chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Non diabetic neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1), administration date: 2021, for covid-19 immunization. The following information was reported: NEUROPATHY PERIPHERAL (disability) with onset 2022, outcome "not recovered", described as "Non diabetic neuropathy". The event "non diabetic neuropathy" required physician office visit. The patient was looking to find information, to see if there is any connection between the COVID vaccine and non diabetic neuropathy. He had 2 vaccines towards the end of 2021 and did not get the 3rd one when it became available. He received them both within a few weeks a part of each other, not quite sure when but, was towards end of 2021.  He had each vaccine in opposite shoulder. He has experienced non diabetic neuropathy pretty much in the beginning of last year, 2022. The event has rapidly gotten worse, was not getting any better. It was in his arms, legs, feet, hands and chest. He had neuropathy test results, maybe Mar2022. Therapeutic measures were taken as a result of neuropathy peripheral. Right now, the only thing they knew to do was vitamins.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event non diabetic neuropathy cannot be excluded based on temporal association and available information. 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.
Case number PHEH2015US022529, is an initial spontaneous report from a nurse received on 02 Nov 2015. This report refers to a 34 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514901) intramuscularly on 28 Oct 2015. On 29 Oct 2015 the patient had a fever of 100.6 F, body aches and sore throat. Body aches and sore throat were resolved; fever was down to 99 F. The seriousness and causality of the events were not reported.
On June 27, 2022 I tested positive for COVID-19. Four days before I had a really bad cold. I had headaches, my jaw was hurting, runny nose, and a bunch of coughing. I ran a low-grade fever the following days.  I contacted my doctor and they sent me a z pack and that did not help so I started taking my asthma medicine to help with my breathing. I kept testing positive for a week and a half.
This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis or with GARDASIL (strength, dosage, frequency, route, lot# and expiration date were not provided). The physician reported that the patient's mother stated that her daughter developed Guillain-Barre syndrome. It was unknown by the reporter if any treatment, laboratory diagnostics, studies or intervention to prevent serious criteria were performed regarding the event. The outcome of Guillain-Barre syndrome was unknown. The reporter did not provide causality assessment  between the events and the suspect therapies. Upon internal review the event was determined to be serious due to medically significant.
Information has been received from a registered nurse regarding an unspecified number of patients of unknown age and genders. For up to three years, approximately in 2010, temperature recordings of up to -3 for ZOSTAVAX have not been assessed. Unspecified doses of ZOSTAVAX have been administered to unspecified patients. At the time of this report, the nurse does not known the patient identifiers and she does not have the specific details to provide. She was attempting to organize the lot numbers, the dates of excursions, the length of time and the temperature out of range, and the dates of administration with patient identifiers. She will collate her data and send it. She would like to know if revaccination is appropriate. No adverse experience has been reported at this time. This is one of several reports from the same source (MARRS # 1312USA010979). Additional information has been requested.
arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200722447 different patient, same drug and event.
Information has been received from a RN concerning a 6 year old female with no pertinent medical history and no allergies who on 07/22/98 was vaccinated SQ in the RL with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06/16/2004 the pt developed red bumps on her hands and face. It was reported that they started as tiny bumps and they got bigger over a course of a few hours. On 06/17/2004 she presented to the doctors office with red, itchy, slightly raised tiny papules to vesicles approximately 1/2 - 1 cm., located on her face, hands, and one on her leg. There were about 15 lesions in total. There was no fever. No Tx or lab studies were required. The pt was Dx with breakthrough chickenpox. At the time of report the pt had not recovered. The report indicated that the pt was sent home to isolate and told to follow up as needed. No product quality complaint was inovlved. Follow up information indicated that the pt returned to the office 6 days later, on 06/23/2004. The pt was thought to have chicken pox. Some lesions had crusted over and some faded away. Now lesions were still coming out. They started as small 1/2 cm barely raised papules and progress ot 1/2-2cm  red papules in a few hours. In about 1-2 days, they crust over or just fade. They are a little itchy. Everything else feels well, she is afebrile and eating well. On exam  she had some old lesions that were now large (2-3cm) and irregularly shaped and scaly. Now 1/2-1cm red papules are on legs, smaller on buttocks. She still has lesions on arms and face, but not on palms, soles, or in the throat. It was noted that there were no vesicles. The Dx was pityriasis rosea vs. papular urticaria. Tx included diphenhydramine hydrochloride ( Benadryl) and calamine lotion. Outcome was not reported. Additional information has been requested.
