chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ability to regulate their diabetes with insulin was negatively affected; This is a spontaneous report from a contactable consumer. This consumer reported for an 80-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on unknown date as a single dose for COVID-19 immunization at Nursing Home/Senior Living Facility. Relevant medical history and concomitant medications were unknown. Patient was not pregnant at time of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination or if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after receiving the COVID-19 vaccine, it was reported that the patient's ability to regulate her diabetes with insulin was negatively affected. The adverse event resulted in the doctor or other HCP's office/clinic visit. The outcome of the event was unknown. It was unknown if the patient received any treatment for the event. It was not known that since the vaccination, the patient had been tested for COVID-19.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
My arm hasn't stopped hurting since my shot.  I have about 50% strength in that arm and when I move my shoulder beyond certain angles I feel like someone is stabbing me.  The pain has caused me to awake in the middle of the night on several occassions.  My friend is a doctor and he told me that they a nerve was probably hit.  That it would just take time, I told him that was unacceptable.  What if I have permanent nerve damage in my arm?
got the vaccine from Pfizer vaccine in his runny nose was still there but it was better than before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 5 (Booster), Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 4 (Booster), Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 3 (Booster), Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 2, Single), for COVID-19 immunization, reaction(s): "runny nose"; Moderna covid-19 vaccine (Dose 1, Single), for COVID-19 immunization, reaction(s): "runny nose". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "got the vaccine from Pfizer vaccine in his runny nose was still there but it was better than before". Additional information:Caller said that Over the last several years, he had Moderna vaccines. He received all five based on my age. Recently, within three weeks, he got the Pfizer vaccine. While he was on the Moderna vaccine he continuously had a runny nose and everyone in the community did it as well then when he got the vaccine from Pfizer vaccine in his runny nose was still there but it was better than before. He knows that it takes two weeks for the Pfizer vaccine to work. He also had surgery, general week after week and all in his area have mental health problems and he always takes care of his health the covid 19 vaccine helped him immensely, also stated that without the pneumococcal shot, he would have been hospitalized a long time ago and with the third shot of the Morderna he was seriously sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 10/05 I became extremely dizzy, I was nauseas, vomiting, BP was 190/89 I was also feeling week and fatigued. I contacted the Wellness Center at my Living Facility and they recommended that I go to the ER. They called EMS and I was taken to the ER however I was not seen that day because there was a four hour wait. I decided to go Home at that time.
he felt his face warm; his face was red; he thinks he had allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (he felt his face warm), ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included PRAVASTATIN, METFORMIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING HOT (he felt his face warm). 09-Mar-2021, the patient experienced ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction). On 09-Mar-2021, FEELING HOT (he felt his face warm), ERYTHEMA (his face was red) and HYPERSENSITIVITY (he thinks he had allergic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: 75-185 (Inconclusive) 75-185.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient also reported his "RPM from 75 to 185.... he felt okay all the time."  No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-046377 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: the patient stated he took 2nd dose of Moderna and he felt fine with no issues. Denied additional follow-up; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-046377:Husband case
34 patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Date the vial was initially stored in the refrigerator was 4Nov2021. Dates of administration of vaccine was 05Nov2021 and 12Nov2021. The vial didn't undergo any temperature excursions.
Fever 103.2; erythematous macular rash to torso and extremities.
Patient came in for MMR and Varicella vaccinations, reviewed consent form; no history of adverse reactions to previous vaccinations. Patient reports having both vaccinations earlier as child/teenager. Denies any reactions to previous doses of vaccine. Vaccines administered with no complication. Following vaccination about 30-60 seconds patient requested a cool compress. After providing cool compress, patient head of exam table lowered and feet were propped up and patient had syncopal episode lasting approximately 3-4 seconds. Following episode patient was alert and oriented. Patient then monitored in clinic for 15 minutes.
10/30/2020  pt called in, she got a flu shot the other day,  reports arm is sore and such pain- she feels as though it is locked and may be impinging on nerve; 11-09-2020, patient Pt called in to let Dr know she had a flu shot at the clinic, it was given too high in rotator cuff, it is better, she has seen specialist clinic and had injection for shoulder. She is cancelling upcoming surgery due to shoulder and also the COVID cases. She said specialist clinic said the cases are always changing. 11-13-2020, patient 10-28-20 Flu vaccine given by RN under Dr. Injection was given too high. Patient called and states that she was told by the specialist clinic that her flu vaccine is now invalid due to the joint injection and will need a new one. spoke with Dr and he states to call the Health Department in order to confirm this. Spoke with Nurse and she states yes that it would be invalid, 1 that site that it was given, and 2 the steroid injection. She went in and invalidated the injection, and asked us to fill out a Vaccine Adverse Event form.
