chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache, fever, arm pain, leg cramps, back pain, nausea, diarreha, swollen lymph nodes in armpit, pain across chest and shoulder blades, extreme fatigue, tired eyes, lack of appetite , brain fog, chills, joint pain
This spontaneous report as received from registered nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with VARIVAX (dosing details were not reported) (lot # L048462 with expiry date of 02-DEC-2017) which was improperly stored at 7 F for a time frame. of 3 hours and 49 minutes, which was having a previous temperature excursion of 28 F for 4.5 hr. The call was made due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
The 58 y/o pt presented first to the clinic on 1/9/08, for complaint of left upper arm pain following influenza vaccination on 12/13/07. On return visit on 1/16/08, she states that the pain has been decreased since last visit. The pain is still  located on the left deltoid area. The pain is dull ache pain in nature. She scored the pain at 2-3/10. The pain is slightly aggravated by elevating and moving the left arm. She denies any fever, chills.   She denies any sensation difficulties in her left arm and left hand. She also denies history of any insect bite and any injury in that area.
Red swollen square shaped area on right deltoid noticed next am after immunization. Mom gave Tylenol as pt c/o pain in that area. Still present at office visit 10/16/06 and painful.
Patient was found to be hypoxic and he required high-flow oxygen. Patient was also found to be COVID-19 positive. According to the patient he was diagnosed with COVID-19 last year. He also to the vaccine this year. He took the 2nd dose back in March of 2021. When I interviewed the patient. Patient had a hard time recalling events and answering the questions directly. He said something about having some fluids buildup for which he had water pills. Patient appeared to be very poor historian about his current condition. He just said that it started 2 days ago to get really worse. He reports generalized weakness and generalized fatigue with generalized pain. He also reported low-grade fever. Nothing made symptoms worsen nothing made his symptoms better.  Patient died on 8/14/2021, cause of death under review.
Arm pain; I was sicker than a dog; If I rub on left arm, site of injection hurts when touched; After the third dose my arm was incredibly sore, I couldn't lift my arm; I had a fever of 102 degrees Fahrenheit; I had chills which lasted 24 to 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm) and PYREXIA (I had a fever of 102 degrees Fahrenheit) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 030L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched) had not resolved and MALAISE (I was sicker than a dog), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) I had a fever of 102 degrees Fahrenheit.         The patient reported that they didn't had any side effects with the first two doses, but they did feel incredibly sore and was not able to lift their arm after the third dose. Reportedly, the patient had a fever, chills, and arm pain and most symptoms had resolved except the arm pain.
Patient reports a couple days after recieving vaccine, having LBP that went to his left side of his stomach, knee pain, rash on left leg, and 4inches of redness at injection site.
pt recv vax 3NOV97 & awoken AM 4NOV97 w/welts on face-non @ inj site or on body;oral DPH giving by mom;MD cont DPH & topical cortisone 10NOV97 resolved;
My CRPs are super high; hs-CRP and the regular CRP are super high; My CRP, regular CRP is 37 and the hs-CRP is 36.6; It is still high; CRP is 18 and the hs-CRP is 17.4; Fever; This is a spontaneous report from a contactable consumer (patient). This 68-year-old male patient received the third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in left arm on 17Oct2021 at the age of 68-year-old for covid-19 immunisation. The first and second dose of Covid-19 vaccine were on an unspecified date, primary Immunization series complete but unknown manufacturer. Medical history included hypertension. Concomitant medication included hypertensive drug. Patient received the third dose on 17Oct2021 and then on 30Oct2021, for a while patient had been experiencing fever at night. So, he run test because he worked in the lab and his CRPs were super high on 30Oct2021. He had hs-CRP and the regular CRP were super high. So, he went to the doctor on 05Nov2021 and doctor told him, it was very unusual because if it was a side effect, it had to be immediate but it took a while for this if it was a side effect but doctor told me and he didn't give him anything and he told him to call Pfizer to report this and he thought that this was the adverse reaction, a delayed one. On 03Nov2021, regular CRP was 37 and the hs-CRP was 36.6. Then he repeated the test (in 2021) and now it went a lot down but it was still high, the CRP was 18 and the hs-CRP was 17.4. EKG was normal in 2021. Patient took TYLENOL because he still had some little fever at night but it was okay now. He took 50 (not clarified) and that was only once in a day when he had fever like symptoms. There was no treatment received for CRP increased. The events required physician office visit. The outcome of events was unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
My temperature is 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (My temperature is 100.2°F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (My temperature is 100.2°F). At the time of the report, PYREXIA (My temperature is 100.2°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) the patient had a temperature of 100.2.         Concomitant products included Lots of prescription medications for an unknown indication.
Information has been received from a doctor of pharmacy concerning a 9 year old female patient who on 04/18/2003 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  By 04/19/2003 in the early AM, the patient had developed pain and swelling in the left arm and "could not bend arm".  Unspecified medical attention was sought, but no tx was given.  By 04/21/2003, the symptoms had resolved.  The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M) (WAES # 0304USA02519, 0304USA02520, 0304USA02521).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
sore arm; This is a spontaneous report from a contactable other hcp. It was reported that the Registered Nurse called as follow-up to previous report she filed on behalf of her wife who is the patient in report 1 of 2.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiry date: Not Provided) via an unspecified route of administration,administered in Arm on 01May2021 as dose 1,Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified day in 2021, the patient experienced sore arm.During that report caller reported information about her-self. The patient in this report is the caller. She reported she had both doses of Pfizer Covid-19 Vaccine and had no reaction other than a sore arm that went away. She had them do the second dose in the dominant arm so the next time it was less of a problem, she could work it. She has not reported this information for herself previously. She reported that is a common occurrence, most injections get that effect, she was not concerned with that and declined to complete report. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiry date: Not Provided) via an unspecified route of administration, administered in Arm on an unspecified date as dose 2, 0.3 mg single for COVID-19 immunization.The consumer asked why they did not put down the dosage information for her first dose; She had an emergency came there agreed to provide her second dose and they put down for dose: 0.3mg for the injection to her arm; she wondered why they did not put that for the first dose. NDC number was not provided.There was not product complaint to the report. There was no medical information request. This wasn't an Other report. Outcome of the event was recovered on an unspecified day in 2021.  Information about lot/batch number is requested.