Onset of pain (L) deltoid at site of Flu immun., has continued and worsened, and spreading. Related to moving shoulder - worsening.
Bruise at site of injection. Rash (2 inch diameter) below site of inject.
Patient was given zoster vaccine instead of varicella vaccine. This was suppose to be the patient's 2nd dose. I have reported error to clinic I care  to my patient care supervisor, and discuss with an provider.
expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Some patients had reported of experiencing flu-like symptoms after receiving the vaccination, but the reporter did not have details of those patients.  No concomitant medications were reported. No treatment information was reported.
sore arm, redness, itching Narrative:  soreness started day of injection redness and itching within a day later
Fever of 99.2 in evening for two nights. Chills then sweating for two nights. Malaise and flu like no energy symptoms. Rash and soreness on injection site for five days. Fever would abate after 1000 mg of Tylenol
chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatigue; tired and lethargic; severe headache; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left deltoid for COVID-19 immunization in hospital. Medical history included allergies; COVID-19 and received her positive result on 22Oct2020, the reporter didn't know if that was pertinent, she was out of work for 15 days. Concomitant medication included lisinopril, clarithromycin (CLARITIN) for allergies, mometasone furoate (FLONASE) for allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her flu vaccine was in Oct2020. The patient received the vaccine on 28Dec2020 and was having side effects. No shortness of breath, but she did have some side effects. She felt fine most of the day. In the afternoon around 2PM (28Dec2020 14:00), she developed a severe headache and took 600mg ibuprofen and it didn't touch it. She took another 600mg of ibuprofen in the evening. She felt tired and lethargic on 28Dec2020 20:00 so she went to bed. This morning (29Dec2020) she had body aches and feels very fatigue. She still has a headache. She has chills and fever on 29Dec2020 08:00. Her temperature was 99.2 degrees Fahrenheit about 2 hours before (29Dec2020). The severe Headache was compared to last night it was better, but she still had slight headache. About tired and lethargic, driving to work she wanted to go to sleep. she was at work at her desk and she was not as tired as before. The lot number was on the card she was given. She was not sure if it was ELO140 or EL0140. No emergency room or physician office was required for any adverse event. The outcome of headache, tired and lethargic was recovering, of chills and fever was not recovered, of body aches was unknown. For events severe headache, tired and lethargic, chills and fever, the seriousness was reported as non-serious, the relatedness was related with COVID vaccine.
Left deltoid was swollen, red, hot, hard extending toward left elbow, seen by Pediatrician.
15 minutes, post vax, pt complained of arms and face tingling. Pt had local reaction of pinkness and slight edema, ice applied. Vitais WNL. No SOB. Pt observed for 2 hours after injection. No further symptoms.
Pt reports evening of 06/23/2011, arm felt very tight "like gripped in a vice" for 2-3 hours, then resolved w/arm movement. No further concerns until 6 days later 06/29/2011 while out of town Rt arm at injection site became very itchy and "pink, some minor skin breaks" after she kept itching it. She also felt her rt arm was "slightly" swollen above elbow, below deltoid. She also c/o of extreme dizziness, weak and faint. BENADRYL relieved itching and sx improved since returning, but still has occasional itching and feels Rt arm still slightly swollen above elbow only when compared to her Lt arm. Today on 07/07/2011 she reached above her head and looked up quickly and "got very woozy and blacked out" and fell against her washing machine. As soon as she looked back down, she regained herself. But now feeling dizzy, weak. She took her BP and pulse at home. BP reported as 96/62 - she says normally 120's/60-70's. Pulse 92. She denies any fevers, HA, chest pain or numbness, vision changes since vaccination. She reports no other vaccinations, no new medications, no new exposures to lotion, soaps, etc...known. Encouraged pt to contact her PMD today about sx and incident for further eval and recommendations. Pt told to call if new sx or concerns develop, otherwise I will FU with her on Mon. 07/11/11. Note: Injection site is still tender to touch but no rash/swelling. 07/11/11 1020 Phone call to patient for follow up. She spoke with provider on 07/08/11 and also had an EKG on 07/09/11. Provider visit told her EKG was normal. At office visit she reports BP was normal. She says provider diagnosed her with Benign paroxysmal positional vertigo and told her likely caused by a "stone in ear" and referred to tx. Not mentioned as a concern w/vaccination. Today, she is doing well. Taking movements slowly. Reports no further swelling in Rt arm - same as lt arm. RD is still tender to touch and has "itchy urge" every so often but doing well. Will continue follow up with provider as directed.
