chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe dizziness, numbness in legs, bad chest pains, contractions in stomach, no appetite, nauseated, muscle spasms, legs locking up, had to have help, intense pain travels all over body (back, feet, legs, hip, lower back, esp. head), couldn't get up and down without help.
after pt received 1st dose of covid vaccine, pt started having increased shortness of breath.  he went to see his PCP and his PCP prescribed inhaler for him since his PCP thought it was due to his asthma exacerbation.  but the inhaler didn't help.  Shortness of breath worsened and pt started to have yellow/white phlegm.  he came to ED for further evaluation. he was very hypoxic and tachycardic.  per chart, he was noted to be mottled from his lower extremity up to his abdomen.   BNP and troponin elevated.
just had to go to bed and sleep it off; spells of feeling car sick; nausea; swimming head; way worse than just feeling dizzy; soar arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soar arm), MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head) and DIZZINESS (way worse than just feeling dizzy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (soar arm). On 01-Feb-2021, the patient experienced MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head) and DIZZINESS (way worse than just feeling dizzy). On 05-Feb-2021, the patient experienced SOMNOLENCE (just had to go to bed and sleep it off). On 26-Jan-2021, PAIN IN EXTREMITY (soar arm) had resolved. At the time of the report, MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head), DIZZINESS (way worse than just feeling dizzy) and SOMNOLENCE (just had to go to bed and sleep it off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient came in to see PCP the day after prevnar 13 injection (injection placed on 5/9/19 and patient RTC with swollen left shoulder on 5/10/19). Pt stated that it felt like there was a ball going up left shoulder. Pt reports she had a fever of 101 the night of May 9th, then took tylenol in the morning to help with pain and fever. During 5/10/19 office visit, patient stated feeling  some shortness of breath due to the pain, like she could not take a deep breath. Pt denies chest pain, and sick contacts.   Impression and Recommendation by Dr.: - "Exam consistent with acute bursitis, likely secondary to vaccine. This inflammation may be causing increased fevers as well, although anticipate would be short lasting CBC reassuring that not acute infection XR without specific pocket of inflammation,"  Reviewed likely vaccine complication with patient and expected course of recovery. Apologized that this event happend for pt and explained adverse event reporting system, will follow up with RN team to file. Anticipate that fevers will resolve within 1 day as will most swelling Reactive bursitis may have persistant pain for 2-6 weeks.  Advised tylenol and ibuprofen alternating over the 48 hours with ice. Advised that if fevers persist longer than 24 hours, if SOB worsens or if pain much increased, should come to clinic or ED for further evaluation Pt in agreement and reiterated understanding of the above plan.
I started with tingling in lower limbs (legs), in the following days tingling also occurred in the upper limbs (hands) presenting numbness in extremities subsequently I started with spasms (itching) and pain in legs, arms, then tingling sensation and itching in the head, head pain, dizziness, blurred vision. Currently I have complications when walking and moving, pain, numbness and tingling in the body that prevent me from performing my daily activities.
Describe Event, Problem, or Product Use Error; This report is to address queries sent on 23NOV2020 regarding this initial report. 1. Please provide final diagnosis (SAE verbatim) along with causality; Anaphylaxis 2. Was the events occurred due to flu vaccine ? Do you consider flu vaccine as co-suspect ? if yes plz provide details with causality: The study physician believes that once the participant's immune system was challenged with the flu vaccine, she started developing antibodies and therefore a cross reaction that ended up escalating to a strong reaction either to the flu vaccine itself or combination of her sensitivity to the NRTs and now her overactive immune system. 3. Provide other possible causes if any: Possible sensitivity to "medicinal nicotine" as it is purified and not mixed with tobacco as it is in the smoke of cigarettes, however the physician feels this is unlikely. Another possibility the physician noted is that the participant is sensitive to the vehicle in NRTs (matrix of lozenge, or the adhesive in the patch), but that she is not necessarily allergic to them as she had been on them in the past and even though she had a variety of reactions to different brands, she never had an anaphylactic reaction but rather minor local reactions. 4. Treatment medications: Benadryl, prednisone and famotidine
Client reports itching in hands, feet, elbows and other joints, intermittent, reports very intense.  9-10 scale of 1-10 with 1 being tolerable, 10 being intense.  States began on 2/26/08.  Only took 2 typhoid capsules, stopped when complaints began.  Also reports itching and redness of ears.  Denies swelling or fever.  Instructed to contact physician.
