chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jul2022 at 00:15 as dose 4 (booster), single (Lot number: FP7135) at the age of 48 years, 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received Paxlovid as treatment of COVID-19.
Pt (4 of 6) reports post vaccine developed fever, inconsolable crying, swelling and induration at injection site that was hot to touch.
I ordered on paper for this 4 month old 1. Pediarix, 2. Pedvaxhib, 3. Rotateq, and 4. meningococcal conjugate Menveo, and failed to give PCV-13.
Local reaction only. 3" x 3". Increased warmth, edema. (This was the 6th dose). DTaP, DTaP, DTaP, DTaP, DT, DTaP. We gave for "P" component. Resolved in 2 days.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. No concurrent condition, medical history or concomitant therapy was provided. On 04-FEB-2016, the patient were vaccinated with improperly stored VARIVAX (Merck) (lot # L025209 and expiration date: 07-JUL-2017, dose and route not reported). No adverse effects were reported. All telephone attempts to obtain follow up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "Body aches"; HEADACHE (non-serious), outcome "not recovered", described as "headaches". Therapeutic measures were taken as a result of pain, headache.  Additional information:Consumer explained that she had her first dose of Pfizer Covid 19 vaccine on 9 SEP 2021 and is scheduled for second dose on 30 SEP 2021. She explained she took two Motrin 17 days later. She noted Body aches and headaches that are ongoing but would not provide specifics. She is concerned. She would like to know how ling would these side effects last and should she get her second dose. Response: Serious side effects that could cause a long-term health problem are extremely unlikely following any vaccination, including COVID-19 vaccination. Vaccine monitoring has historically shown that side effects generally happen within six weeks of receiving a vaccine dose. Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days.Explained she would need to consult her vaccine provider or HCP for vaccine guidance for second dose of Pfizer Covid 19 vaccine. Pfizer unable to provide medical/treatment advice.Question: Consumer took two Motrin 17 days after first dose of Pfizer Covid 19 vaccine. She is concerned and would like to know is this was safe to take after vaccination.Response:These interim considerations state that antipyretics and pain medications (like acetaminophen and non-steroidal anti-inflammatory drugs, like ibuprofen) may be taken after vaccination for treating symptoms, if medically appropriate.Please be sure to discuss any questions about taking a fever-reducing drug or pain reliever before or after vaccination with your vaccination provider, doctor, or other health care professional."Question: Caller explained she is having difficulty hearing from her end.Response: Able to hear consumer. Apologized. Spoke clearly and loud. Agent noted headphone was on and functioning appropriately. Is report related to a study or programme:No.Reporter seriousness for Unspecified event: Unspecified.Reason for no lot number: of Covid-19 Vaccine: Caller unwilling to complete the report.Expiry Date of Covid-19 Vaccine: Not Provided.Other Products: Not Provided. Patient History: Not Provided.Investigation Assessment: Not Provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.; I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.) and VACCINATION SITE PAPULE (I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.) and VACCINATION SITE PAPULE (I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.). At the time of the report, VACCINATION SITE ERYTHEMA (I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.) and VACCINATION SITE PAPULE (I got some light red bumps on my arm about 3 hours after getting the 1st Moderna booster.) had resolved. Not Provided          No relevant concomitant medications were reported.   The patient tolerated the first two Moderna shots well, got some light red bumps on arm about 3 hours after getting the 1st Moderna booster. Those were not painful, and they went away 1-2 days later.  No treatment information was provided.
Moderna vaccine] use for COVID-19 under Emergency Use Authorization (EUA): moderna first vaccine 9/1/21. 9/20/21 had headache and sudden hearing loss in L ear. exam is unremarkable. has history of headaches. traumatic loss of hearing R ear 2011 from MVA.
Left side is numb went down the leg and into the knee.  this went away after a couple days.  BUT Left hand and little finger and next finger are still numb. Tingle like the are asleep.  Stiff in movement.
Within 12 hours of receiving flu vaccine, pt began having subcutaneous swelling in neck bilaterally, but with more edema on side where vaccine was given.  Edema did not cause discomfort. No redness or swelling noted over the site of injection. No pain or pruritis. Edema lessoned over next 24 hours, but continues 4 weeks later. No systemic complaints.
