chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: patient was given vaccine around 5:00 pm. after 15 minutes patient complaiend of lightheadidness, 15 minutes later developed slight difficulty breathing followed up throat tightness. after another 15 minutes of no improvement, benadryl was given. after 15-20 minutes, patient began to recover. after another 15 minutes patient was well enough to leave on her own with no further issues.
I have been having more frequent migraine and headaches since vaccination. I have been put on medication to prevent migraines and medication to stop one when it happens.
Pt developed redness at injection site. Lump in arm, nausea for 1 day. Pt has lumps from all three injections.
I was exposed to COVID-19 over the weekend on 05/01/2022. I started getting some septum, nose running, hacking cough, more like a sinus head cold but since I had been exposed by 8 other people and they had also been vaccinated. That prompted me to get tested and tested for positive. I went to get a COVID-19 test on 05/05/2022 at 12:31PM. I am taking Tylenol severe cold and flu, no fever and aches and pain. I have might sound a bit stuffy and coughing a bit up but overall doing much better.
About 4cm x 3cm redness pt was given Augmentin 600/5 1.8cc PO BID x 7 days.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 74-year-old female patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovered", described as "chills after her first dose for 15 mins then it resolved, From the past 3 days she is experiencing chills again but no fever"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "Hands is like ice". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had chills for 2 to 3 days, her hands were like ice, but she does not have fever. her hands were like ice. The patient had experienced chills after her first dose for 15 mins then it was resolved. She wanted to know if she should receive her 2nd dose of the vaccine today, 11May2021 or if she should reschedule it. She also added that she had a blood test last week to check her sugar and its normal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes in right underarm, lymph nodes sore/painful to the touch -- lasted 4-5 days.
My mom went blind the day after she got the flu shot; Initial information received on 18-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who went blind the day after she got the INFLUENZA VACCINE shot.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, Strength, formulation, expiry date was not reported) via unknown route in unknown administration site for Prophylaxis vaccine.  On an unknown date the patient went blind the day after she got the flu shot (blindness) (Latency: 1 day).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This event was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 24-Jan-2023: This case involves an unknown age female patient who went blind the day after she got the INFLUENZA VACCINE shot.The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine(s) cannot be assessed.
Rash on face, localized to chin. Denies pain or other adverse effects. Rash is raised and slightly red. Advised to give BENADRYL PRN itching.
14-year-old male patient complained of increased rectal bleeding beginning yesterday. Has a history of ulcerative colitis (diagnosed November 2021). He has had a mild cough and increased nasal congestion. Patient was hypertensive at 152/69. CBC and CMP significant for WBC of 12.05, SED rate 36, BUN 6, creatinine 0.9, magnesium 2.5, CRP 0.48, and positive COVID-19 swab. Patient received 40mg solumedrol and 1L NS bolus. He was discharged in stable condition on 01/23/2022.
The patient received dose 1 of the COVID Moderna vaccine at around 7:00 AM on 2/8/21 at her place of work The patient came back to the vaccine area around 10:00 AM saying she was experiencing shortness of breath, jaw pain, tingling in her left arm, and chest tightness. Her blood pressure was 188/120 mmHg at 10:05 AM with a heart rate of 105 bpm. The patient said she had had a heart attack a year prior. We called 911 at around 10:12 AM. EMS arrived and took a manual blood pressure of 178/118 mmHg, and took the patient to the hospital shortly after.
2:00 am woke up with teeth chattering, cold chills, body aches  continued to wake up through the night almost hourly in extreme body pain  6:00 am woke up in severe pain, stomach cramping, lower back pain, nauseous, attempted to get myself water and had to sit down in the kitchen in fear of passing out, barely made it back to bedroom before  almost passing out again and immediately broke out in a profuse sweat. Body pain and aches continue for rest of day and into the next.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 14-AUG-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot # J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Developed erythymatous, , induration areas at site of DTaP vaccanation. Area 10 cm x 6 cm increased warmth. No discharge
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Cough-Medium, Additional Details: patient tested positive for COVID-19 on 4/7/2022.
Covid Neuropathy; lumbar radiculopathy; Groin pain; This is a spontaneous report from a contactable other health professional (Pfizer employee) received via COVID-19 Adverse Event Self-Reporting Solution.  A female patient in her 30s received two doses of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  It was reported that the patient received the injection in her arm and was referred to PT (physical therapist) for groin pain also attributed to the injections. She was told she had developed a "COVID Neuropathy" and was treated for lumbar radiculopathy.  Unspecified therapeutic measures were taken as a result of the events. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Neuropathy peripheral and BNT162B2.  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.
3-4 hrs p/shot exp some soreness in lt arm; inc pain in shoulder joint & upper arm muscles x 4 days; worse @ end of day; unable to use arm & end of day p/work;
Administered vaccine at 10:15 AM. At 10:17 AM patient became pale and syncope. Provided Nasal Ammonia Inhalant via nasal. Patient regained consciousness. Doctor assessed patient Pulse: 66 Spo2: 98% . Per doctor provided Gatorade hydration and monitored patient additional 30 minutes. After 30 minutes patient's was stable Vitals Taken: BP: 98/59 mmhg Pulse: 80 Spo2: 100%. Per doctor patient was released home and was notified if any symptoms arise go to nearest emergency room or further evaluation.  Note: patient has history of syncope with blood draws and injections
Redness that is about a dime size or quarter size in diameter in the site of the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The reporter was a pharmacist reporting on behalf of a consumer. Pharmacist stated that generally, with patients administered the Shingrix vaccine, she saw redness that was about a dime size or quarter size in diameter in the site of the injection. This report was for the anonymous group. No other information was provided on this event. This case is linked with US2020019142, reported by same reporter.