tongue thickness, arm redness & swelling;tightness sounds in neck, no fever p/3rd dose;bitten by a cat;
Pt. received PNEUMOVAX 3/3/16. No reaction at time of injection. Pt. reports that night her arm got red and swollen. Presented to clinic 3/4/16 with Rt. arm swelling, redness, warm to touch, and decreased range of motion in Rt. arm. No fever. Treated with clindamycin and prednisone.
Swollen lymph nodes in armpit in arm that received shot.  Very sore to touch and move.   Swelling and tenderness went from exterior (back) of armpit to interior (front) of armpit near the breast.
Patient reported cold-like symptoms (congestion and sneezing) and was seen for that and for blood in his semen. He was given H1N1 vaccine and was released. The next morning he was found dead of a suspected heart attack.
approximately 10 jminutes after receiving flu vaccine, experienced tingling sensation around mouth, metallic taste and a warm sensation that spread from mouth up through nose.  Given 10cc Benadryl PO (25 mg). BP 120/78       110/78 at 2:35 p.m.
Initially severe pain in left arm. Within 24 hours post vaccine hives on thigh and elbow of arm that received vaccine. By Friday hives had spread to stomach, chest, face and both arms
The first shot was given 7 weeks ago. So we Missed the one month time frame; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The first shot was given 7 weeks ago. So we Missed the one month time frame) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (The first shot was given 7 weeks ago. So we Missed the one month time frame). On 09-Jul-2021, PRODUCT DOSE OMISSION ISSUE (The first shot was given 7 weeks ago. So we Missed the one month time frame) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter.
Developed fever up to 103.7 within 24 hours of vaccine, fever resolved within 24 hours. 48 hours after vaccine developed pink, blanchable, small bumps of forearm. Still present at 72 hours post vaccine.
very sore for 3 days, itchy for like 3 days, hives surounded it like 8 hours after the vacccine and I still have some of them around the site. I took my medications that I have to help with this on a normal basis. It took 3 plous days to get it to stop.
screamed 3 1/2 hrs; listless 4 hrs; slept 12 hrs; moderate local redness @ site;
painful injection site; severe chills; fever; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administration on left arm on 15Feb2021 at 08:15 (at the age of 65-years-old) as single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 on 10Jan2021 and was very sick for 12 days. The patient concomitant medications included acetaminophen. Patient had no known allergies Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 Since the vaccination. On 15Feb2021, the patient experienced painful injection site, severe chills, fever and fatigue. It was reported that, because she had COVID and she was sick, she decided to get the vaccine as soon as possible. She had first vaccine on 15Feb2021 and about 8 hours after vaccine began to have very painful injection site, as well as severe chills, fever and fatigue which resolved in 48 hours. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administration on left arm on 08Mar2021 at 08:15 (at the age of 65-year-old) as single dose for COVID-19 immunization and experienced adverse events. The outcome of the events was recovered on an unspecified date in Feb2021.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021273380 Same reporter,patient,product/ 2nd dose
periodic neck stiffness, leg cramps, some rapid heart rate,memory loss, continual itching on torso and head, not energy and sleepiness after a good nights sleep, low energy.  I am afraid of long term results.  Wish I had not received it