This case was reported by a consumer via out of hour services and described the occurrence of pain in arm in a 67-year-old female patient who received Shingrix for prophylaxis. Concurrent medical conditions included scoliosis (severe) and arthritis. Concomitant products included meloxicam. On 25th September 2018 13:30, the patient received the 1st dose of Shingrix (intramuscular). On 25th September 2018, less than a day after receiving Shingrix, the patient experienced thirst. On 25th September 2018 16:30, the patient experienced pain in arm and injected limb mobility decreased. The patient was treated with Tylenol and tramadol. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the thirst was recovering/resolving and the outcome of the injected limb mobility decreased was unknown. It was unknown if the reporter considered the pain in arm, thirst and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The patient stated that, she received the Shingrix on left deltoid at 01:30 PM and at 04:30 PM, the same day she started to feel the pain in her left arm. The patient stated that, the pain was so severe that she can not move her arm. The patient stated that, she went to urgent care and was taking extra-strength Tylenol and Tramadol. The patient stated that, she was using a heating pad and cold compress for the pain. The patient stated that, she called her doctor and her doctor prescribed Tylenol-3 for the pain. The patient stated that even though she was taking pain medication, the pain was still very severe at the time of reporting. The patient also reported that she experienced extreme thirst that was getting better, but had not completely gone away. This case has been linked to the case US2018176529, reported by same reporter. On 26th September 2018, caller originally left afterhours voicemail with details of this event. An outbound call was placed, to the patient to obtain additional adverse event details.
red, warm rash on right calf and red warm rash on left buttock and left thigh.  Feels almost like a sunburn. Started on 1/13/2021 at around 7:00 am
Triggered uveitis in eyes; Sinus infection; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4500071-00 Regulatory authority.  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160836) at unk, citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "Triggered uveitis in eyes"; SINUSITIS (non-serious), outcome "not recovered", described as "Sinus infection". The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) triggered Uveitis in eyes and Sinus infection of was not provided. Causality as per reporter (Drug/Vaccine) : Not Reported. Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event(s) triggered Uveitis in eyes and Sinus infection of was possible. Concomitant drugs and dates of administration (Exclude those used to treat event). Concomitant drugs not reported.  The reporter considered "triggered uveitis in eyes" related to BNT162b2. The reporter's assessment of the causal relationship of "sinus infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events UVEITIS , SINUSITIS  cannot be completely 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
Patient passed out in lobby. Patient became pale and slowly passed out per father. Patient did not hit head.
pt recvd vax & now has a silver dollar sized hard warm bruised area to lt deltoid area;
This spontaneous report was received from a registered nurse regarding unspecified number of patients whose demographics were unknown. The pertinent medical history and concurrent conditions of patients were unknown. On an unknown date in SEP-2015 unspecified number of patients were vaccinated with unspecified number of improperly stored doses of ROTATEQ (lot # K011948, expiry date 07-JUN-2016; lot # K020181, expiry date 24-JUN-2016, lot # K024700, expiry date 30-JUL-2016) through unknown route. Concomitant medications were not reported. No adverse events were reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 14-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 29-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
weakness; Soreness; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), ASTHENIA (weakness) and PAIN (Soreness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VOMITING (Vomiting). On 09-Feb-2021, the patient experienced ASTHENIA (weakness) and PAIN (Soreness). On 08-Feb-2021, VOMITING (Vomiting) had resolved. At the time of the report, ASTHENIA (weakness) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No symptoms after 1st dose.  15 hours after 2nd dose, patient experienced high fever, chills, muscle soreness, headache for 36 hours.
pt complained of swelling and pain in the shoulder area on  01/15/2021 (corporate level)
Profound sleepiness. Fell asleep and slept for several hours. NOT usual for me. Dangerous if I had been driving or at work.
Chills, headache, fatigue, fever at 12 hours after injection. Headache and fever persisted for 24 hours after onset.
SORE UNDERNEATH THE ARM; HEADACHE; EXTREMELY TIRED; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029, expiry: not reported) dose was not reported, once a total administered on 21-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced sore underneath the arm. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache, extremely tired, and sore underneath the arm. This report was non-serious.
I started to have extremely chapped lips in corners of mouth just after receiving the booster, followed by what appeared to be an oral thrush infection and mouth sores that developed 4 weeks later. After doing research, I initially thought I had angular chelitis. I went to get a topical antifungal to apply to the corners of my mouth, which helped. Luckily I am a Registered Nurse so I knew what to look for to help with a yeast infection. Problem solved? No. I wasn't sure what was happening until I noticed skin peeling off in my mouth, from my inner cheeks and under my tongue. It was really noticeable about 3 weeks ago. I recently moved and could not get an appointment with a doctor until March 23rd. I went to urgent care on 2/16/22 and was prescribed a 7-day nystatin rinse and a one time dose of Fluconazole for an oral thrush infection. Symptoms improved slightly but came back. To this day I am still having the mouth sores and thrush infection. I am very familiar with the symptoms of thrush, I don't know what else it could be. Although this does not seem like the usual progression of thrush, seems to be prolonged. I'm not sure if there are others out there like me who have experienced mouth sores after the vaccine. I am a healthy 24 year old female, I do not take any medications other than birth control, and I haven't been sick since 2020 with some "viral illness" that was tested negative for COVID-19 twice (but i firmly believe I had it because of the outbreak on my hospital unit at the time and I was working on the COVID floor).