rhabdomyolysis following receipt of BNT162b2-V; Chest pain; Patient accidently received a triple BNT162b2-V dose (undiluted dose) and developed chest; Patient accidently received a triple BNT162b2-V dose (undiluted dose) and developed chest; This is a literature report.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHABDOMYOLYSIS (medically significant, life threatening), outcome "unknown", described as "rhabdomyolysis following receipt of BNT162b2-V"; CHEST PAIN (medically significant), outcome "unknown"; PRODUCT PREPARATION ERROR (medically significant), OVERDOSE (medically significant), outcome "unknown" and all described as "Patient accidently received a triple BNT162b2-V dose (undiluted dose) and developed chest". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: 7000 IU/l.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-PV202200056097 Same article/ drug/event and different patient;
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The nurse reported that on unknown dates, the patients were vaccinated with doses of improperly stored (Data Logger; under 50.4 F for 11 hours and 50 minutes, and previously at a lowest temperature 33 F for 838 hours and 59 minutes RECOMBIVAX HB (lot # K014548 with expiration date: 27-AUG-2016; dose and route not reported. No adverse effects were reported. Additional has been requested.
11/09/05 3:30pm began to feel chills and body aches upon returning home felt stiffness in neck muscles. T-101.5F. 4am sweats upon arising  felt fine but weak. 11/10/05 am felt itching on chest and back, no rash visible. 11/11/05 Friday am asymptomatic none of the s/s were presented in the health services dept.
J18.9 - Pneumonia of right middle lobe due to infectious organism E87.1 - Hyponatremia
She went to a walk in clinic for cellulitis of the left arm. The doctor told her it was 20cm x 20cm and indurated. She showed me the arm that had been injected, and there was a large red area.  She also experienced a low grade fever, muscle aches, and headache. The doctor sent her to the pharmacy with a prescription for Keflex.
flu after getting flu shot, with temperature 103; Initial information regarding an unsolicited valid non-serious social media case through global digital media received from a non-health care professional (HCP) (patient's grand parent)  on 07-Dec-2020.  This case is linked to case 2020SA353074.  This case involves Adult male patient who flu after getting flu shot, with temperature 103 (Fever), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site.   On an unspecified date, (latency unknown) after the administration of vaccine, the patient reported flu after flu shot with temperature of 103 (fever) (units and normal range not reported). It was also reported that flu shot can be worse than the actual flu.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information regarding the batch number of the case.
This spontaneous report was received from a medical assistant (also reported as a nurse) and refers to an unspecified number of patients of unknown demographics. No information regarding patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, patients were vaccinated with ZOSTAVAX, subcutaneously (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) for prophylaxis. The medical assistant reported that the office ran out of the sterile diluent (manufacturer unknown) and used a sterile water (manufacturer unknown) to reconstitute the ZOSTAVAX vaccine, on unknown dates. No adverse event was reported. Product quality complaint (PQC) was not involved. The outcome of the reported event was unknown. This is one of four reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA010521:
Stomach is "different", suddenly has to go to the bathroom; Fatigue; Appendicitis; Stomach pain / Stomach upset; Indigestion; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Appendectomy on 20-Apr-2021. Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain / Stomach upset), DYSPEPSIA (Indigestion), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). On 13-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach is "different", suddenly has to go to the bathroom). The patient was treated with Surgery (Appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (Appendicitis), ABDOMINAL PAIN UPPER (Stomach pain / Stomach upset), DYSPEPSIA (Indigestion), PAIN IN EXTREMITY (Pain in arm), ABDOMINAL DISCOMFORT (Stomach is "different", suddenly has to go to the bathroom) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Computerised tomogram: revealed appendicitis Revealed appendicitis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took Pepto-Bismol (bismuth subsalicylate) and laxatives for stomach pain and indigestion.   She had appendectomy on 20-Apr-2021. She now reports that her stomach feels 'different' and she has sudden urges to go to the bathroom.  Treatment information was not provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
redness at the injection site; Tenderness of the injected arm; redness below injection site; soreness below injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, erythema of extremities and pain localized. On 3rd October 2022, the outcome of the injection site erythema, injection site pain, erythema of extremities and pain localized were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, erythema of extremities and pain localized to be related to Shingrix.   Additional Information: GSK Receipt Date:01-OCT-2022 and 03-OCT-2022 Reporter's Comment: The patient Shingrix administered to unspecified arm.  The patient wanted to know if it was common to have redness and soreness at and 2 -3 below the injection site. The patient stated that, it was still sore and red at the above locations. The reporter did not have the lot number of the Shingrix which was administered. But did provide the contact information for the pharmacy where the shot was administered reporter gave consent for safety to reach out to his doctor though he mentioned that, he had not seen the new doctor yet as he had to recently switch doctors. The patient stated that, he looked at his arm this morning (3rd October 2022) and it looked fine.  There was no redness at the injection site or below the injection site (anymore). Also the tenderness (soreness) of the injected arm had resolved.