Began with symptoms of tense headache, nausea loss of appetite and body aches - early morning hours of 4/14/2012. Rash appeared on back and abdomen 4/17/2012 - health department notified of reaction on 4/18/12. Only Tx given was TYLENOL, Dr not seen - 4/18/12 fever down rash more apparent.
sore arm and warm to the touch.  Patient received an undiluted vaccine.  The pharmacist failed to dilute the Pfizer vial so patient received 6x the approved dose
Rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4160649-00 (RA).  A 52 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 07Oct2021 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMIRA (Solution for injection in pre-filled pen) (Adalimumab), route of Administration: Subcutaneous. Daily Dose: Citrate free. Indications for Use: Moderate to severe rheumatoid arthritis. Therapy Dates (From/to): unknown. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "unknown", described as "Rheumatoid arthritis flare up". Therapeutic measures were taken as a result of rheumatoid arthritis. The patient was treated with Plaquenil.  Clinical course: It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Rheumatoid arthritis flare up was not provided. Causality for Pfizer BioNtech covid-19 vaccine (Tozinameran) (Tozinameran): The reporter's causality for the event(s) of Rheumatoid arthritis flare up was reported as Possible.  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 reported information ,a causal relationship between the event rheumatoid arthritis and suspected drug cannot be 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, 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
This Initial spontaneous case was received on 28-Nov-2017, from a consumer, concerning a 34-year-old, adult, male patient. It was reported that, the patient was good and very active. On an unspecified date in 2014 (September or October, 3 years ago), the patient was administered with Influenza virus vaccine polyvalent,  route  of administration: intramuscular, anatomical location: left arm, dose, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2014 (between November and December), the patient developed diabetes. The patient also felt  tired,  could not drink or eat anything, was throwing up and legs were swelling. The patient consulted a physician and was diagnosed with type 2 Diabetes, he was suggested to take unspecified diabetes pills.  Later, the patient was  diagnosed with type 1 diabetes and the medication was changed to NOVOLOG  and LEVEMIR.  The patient also reported that, he had some nerve damage, right above the feet. The patient was admitted for the first time in hospital, on an unspecified date in November or  December 2015 and second time on an unspecified date in July or August 2016. At the time of this report, the patient  had not recovered from the event type 1 diabetes and nerve damage. The reporter considered the events as serious due to hospitalization and assessed the causality as related to the suspect vaccine.
Localized redness and swelling at area of injection (left arm subcu.) Then developed "shingles" on the right back of shoulder on 5/10/17 and was seen in the clinic on 5/11/17 and diagnosed with shingles.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL lot # L000610 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL. Additional information has been requested. Sender's Comments: US-009507513-1708USA005191.
Pain, redness, swelling for 3 + days.  patient prescribed prednisone.
Patient developed diarrhea over the 24 hours after receiving vaccines. Over the next 2 days, she had mucous loose stools and one episode of blood-streaked stools. No periods of inconsolability, vomiting, fevers. Feeding well. When she was seen 3 days after the vaccine, she was still having looser, mucous stools but had not had any further bloody stools.
Itching & swelling at the injection site; systemic allergic reaction; SOB... treated w/ diphenhydramine
8/18: around 1430 vaccine administered; 2030 feeling unwell 500 mg Tylenol given 8/19: 0000 fever 100.8, body aches, and nausea 800mg ibuprofen taken; 0600 previous sxs continue 500 mg Tylenol given; 1700 tongue/mouth painful tongue red ?burned? appearance 800 mg ibuprofen given  8/20: 0700 ha still present, blisters along outter edge of tongue; 1700 vagina noted to be sore  8/21: 0900 ha still present, tongue still burned appearance with blistering, canker sores noted to posterior gum line, dark ulcerations noted to r inner labia with two dark spots noted on left inner labia, 500 mg Tylenol given 8/22: 1100 seen at urgent care due to concerns of worsening mucosal involvement, swabbed for hsv as precaution, provider believes could be vaccine induced reaction  8/23-28: pain peaked on 8/24; epsom salt baths 2-3x/day, ice packs, Tylenol, lidocaine cream 5% 3x/daily, Vaseline prn , peri spray bottle PRN, and rest used as treatment  8/29: lesions mostly healed and no longer using said treatment; seen by dermatologist who believes was fixed drug eruption.
Pt recv vax on 12/10/97; on 12/17/97 pt exp swelling of vax site w/ erythema
Patient reported feeling dizzy and had pain in left arm and leaving his left side paralyzed. He also reported that he talked with his doctor and seeing if it was due to a stroke to rule it out.
On the morning of 2/27/2021, I began having chest pains. I also had body aches, but the most prominent pain was on the left side of my chest. The pain also covered the left side of my neck and the left side of my back with movement. The pain continued into the following day, and my husband took me to the ER at Hospital at around noon on 2/28/2021. I was subjected to a B-type natriuretic peptide test, a CBC autodifferential test, a comprehensive metabolic panel, a lipase blood test, a troponin test (twice), an EKG 12-lead (twice), and an X-ray for chest PA and lateral. I was ultimately diagnosed with stress and told to go home and rest. The chest pains resolved themselves on 3/1/2021.
