chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister.   A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation.  Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported.  In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine.  Information on the lot/batch number has been requested.
Fever; chills; night sweats; body aches; headache; fatigue; huge bruise near injection site, easy bruising; This is a spontaneous report from a non-contactable nurse, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 13:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included ovarian cyst and known allergies to cinnamon. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cetirizine hydrochloride (ZYRTEC), paracetamol (TYLENOL) and naproxen sodium (ALEVE); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 03:00, the patient experienced fever, chills, night sweats, body aches, headache the night of the vaccine and fatigue the next 1-2 days and also huge bruise near injection site and easy bruising for 1-2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and 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 events fever, chills, night sweats, body aches, headache the night of the vaccine, fatigue the next 1-2 days and huge bruise near injection site/easy bruising for 1-2 weeks was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
He got the RSV together with Flu shot; Inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room; Numbness; Pain; had to crawl from room to room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Aug2023 as single (Batch/Lot number: unknown) at the age of 63 years for immunisation; for immunisation; influenza vaccine (INFLUENZA VACCINE), on 31Aug2023 as dose number unknown,single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (hospitalization), outcome "unknown", described as "He got the RSV together with Flu shot; Inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room"; HYPOAESTHESIA (hospitalization), outcome "unknown", described as "Numbness"; PAIN (hospitalization), outcome "unknown"; GAIT DISTURBANCE (hospitalization), outcome "unknown", described as "had to crawl from room to room". The events "he got the rsv together with flu shot; inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room", "numbness", "pain" and "had to crawl from room to room" required emergency room visit. The patient underwent the following laboratory tests and procedures: X-ray: Unknown Results, notes: they also did a spinal x-ray and nothing really showed up. Therapeutic measures were taken as a result of inflammation, hypoaesthesia, pain, gait disturbance.  Clinical course details:  He got the RSV together with Flu shot and caller mentioned that he has been in and out of the hospital, inflamed the right side of his body and he needs to crawl as he mentioned just to get out of his room. The patient ended up with inflammation in the lower back and down the leg all the way to the foot and have got numbness, had too much pain, had to crawl from room to room and leads to the emergency room to make sure I did not have a blood clot, they also did a spinal x-ray and nothing really showed up much there but I have been on physical therapy for 3 weeks so this happened before holiday so it was the months last Thursday when he got the vaccines and so just been in incredible pain. The doctor put him on Steroids and different meds (Intent: Treatment) to try to relief the pain.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
9 days post vaccination experiencing red arm, hot shot location, sore to the touch, and some itching feeling. Currently the symptoms are still occuring.
Left eye- progressive redness in sclera starting on 3/9/2021- one day after the vaccine. Progressively worsened over the week- Was diagnosed with episcleritits on Monday 3/15/21. Has not improved with topical tobradex eye drops or topical moxifloxacin eye drops.
After the FLUARIX vaccine about 10 min. later started feeling weak, drowsy & sleepy - muscles felt weak, tired. Had about 5 min. of shortness of breath. The weakness, fatigue & drowsiness lasted about 2 1/2 hrs.
Moderna vaccine administered to unauthorized age group; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to unauthorized age group) in a 12-year-old male patient 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 24-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to unauthorized age group).   At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to unauthorized age group) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Most recent FOLLOW-UP information incorporated above includes:  On 25-May-2021: nonsignificant follow up
Developed rash on both arms and legs on car on way home from receiving vaccine in our office. Returned to office for evaluation. No facial swelling, cough,wheeze or vomiting. Given Benadryl in office.
This case was reported by a other health professional and described the occurrence of expired vaccine used in a 14-year-old male patient who received ENGERIX B (batch number AHBVCO48BB, expiry date 8th September 2014). On an unknown date, the patient received ENGERIX B (unknown). On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to ENGERIX B.
Pt experienced excessive bleeding and felt "lump" at the anatomical site of the injection. Bleeding stopped upon arrival at med ops, no anxiety and pt VS presented normally.
3 days after 2nd Moderna vaccine  developed fevers, chest pain, shortness of breath. Now found to have probable constrictive pericarditis without clear etiology.
Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (659406/0298X) ZOSTAVAX on 23-MAY-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Sep2021 12:15 (Lot number: FC3184) at the age of 51 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if Covid-19 prior vaccination: Yes. Concomitant medication(s) included: Atorvastatin. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: FC3181, Administration time=12:45 PM, vaccine location=Right arm, Dose number:1), administration date: 29Aug2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: PARAESTHESIA (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Tingling in hands and feet"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Temperature"; CHILLS (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "chills"; NAUSEA (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "vomiting"; PAIN (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Body aches"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Sep2021 22:00, outcome "not recovered" and all described as "Injection site redness and pain"; HEADACHE (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Tiredness"; MYALGIA (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Joint pain"; MALAISE (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Feeling unwell"; PAIN IN EXTREMITY (non-serious) with onset 19Sep2021 22:00, outcome "not recovered", described as "Right arm pain". Therapeutic measures were not taken as a result of paraesthesia, body temperature abnormal, chills, nausea, vomiting, pain, vaccination site erythema, vaccination site pain, headache, fatigue, myalgia, arthralgia, malaise, pain in extremity. No follow-up attempts are possible. No further information is expected.
Patient developed welt type rash all over body and felt he had hard time breathing. Reaction started hours after vaccine. Came to pharmacy 6 days later. I spoke with his caregiver. Patient reported breathing ok now + rash slowly resolving.
Information has been received from a physician concerning a 25 year old male with no known allergies or psychiatric history and a history of varicella who on 02-NOV-2001, at 11:00 AM, was vaccinated with a dose of MMR (second generation). Concomitant therapy included Recombivax HB. There was no other concomitant medication. It was noted that the pt was seen later that day in the early evening, at 6:00 PM, then disappeared. On 19-NOV-2001 the pt's dead body was recovered in the river. It was reported that it was an assumed suicide. The physician reported that she only saw the client for immunizations. Unspecified medical attention was sought. Additional information has been requested. Follow-up info from the reporter indicated that "in her mind there is no connection between the vaccination and the death." Additional info has been requested.
Patient reported that the day after vaccination he developed feeling of bilateral internal ear swelling, pressure and discomfort.
pt recv vax 12AUG98 & 14AUG98 pt devel itchy rash on cheeks, fingers & interdigitally;nurse described the rash as being urticarial & vesicular in nature;MD visit was required;
Patient passed out and hit her head on the back of a chair.  Recovered after a few seconds and awoke laughing.  Gave crackers and fluids po.  Patient states she felt fine after just a few minutes.
Patient received vaccination, no issues at time,  came back to pharmacy on 10/24/22 reporting a rash that began the evening of the vaccination.  she said she was itching and could not get any relief so finally decided to come to pharmacy. Her face was red and a visible reaction could be seen.  she was given Claritin to help with the itching and told to report to doctor if no relief.  Pharmacist called her a couple of days later and she reported going to doctor and receiving a steroid shot  she said the itching was still present but it was getting better
37-year-old female who presents to the emergency room with what appears to be an anaphylactic reaction after receiving the Pfizer COVID vaccine.  Shortly after receiving the vaccine, patient reported dizziness, tongue swelling and sensation of throat closing.  There was no true syncope.  The patient was given IM epinephrine.  She reports improvement of some of her symptoms.  The patient was monitored here for about 3 hr after her epi dose.  She received prednisone and Benadryl with improvement of symptoms.  Her airway remains patent and open, without any respiratory distress.  She is stable for discharge home
Significant (extensive) erythema and edema at injection site on right thigh, covering the middle third anterolateral and medial aspects. The reaction was immediate (within 5 minutes).
