache, muscle pain, fever of 103, low aplite, and low energy. These lasted for about a day.
Pt developed marked redness and swelling at injection site. Site was tender to touch. Linear vesicles to middle of arm at injection site.
21FEB98 devel low grade fever, cold, cough;23FEB98 ER visit fever 106.1 R;tx w/APAP & Rocephin;LP done;blood work/cult;x-rays, RSV swab negative;pt adm dx pneumonia;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 22-SEP-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23, lot # K007773 and expiration date 01-MAY-2015 (dose, route of administration and anatomical location were not reported). There were not concomitant medications provided. There were no adverse effects reported and no product quality issue was involved.  Additional information has been requested.
soreness in his left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in his left injection site arm.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE PAIN (soreness in his left injection site arm.). At the time of the report, VACCINATION SITE PAIN (soreness in his left injection site arm.) outcome was unknown.            No concomitant medication information was reported.  No treatment information were reported. It was reported that patient had received the vaccine on his left shoulder deltoid muscle. Patient does not recall any other adverse reactions or side effects.   This case was linked to MOD-2022-527836 (Patient Link).
Full body rash across the trunk of the body (stomach, chest, back, neck). Itchy red spots about half a centimeter in size. Began to show up the morning after receiving the vaccine and have gotten worse since. It is now 8 days since the vaccination. It is not spreading to any new areas, but more spots may be showing up and it is increasing in itchiness.
Pt reported back to clinic 1 day after vaccine with redness and swelling (approx. 5 inches diameter) on left arm just below injection site for Hep A & MENACTRA. Pt was seen by a clinic provider 5/26/16 who treated patient for cellulitis with KEFLEX.
Sleepy; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (couple of weeks ago).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, SOMNOLENCE (Sleepy) and FATIGUE (Fatigue) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved.     No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Significant follow-up received on 23-Sep-2021: Reporter details updated, Patient's historical vaccine was added, Anatomical location of the suspect drug was added and Two additional events were added.
Patient received PNEUMOVAX 23, pneumonia vaccine 10:45 AM. He came back around 4:45 PM saying he is having swelling, pain and numbness on his arm.
Information has been received from a female certified medical assistant who was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # not reported).  It was reported that she had pain at the injection site of her second dose of GARDASIL (lot # not reported) series.  The pain lasted a few hours and then resolved.  No further information is available.
Patient received the Covid vaccine on 1/12/2021 at 11:18 am. He felt light headed a minute or two post vaccination. He then lost consciousness for about <30 seconds. The staff eased him down the floor from the chair he was sitting on. He regained consciousness at 11:21am. He was diaphoretic and very pale. BP was 128/73 and HR was 46. Patient was given O2 at 2L/min and Gatorade which he tolerated well. At 11:26 am BP was 121/75,  HR 53, O2 Sats at 99%, and RR 16. At 11:40am, patient stated he felt well and at this time, his color had returned. Patient stated he has a history of fainting with blood draw in 2003 but no issues with vaccines in the past. Also stated his HR usually runs in the 50's range.
Pt has a history of COPD and unspecified liver cirrhosis presenting from outside facility for esophageal variceal bleeding.  Pt tested positive for COVID-19 upon transfer acceptance to a local Medical Center for TIPS procedure.
My menstruation cycle has been 24 to 26 days  and very regular. After the first shot, my period did not begin for 40 days and was spotting.  It lasted 7 days and then a week off and then 5 more days of spotting.  Next cycle was 21 days, pretty heavy and lasted for 6 days.  Four days later, I am spotting.  This is all very abnormal for me.
cold-like symptoms; runny nose; Body aches; sore throat; soreness in the right arm; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), PAIN (Body aches), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the right arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced MYALGIA (soreness in the right arm). On 18-Jul-2021, the patient experienced NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), PAIN (Body aches) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), PAIN (Body aches), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-261598 (Patient Link).
This spontaneous report as received from a medical assistant refers to multiple (unspecified how many) unidentified patients of unknown ages and genders. No information about the patients' medical history, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On an unknown dates, the patients were vaccinated with incorrectly stored doses of VAQTA (lot number M027879, expiry date: 24-JAN-2018 and lot number: M036459, expiry date: 18-JAN-2018, dose and route of administration were not reported). No adverse effects were reported. Digital Data Logger was involved, the storage temperature was reported as 48.52 degrees Fahrenheit in a 20-minute timeframe. On an unknown date. No previous temperature excursion was reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008795: US-009507513-1611USA013978.
I was shoveling snow off of a car and I pulled a muscle, so I went to the hospital and did an X-ray and found that I had Pneumonia again. They gave me anti-biotics and sent me home. Rested for a few days and I started to gradually feel better.
PATIENT DESCRIBED PAIN AT THE INJECTION SITE INITIALLY, WHICH WENT AWAY. HOWEVER, ABOUT 2 DAYS LATER HE DEVELOPED SWELLING OF THE ARM AND HAND.
Client reported already receiving 2 doses of Sinovac only after Pfizer vaccine was administered.
No menstrual cycle since she received the vaccine; This is a spontaneous report from a non-contactable consumer. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in 2021, the patient had no menstrual cycle since she received the vaccine and it had been 2.5 months. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event no menstrual cycle since she received the vaccine was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted and was sweating 10 minutes after injection.  Patient woke up drank some water and orange juice and was fine after 5 minutes
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 4:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.86 for dose administered on 29-Apr-2021.  No concomitant medications were reported. Batch number 007C21A underwent temperature excursion on 29-Apr-2021 with temperature 33 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 29-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
About 15 minutes after the injection approx 10:55am I started felling light headed and slight dizziness,  Its now 3:00 pm  still a little light headed, flushed and feeling tired.  I've not done any treatment for the symptoms