Pt. received Sanofi Pasteur ADACEL TDAP injection within 5 minutes faint, diaphoretic, clammy, O2 90%. BP 78/42, P 56, vision blurry. EPIPEN administered shortly thereafter BP 100/64 P 64 O2 96% on O2 on. Transported to ED for observation.
Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium
Patient states that within minutes of receiving Tdap he had a very bad taste (metallic) in his mouth and from day 1 - day 4 experienced body aches; sore bones. On a scale of 1-10 day 1 = 10 (pain), day 4 &5. By the 6th day all pain: body aches had ceased. From day 1 X 7 days patient has experienced raspy voice, dry mouth, at night coughs and shortness of breath.
pt recvd vax & had n; fatigue devel over 2 wks; still on & off;
I got covid arm, my periods have been extra heavy and every 14 days no typical for me. Tired all the time
Fever, body aches, intense injection site pain- couldn't lift arm, chest pain, fatigue ( same symptoms as when I had covid)
CASE REPORTED OUT BY DEATH CERTIFICATE,  NO LAB INFORMATION.        DECEASED  2-25-21
Was given vaccines at approximately 9:30 am. At 8:30 pm had a fever and generalized seizure lasting 10-15 minutes. 11/21/06-office note for visit 11/8/06-febrile seizure at home temp 102. Previous seizure . Assessment viral versus febrile seizure.
pt recv vax 13NOV97 4PM & began itching 13NOV97 @ 10PM;noticed considerable inc in itching 14NOV97 about 10PM;pt recv DPYH in hosp ER;cont to have itching & hives for 2 more evenings;no further sequela;
Nausea; Diarrhea; This spontaneous case was received on 06-Oct-2022 from other healthcare professional (nurse) via agency (reference number: SEQW22-04040) with additional information received on 12-Oct-2022 and 13-Oct-2022 via agency (reference number: SEQW22-03395) (being processed together) and concerned a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported. As reported on an unspecified date, the patient had passed and that was not related to the flu injection but to her on going medical condition.  On unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On unspecified date, an unknown time after receiving Flucelvax Quadrivalent, the patient experienced diarrhea and nausea.   The outcome of the events diarrhea and nausea was not reported.  The reporter assessed the events of diarrhea and nausea to be related to Flucelvax Quadrivalent. As reported, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.  This case is linked with cases 202204733, 202204734, 202204735, 202204736, 202204737, 202204738, 202204739, 202204740 and 202205483 (the same reporter).  Company comment: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.; Reporter's Comments: As reported, diarrhea and nausea, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.; Sender's Comments: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.; Reported Cause(s) of Death: One- has passed and that was NOT related to the flu injection but to her on going medical condition
other zoster-related conditions; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, on or about 2017, the patient's pharmacist relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated in emergency department for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles and ill-defined disorder were not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Pt received DTaP and Flu vax on 2-15-17-went to ER on 2-16-17 in febrile seizure, convulsing, abated after took 45 to 1 hr to acknowledge his mom. 3-13-17 in AM convulsed 2-3 minutes. All episodes pt febrile. None lasted >5 min no multiple episodes same day.
4hr p/vax pt had episode of tremors all over, was pale in face & was blue around mouth;episode lasted 20min;mom called 911 & brought pt to ER by amb;
Redness over his right thigh that is also swollen, warm and sensitive to touch. Complaint of slight discomfort.
5cm Rt bicep tenderness, swelling, tingling distally and also headache and nausea/vomiting x2. No errythenia & No fever/chills.
Moderate pruritus, warm to the touch, moderately painful. Treatment: symptomatic measures, OTC analgesics if needed and BENADRYL as needed 10cc/25mg of liquid BENADRYL given in the office.
Upset stomach from the day of shot (not sure of the actual time it started) through Thursday April 8. Felt lethargic the whole time; not usually like that at all. Diarrhea I believe everyday from the day after onward. Cold continually, but no fever or hot. Aches here and there but not continually. Left arm (shot) swelled from right below the shot to almost the elbow. Felt like throwing up two different times. First time did not. Second time (Sunday prior to April 9) threw up bile. Headaches the last few days (I do not usually get headaches unless I am not drinking my water, which I definitely was trying to do). Woke up and got up Friday, April 9 and felt GREAT for the first time since I had my first shot. Second shot was April 20 at 12:30pm. That night had cold (no fever, no hot), next day did not feel great all day and got worse as the day wore on (cold, flu-like); then Friday stomach ache and diarrhea in the morning. Then AOK.
23FEB96 9Pm came down w/fever 103-104 lasted till Sunday evening;other s/sx cranky,slept a lot,ear hurt & bad h/a;did not see pvt MD;family gave erythromycin on sat evening & pt responded better late sunday evening & didn't take to pvt MD