11 days after the booster I woke up with hives and spontaneous urticaria. After several days of Benadryl with no relief, I started with Zyrtec in morning and xyzal at night and added 20mg of Pepcid of night, vit C and Vit D. The breakouts and less frequent during the day (but still happen), are worse late afternoon and evening. And flare ups start on my face and upper body in morning when I wake up. While it seems more tamed it does not seem like it is resolving.
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 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:19 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 78.43.  No concomitant medications were reported.  Batch number 025L20A administered on 07-Jan-2021 had  temperature 34 from 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported
pt recv vax 19OCT95 & devel cellulitis, characterized by a 2 x 2.5 cm are of redness & induration @ inj site;pt was treated w/Keflex;sx have resolved;
Pain at the site of injection; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the site of injection) and PAIN IN EXTREMITY (Sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of injection) and PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Pain at the site of injection) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
I have experienced severe arm pain, fever, dizziness, fatigue, and muscle pains all over my body.
Was in bed all day crying for mama; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Was in bed all day crying for mama) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CRYING (Was in bed all day crying for mama). At the time of the report, CRYING (Was in bed all day crying for mama) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-317755 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Upon internal review on 12-May-2022, significant correction was performed. The country of incidence was updated from unknown to, recoded the suspect product, events updated, added reporter details and updated the narrative.
Visual disturbances: flashing lights (kaleidoscope vision?) in corners of eyes/peripheral of field of vision. It seems to be mostly in the left eye. It started almost immediately after receiving the injection and remained constant for approx. 5 hours. The next day it was still happening but only here and there, i.e,, sporadically, throughout the day. At the time of this writing, it is 8 days after receiving the injection, and I continue to experience the visual disturbance infrequently. I have discovered that moving my head quickly from left to right will result in the appearance of flashing lights in the peripheral of my left eye.
white patches on their skin/vitaligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VITILIGO (non-serious), outcome "unknown", described as "white patches on their skin/vitaligo".  Additional information: Pfizer had to pay 2.3 billion, the highest amount ever levied against a pharmaceutical company iin the past. Reporter stated that she heard today that someone at Pfizer was arrested for fraud regarding vaccine efficacy and adverse side effects. Reporter queried that "Have they heard any internal communication on that or can they verify the accuracy of that". Reporter also queried that Can "Afib" be a side effect after receiving the Pfizer Covid 19 vaccine, Had that been reported. Reporter stated that her 87 year old husband had a blood clot in his brain after getting the Pfizer Covid vaccine. He couldn't walk and was in the hospital for two weeks and was doing physical therapy now. His doctor said the vaccine could have contributed to it. She stated that she called twice to report it, first on the day it happened when he couldn't walk and then when he was in the hospital. She got a report number but it was "in the other room" and did not provide it. She also said she knew someone who was "paralyzed" after getting the vaccine, someone who had a stroke in the eye, and 2 others who developed white patches on their skin/vitaligo after getting the vaccine. She stated she didn't have their information but she said they all received the Pfizer Covid 19 vaccine.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202101530935 same reporter/product/event, different patient
This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. On an unknown date the patient who was 4 weeks pregnant was vaccinated with GARDASIL injection of 1 vial (route, dose, frequency, lot batch number unspecified). Last menstrual period date (LMP) and estimated delivery date (EDD) were unknown. The pregnancy outcome was pending. The outcome of the event was unknown. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA 8/7/2022 &  1/31/2023 --  RECURRENCE OF SAME SYMPTOMS
Immediately after administration of vaccine, patient fainted. Patient assisted in to wheelchair and wheeled to private observation area. Patient assisted to gurney. Patient has cool compress to forehead.  Patient also nauseous, pale, and sweaty. Patient mother reports patient did not eat today. Given water and apple juice. Patient declined granola bar. Vital signs as follows: 0950-BP 88/59, P 86, RR 20, 95% RA, no pain. 0955-BP 92/60, P 69, 99% RA. 1000-BP 96/67, P 75, 100% RA.  Education given to patient and mother regarding eating/drinking before next dose and to tell the vaccinator that patient passed out at last vaccine and to lay on gurney before second dose is given. Patient and mother acknowledged understanding. Patient back to baseline at 1010.
Pfizer / BioNTech/ Treatment of COVID-19 start: 12Aug2022; Pfizer / BioNTech/ Treatment of COVID-19 start: 12Aug2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recent Breast Cancer Diagnosis" (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 "Pfizer / BioNTech/ Treatment of COVID-19 start: 12Aug2022". 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: Other medication in 2 weeks: No. Patient was received Anti viral treatment as Paxlovid, started on 12Aug2022 and stopped on 17Aug2022 for Covid 19 treatment. Patient has, Head cold symptoms including sneezing, runny nose, stuffy nose. She was mostly asymptomatic prior to Paxlovid except for achy neck and back and fatigue. She took Paxlovid because of a cancer diagnosis. If patient recovered: Recovering and no any treatment for event. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.