Red bumps on right hip area. Also scattered bumps; one on right and one on left butt check, one on left ankle, and one on left lower leg
lymph node swelling in left axilla, left clavicle, left throat, painful some general swelling to left face, possible inner ear swelling, it just feels tight in the ear, watery eye left
Patient unconscious after given Hepatitis A/Varicella/HPV vaccine for 2-3 minutes.
patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up : patient age group and narrative updated.
This spontaneous report has been received from a male pharmacist of unknown age reporting on himself via company representative. The patient did not have pertinent medical history, drug reactions or allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that after receiving PNEUMOVAX 23, the patient experienced injection site pain. None laboratory test were performed. It was unknown if a treatment was given to the patient. The outcome of vaccination site pain was reported as resolved. The causality assessment between PNEUMOVAX 23 and the event was not reported.
On August 19 at 11:00 a.m., pain began in the site where the vaccine was administered. After an hour the site of the arm was completely swollen, hot to the touch, and the child could not tolerate the pain, at 6:00 a.m. PM was admitted to the hospital through the emergency room, because his arm measured 5 cm more than normal, he also had his arm immobilized from pain and high fever (38.4)
Severe cramps similar to menstrual cramps with lower back pain starting 9/12/21, period starting 2 weeks earlier with extremely heavy flow on 9/13/21 (very unusual for me as I am on OCP and I did not miss any days and I've been on this medication since 12/2020). Severe cramping and lower back pain continues to this moment on 9/14/21 along with still having heavy period flow.
Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; No adverse event; Vial was in refrigerator all the time prior to administration; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). Case was created for 3rd of 8 adult patients. No concomitant medication was reported by reporter. Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 2-Aug-2022. No treatment medication was reported by reporter.
Finger swelling on right hand with painful red patches/discoloration of the skin.  Joint pain in fingers of the right hand.
I had my vaccination on 11/14/2021. Within minutes I had developed leg paresthesia left leg immediately after. From hip all the way to my toe. This happened after my first COVID-19 vaccination and this occurs after every vaccination. I have gone to neurologists and battery of tests to no avail.
Information has been received on 01-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a healthcare provider at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
3 yo Female received Pfizer 6m-4 as 1st dose, Moderna 6m-5 as 2nd dose, and received Moderna 6m-5 bivalent as 3rd dose instead of monvalent Moderna or Pfizer Bivalent.
Tingly, achy, and stiff move from joint to joint from neck to fingers down on one side left. duration apprx. one week and still a little stiff and achy. No treatment except Tylenol for pain and heating pad. Still a little achy and stiff
Per patient, symptoms started the day after the vaccine, itchiness is only on his upper body, and dizziness after he left the clinic, per patient no numbness or pain. As of today patient is only experiencing light itchiness, denies any other symptom so far
Chills; Sore arm; Tired; This is a spontaneous report from a contactable consumer.  An adult non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number= EH9899, via an unspecified route of administration on 22Dec2020  (at an unspecified age) as a single dose for COVID-19 immunization.  Prior to the vaccination the patient was not diagnosed with COVID-19. The COVID-19 vaccine was administered at a Public Health Clinic/Veterans Administration facility. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 22Dec2020, at an unspecified time, the patient experienced a sore arm, chills and was tired. The patient was not hospitalized for the events and it was not known if treatment had been given. The patient recovered from the sore arm, chills and tired on an unspecified date in Dec2020. Since the vaccination, the patient has not been tested for COVID-19.
there was an excrusion from freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
Left Arm - bruising, swelling, redness, itching, hot to the touch.  Right arm - rash that includes itching, red bumps, and warm to touch.  I am very  tired. My eyes are cloudy.
Diahrrea immediately following vaccines. Leg couldn't be touched for three days due to extreme pain in injection site. Patient died 5 weeks after vaccines were given.
Increased tenderness to vaccine site, warmth to left deltoid (site) and left axillary tender lymphadenopathy.
5 or 6 inch big bruise on my right arm and then it coming back every week again and going. They are smaller but darker like a black; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 18May2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported) dose 1 via an unspecified route of administration on 27Apr2021 as single dose for COVID-19 immunisation. The patient experienced 5 or 6 inch big bruise on my right arm and then it coming back every week again and going. they were smaller but darker like a black on an unspecified date 2021. Patient stated they had the shot, COVID vaccine on the 27Apr2021 and the second one was on 18May2021 and they gave us the shot we had 5 or 6 big bruise on patient arm, they are smaller but darker like a black hollow and patient had little concerned because it happened to no one else and why it is happening. Patient was unwilling to complete the report. Patient informed about the role of Pfizer Drug Safety and Medical Information Department for the concern and was provided with the contact for Pfizer Medical Information and was informed that the department is open from Monday to Friday, from 8 am to 8 pm and 9 am to 3 pm on Saturday and Sunday as per EST. When asked for permission for further probing, consumer stated No, not right now I am in the rush. Hence, limited information available over the call. Thus, product details (LOT, NDC, UPC and expiry date) could not be probed. The outcome of the reported event was unknown.  Follow-up attempts are completed. No further information is expected.