Extremely overactive bladder.  More than 4 times that night. Same happened to my breast fed toddler. Next morning her bladder kept emptying.
arm swelled; arm turned bright red; This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included iron (Feosol).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 77 or 78 years. The patient reportedly experienced her arm swelled and turned bright red. No other information was available. The reporter had not consented to follow up.
CC said that consumer was calling to report symptom; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (CC said that consumer was calling to report symptom) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (CC said that consumer was calling to report symptom). At the time of the report, ADVERSE REACTION (CC said that consumer was calling to report symptom) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medication were not reported.
Within 2 days, the pt developed a "severe" injection site reaction characterized by swelling and redness. "which wrapped clear around to axillary area" and a low grade fever.
pt recv vax 14MAR96 & 23APR97 pt devel an afeb varicella-like rash that consisted of 80 lesions;in f/u it was reported that pt had chickenpox
Narrative:  Patient received Moderna COVID vaccine #1 on 3/9/21 and #2 on 4/6/21. No other notes or scanned records are available and date of death is recorded as 4/8/21. No autopsy report available. Time between second vaccine and date of death is 2 days.
Experienced redness at the injection site, that turned purple; Experienced redness at the injection site, that turned purple; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site discoloration. On an unknown date, the outcome of the injection site erythema and injection site discoloration were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 62 or 63 years. The patient received 2nd dose sometime in 2018 specific date unknown and experienced redness at the injection site, that turned purple. The reporter did not consent to follow-up.
begin to see faces one at a time/become grotesque looking and scary looking/hallucinations; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8727), via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had one dose of the Covid vaccine and was supposed to have the second one on the day of the report. She was not sure whether or not to get the second dose. She felt okay after the first dose. She read all the information about side effects and said they were all general side effects and said that the information did not include the unusual side effects. The patient stated that when these happened to her she didn't relate it to the vaccine at first. The patient stated that when she would lay down at night to sleep and close her eyes she would begin to see faces one at a time. They would then become grotesque looking and scary looking. This happened a couple of times, over a couple of days, right when she would close her eyes. The patient mentioned that she had the light on in her room because she always has the light on in her room. The patient asked if is was a side effect people are having. She saw on the internet that it could be a side effect of vaccines. She mentioned it to a friend who told her that she was having hallucinations.  She looked online and it said vaccines can sometimes cause hallucinations. She said she read online about one person who said that after their second dose they had bad hallucinations like as if they were on mushrooms. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
PT states that she felt "tingly all over". Then she felt her heart racing and throat felt "different". BP checked 100/70, pulse 88. PT continue to feel different in her throat. Agreed to take 25 mg of Benadryl, given at 11:10.  911 was called, patient signed refusal to be evacuated. Patient stayed under the watch of the medical staff until 11:43 when she said she felt fine again and left.
Case number PHEH2015US019568, is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 47 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) at a dose of 0.5 ml intramuscularly on 23 Sep 2015. It was reported FLUCELVAX was at room temperature for 24 hours before administration. No adverse event was reported.
Headaches severe; tiredness; body aches; dizziness; lethargy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), LETHARGY (lethargy), HEADACHE (Headaches severe), FATIGUE (tiredness) and MYALGIA (body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff tear, Arthritis and Knee replacement. Concurrent medical conditions included Osteoporosis, COPD, Hypertension, Drug allergy (Melaxicom) and Drug allergy (tramadol). Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), IRON and PANTOPRAZOLE for an unknown indication.    On 17-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches). On 18-Aug-2021, the patient experienced HEADACHE (Headaches severe) and FATIGUE (tiredness). On 21-Aug-2021, DIZZINESS (dizziness), LETHARGY (lethargy) and MYALGIA (body aches) had resolved. At the time of the report, HEADACHE (Headaches severe) and FATIGUE (tiredness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product also included Vitamin D4. No treatment medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow up was received and patient details, relevant medical history, concomitant products and events were updated.