feeling weak; dizziness; diarrhea; heart rate raising; site of injection tiny warm; feeling sick since friday; Redness; fever; chills; fatigue; light headache; nausea; This spontaneous report was received from consumer on 25-JAN-2021, concerning a 58 year old female patient who was administered Moderna COVID-19 vaccine9( mRNA-1273). The patient experienced redness, fever, chills, fatigue, diarrhea, headache, nausea, dizziness, heart rate raising, feeling sick, weak , site of injection tiny warm  The patient's medical history was provided she has asthma and Concomitant  medication was  albuterol hfa, spironolactone, losartan,   Carvedilol, benzonatate , fluoxetine           The patient received suspect product  mRNA-1273 on 21/Jan/2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:unknown) expiry  intramuscularly on the left arm for prophylaxis of COVID-19 infection  the patient received the first shot of the Moderna vaccine. She has done the antibody test and the results are that she has antibodies against COVID-19. Action taken with the second dose of mRNA-1273  in response to the event was not reported
Shot was given high on arm close to bone. Immediate pain as the fluid was injected.  Very uncomfortable pain from shoulder to elbow for next three days. I am still experiencing mild pain in the area of the injection. I took aspirin and 1/2 325 Vicodin (generic brand hydro) that I have for chronic back pain. I thought I was recovering fully but still have mild pain at injection sight. I contacted my doctor  and was told to take Tylenol and advise if discomfort continued.  My shot was given about 4PM at station #5. I have investigated online and I believe that I have SIRVA (When an intramuscular  deltoid injection is administered into the shoulder joint) symptoms.  I am having difficulty understanding how a nurse could have made that mistake and think it should be investigated. I might also note that I am retired military and was wearing a veteran hat at that time??? I am hoping this will clear up but am concerned about that nurse(?)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: Em9810), in left arm, on 12Mar2021 as dose 2, single (Lot number: En6208), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: Ew0196), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: Fk9729) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "slight thyroid issue" (unspecified if ongoing); "known allergies:Quinolones" (unspecified if ongoing). Concomitant medication(s) included: LIVALO, start date: 01Jan2018, stop date: 22Sep2022; LOSARTAN, stop date: 22Sep2022; LEVOTHYROXINE, stop date: 22Sep2022; EZETIMIBE, stop date: 22Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Positive, notes: Diagnosed 21Sep; Body temperature: (Sep2022) I had 101-102 fever each afternoon for about 3-4, notes: days. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 22Sep2022 to 26Sep2022. Clinical course: Adverse event was diagnosed on 21Sep. First bout, I had 101-102 fever each afternoon for about 3-4 days, and night sweats, fatigue. The patient received any other medication in two weeks.
Dr. call the pharmacy to report that the patient has been experiencing headache, nausea, leg pain and chest pain since receiving the janssen shot.
-Had fever, extreme fatigue + body aches following second dose -Now has lymphocytosis - count 47% and neutropenia - count 41% > 11/04/2021
Fever 100.8, right arm soreness and fatigue. Treatment: Tylenol. Outcome: mild improvement
MY BODY FEELS INFLAMED. I AM ITCHING ALL OVER, MY COLOR HAS CHANGED FROM PALE TO SOME REDNESS.  BENADRYL AND PEPCID NO LONGER SEEM TO BE WORKING. I DO NOT HAVE HIVES, JUST A LOT OF ITCHINESS. THIS BEGAN ON THURSDAY AFTERNOON, AND IS STILL GOING AND TODAY IS TUESDAY.
Muscle twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle twitching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle twitching). At the time of the report, MUSCLE TWITCHING (Muscle twitching) outcome was unknown.            Patient experienced muscle twitching a week after second shot. No concomitant and treatment medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Patient was diagnosed with COVID infection on 6/1/2021 and was hospitalized with COVID pneumonia
Rc'd apx 12noon  on 2nd, following am 2/3 expected sore arm, but shoulder also painful which progressed and  more intense , left side neck pain , between shoulders, and left shoulder. appx   2/6 pain more intense, weakness unable to raise arm fully saw Dr. 2/11  which he dx as Roto Cuff injury, and injected shoulder. 3 days later pain started to lessen. Pain now  with certain movements but still unabe to raise arm fully
DVTs in both legs; Femoral artery clotted from my thigh to my ankle; This is a spontaneous report from a Pfizer-sponsored program, PFIZER RXPATHWAYS. A contactable consumer (patient) reported that a male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included apixaban (ELIQUIS). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient had deep vein thrombosis (DVTs) in both legs; and femoral artery had clotted from the thigh to the ankle. The events were assessed as serious (medically significant). The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # L006384, expiration date 25-FEB-2017 (dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
I slowly started getting body aches about 5 hours after the shot. About 12 hours after body aches were terrible and a fever started. The next morning, body aches and fever have somewhat subsided compared to last night, but now I have level 7 pain in my left armpit and nausea.
My RSV symptoms started on 12/29/2022 late afternoon I was experiencing difficulty breathing.  I used my rescue inhaler ( Nebulizer) and Albuterol which my doctor prescribed previously for Bronchitis.  On 12/29/2022 I went to the ER 6:00am . They did RSV, CAT-Scan and X-RAY. I was positive for RSV. At the ER they gave me breathing treatments. I used it occasionally as per needed. On 12/30/2022 I was experiencing difficulty breathing again  and my o2 level was low so I was taken to the hospital. They  gave me breathing treatments and IV. I was in the for 5 nights and 6 days. I was released from the hospital on 01/04/20223.