11.2.21 - Hospitalized (still admitted);  COVID-19 positive (11.2.21);  s/p vaccination #1 of series  Diagnosis:  Syncope and COVID-19 Admission Date: 11/2/2021 Discharge Date: 11/6/21 Very pleasant 34 yo gentleman admitted for worsening of ongoing issues with orthostatic hypotension and near-syncope/syncope, now likely exacerbated by COVID infection and  poor oral intake. He has severe malnutrition following gastric sleeve surgery and has lost ~340 lbs thus far (initial weight 713 lbs). Suspect he has post-surgical orthostatic intolerance due to impairment in sympathetic nervous system activity, exacerbated by poor oral intake, especially in light of normal CV ECHO and normal TSH. No significant events on previous Zio patch or on telemetry aside, only occasional asymptomatic bradycardia and sinus arrhythmia. He is tolerating midodrine with some improvement in symptoms, and this can be further titrated as outpatient. Further lab investigation included cytopenias likely due to acute infection, normal AM cortisol. Some micronutrient labs are pending at discharge. We had long conversation about this today with wife participating as well. Am reassured that he does not have evidence of dangerous arrhythmia or structural heart disease. Also suspect a significant contribution from anxiety and he will pursue further management of this with his PCP as well. He feels well from a symptoms perspective, reassured, and is in agreement with discharge and further management outpatient. From COVID standpoint he is doing very well, without hypoxia, did initially have fevers now feeling much better. Received mAb as below.  MD Hospitalist DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Syncope, unspecified syncope type [R55] COVID-19 virus infection [U07.1] HOSPITAL COURSE: Patient is a 34yo male with a history of obesity s/p bariatric surgery, hypothyroidism, and OSA who presented to the ED with a CC of syncope in setting of flu-like symptoms. He was found to be COVID positive. CT venogram head negative for dural venous thrombosis. CTA thorax negative for PE but did show patchy ground glass opacities consistent with COVID infection. He was not hypoxic. He was admitted for further care.   Orthostatic vitals obtained and were positive. He received PRN fluid boluses and oral intake was encouraged. ECHO obtained and unremarkable. Orthostasis persisted despite IVF. AM cortisol and TSH were normal. HbA1c 4.6. He was started on midodrine 5mg tid with improvement of orthostasis though he did continue to have a milder drop with orthostatic vitals. Patient was intermittently symptomatic, but less so than initially and counseled on strategies to use to avoid syncope from orthostatic hypotension. He was discharged home in stable condition. He remained asymptomatic from COVID standpoint.  Patient received MAB infusion on 11/3.
Started with a headache; thought she was having mouth/jaw issues.  Had teeth shaved, purchased a night guard, and wisdom teeth removed.  Headaches continued, over the years symptoms increased to include aches, extreme fatigue, dizzy upon standing, swollen lymph glands, nausea, no appetite and when hungry nauseous after eating, clammy, night sweats, freezing all the time.
After second dose on 4/14, experiencing severe lower back pain unresponsive to prednisone, ibuprofen and acetaminophen
Menstruated cycle that was not scheduled to occur for another 1.5 weeks; Menstrual cycle is accompanied with heavy bleeding and intense cramps; Menstrual cycle is accompanied with heavy bleeding and intense cramps; Vaginal spotting; Soreness at the injection site; Soreness at the injection site and in the shoulder of the arm that was injected; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3303080 [as reported]) via an unspecified route of administration in the left arm on 17Nov2021 at 18:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included multivitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient experienced vaginal spotting for five days beginning on 18Nov2021, the day after immunization followed by a menstrual cycle on 23Nov2021 that was not scheduled to occur for another 1.5 weeks. Menstrual cycle was accompanied with heavy bleeding and intense cramps, more than normal. The patient also experienced soreness at the injection site and in the shoulder of the arm that was injected on an unknown date in Nov2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vaginal spotting was resolved on 23Nov2021; while that of the events menstruated cycle that was not scheduled to occur for another 1.5 weeks, menstrual cycle was accompanied with heavy bleeding and intense cramps, more than normal was not resolved; soreness at the injection site and in the shoulder of the arm that was injected was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.