PAIN AT INJECTION SITE Narrative:  75 YEAR OLD MALE WHO RECEIVED THE FIRST COVID VACCINE 1/29/21. PATIENT REPORTED PAIN AT THE INJECTION SITE FOR 24 HOURS. PATIENT RECEIVED HIS SECOND VACCINATION 02/19/21.
Intense itching, folllowed by rash on arms, upper body, then large hives
UNKNOWN - Contact w and exposure to oth viral communicable diseases (Primary Dx);  Infection due to 2019-nCoV
large lump appeared under my right arm / The lump covered from the mid part of my under arm to the beginning of my right breast; pulsated pain under my right arm; Lump is about 4" in diameter soft around hard in the middle and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2022 (Lot number: FK9896) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Feb2022 08:00, outcome "not recovered", described as "pulsated pain under my right arm"; AXILLARY MASS (non-serious) with onset 13Feb2022, outcome "not recovered", described as "large lump appeared under my right arm / The lump covered from the mid part of my under arm to the beginning of my right breast"; PAIN (non-serious) with onset Feb2022, outcome "not recovered", described as "Lump is about 4" in diameter soft around hard in the middle and painful". The events "pulsated pain under my right arm", "large lump appeared under my right arm / the lump covered from the mid part of my under arm to the beginning of my right breast" and "lump is about 4" in diameter soft around hard in the middle and painful" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, axillary mass, pain.  Additional Information: 12Feb around 8 am I began to feel pulsated pain under my right arm and the next day a large lump appeared under my right arm on 13Feb2022 of Feb 2 days after I received the vaccine but, the lump covered from the mid part of my under arm to the beginning of my right breast. Lump is about 4" in diameter soft around hard in the middle and painful. I went to the doctor Monday the doctor prescribed me antibiotics Cephalexin 500mg capsules 1 every 8 hrs. for 10days and wants to see me back in 14Mar2022. AE treatment, doctor prescribed Cephalexin 500mg capsules. No covid prior vaccination. Covid not tested post vaccination. Known allergie to latex. Other medical history includes high blood pressure.  Follow-up attempts are completed. No further information is expected.
Large red, round, swollen lump at the site of injection. ZOSTAVAX given 10/5/13.
Patient complained of a raised red rash that was warm to the touch below the site of the injection. She also said she felt fatique and generally did not feel well. Had a fever of 99.7 on 11/5/14 and arm pain as well.
I am the epidemiologist reporting on behalf of 59 year-old female patient.  Patient received two doses of the Pfizer vaccine, according to immunization records. The first dose was on 03/31/21 and the second was on 04/21/2021.  The patient died 4/30/21 (nine days post dose 2) in hospital emergency room (outpatient). The death certificate lists ?cardiovascular collapse? as the immediate cause of death. Interval between onset and death is listed as ?5 minutes.? Known underlying health conditions include (but are not limited to) diabetes.
The night after receiving the first dose, I had hives on my forearm and a rash on my chest. I also had a pain in my right side. The roof of my mouth felt like it was burned. My mouth is still feeling like that. The pain was very short. The hives and rash went away after a few days. I started taking  Benedryl when the rash appeared.
Arms swelled up more; Little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administered in arm right, administration date 20Mar2021 (Lot number: EN6202) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; site: right arm), administration date: 27Feb2021, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome " unknown", described as "Arms swelled up more"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Little sore arm". Therapeutic measures were taken as a result of peripheral swelling, pain in extremity.  Additional information: The patient reported she and her husband both received the second dose on 20Mar2021. They got the first one on 27Feb2021 which they very little to no reaction. The patient's husband had nothing. The patient had a little sore arm, she put ice on it and that was the end of it. But the second time, not that it was anything dramatic that she needed medical care, but her arms swelled up more and it was the first time. She put ice on it. It did not bother her at all. She was able to lift her arm and stuff like that. She received both doses in her right arm. The patient mentioned that when they had the first dose it was a little lower/down to the arm. The second shot was higher up. She doesn't know if that made a difference on that.  No follow-up attempts are possible. No further information is expected.
4/18/2021 at 1:00 AM i woke up with extreme dizziness and was very unsteady while walking at 6:00 Am, the dizziness was worse, the unsteadiness was worse and I had vomited. Had a virtual visit with my doctor who said to take Dramamine for the dizziness. I was not feeling less dizzy until Wednesday afternoon (4/20/2021) - I am still slightly dizzy if I move my head too quickly. I have an appointment with my doctor for later this week.