chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; Chills; Aches were pronounced on chest and neck, up into jaw; Aches were pronounced on chest and neck, up into jaw; Aches were pronounced on chest and neck, up into jaw; Extremely uncomfortable; Feeling muscle aches, especially around chest; Extremely tired; Like getting sick tired; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 30Aug2021 at 09:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included triamcinolone acetonide (NASACORT) and fexofenadine hydrochloride (ALLEGRA); both for an unknown indications from an unknown dates and unknown if ongoing. On 30Aug2021 (first day), the patient was extremely tired, like getting sick tired. On 31Aug2021 (second day), the patient felt great. On 01Sep2021 (third day) at 14:00, the patient started feeling muscle aches, especially around chest. On 02Sep2021 (fourth day), the aches were pronounced on chest and neck, up into the jaw, to the point that the patient was extremely uncomfortable. On 03Sep2021 (fifth day), the patient had a migraine, along with muscle aches. The patient had no fever but had chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events extremely tired and like getting sick tired were resolving while that of events feeling muscle aches, especially around chest, aches were pronounced chest and neck, up into jaw, extremely uncomfortable, migraine and chills were not recovered at the time of this report.
Information has been received from a registered nurse concerning an 18 year old female patient with no medical history or allergies reported, who on 12-MAY-2008 was vaccinated intramuscularly with the first dose 0.5 ml dose of GARDASIL (Lot #655604/0052X). Concomitant therapy included oral contraceptives (unspecified). On 12-MAY-2008, "within a few minutes of receiving her first dose," the patient became lightheaded, pale, developed a cold sweat and nausea. No diagnostic laboratory testing was performed. On 12-MAY-2008 the patient recovered while in the office. No product quality complaint was involved. The reporter considered lightheadedness, pale, cold sweat and nausea to be disabling for a short time while the patient was in the office. Additional information has been requested.
Headache; pain in her arm at the injection site; Quivering in chest; Sleepy; Lightheadedness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports.  A female patient of an unspecified age received BNT162B2 (Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, pain in her arm at the injection site, quivering in chest and sleepy on an unspecified date. On 23Jan2021, the patient experienced lightheadedness. Lightheadedness was reported as worsened. The outcome of the event "lightheadedness" was not recovered. The outcome of the other events was unknown.  Information about Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117202 same reporter/drug, similar events, different patient
Pt fainted in her chair, fell to her knees and slid her head along the floor causing two abrasions to the right side of her face. Pt states she has a history of fainting after getting blood drawn. Pt denies any head or neck pain. Pt denies any dizziness or blurry vision. Pts pupils are equal and reactive. Pt is moved to the exam room and seated on a cot. Pts vitals are stable. Pt states she is feeling better after laying down for 20 minutes. EMS advised that she should go to the hospital for an evaluation. Pt refused transport to hospital. Pt was walked out to her car/ Pts husband drove her home.
Hyperirritable & appeared "dazed" in the 48 hrs following DTP;
Patient developed low grade fever, mild dry cough, mild sore throat, arthralgia.  Symptoms started day after receiving vaccine.  Symptoms resolved over 4-5 days, mild cough has continued.
Patient reported to the Emergency Department approximately three hours after receiving smallpox vaccine. The patient had a red rash to the entire body. Patient did not have throat swelling, but did complain of funny feeling in his chest. Patient was discharged from the Emergency Department with cetirizine and dexamethasone.
got sick after each one of her covid vaccines; body aches; not feeling well; dose1 12-OCT-2021/ dose-2  27-OCT-2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick after each one of her covid vaccines), PAIN (body aches), MALAISE (not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose1 12-OCT-2021/ dose-2  27-OCT-2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    Previously administered products included for Fibromyalgia: Cymbalta; for Depression: Cymbalta. Past adverse reactions to the above products included No adverse event with Cymbalta and Cymbalta. Concurrent medical conditions included Ulcerative colitis and Crohn's disease.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose1 12-OCT-2021/ dose-2  27-OCT-2021). On an unknown date, the patient experienced ILLNESS (got sick after each one of her covid vaccines), PAIN (body aches) and MALAISE (not feeling well). At the time of the report, ILLNESS (got sick after each one of her covid vaccines) was resolving and PAIN (body aches), MALAISE (not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dose1 12-OCT-2021/ dose-2  27-OCT-2021) outcome was unknown.            The patient got sick after each one of her covid vaccines also had body aches and she was not feeling well.   No Concomitant medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623271, MOD-2022-624654 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2022: Significant live follow-up appended-Update in medical history received
soreness at sight of injection; fatigue; shoulder stiffness; breastfed 7-month-old daughter has not been herself since/had poor sleeping, fussiness, and feeds less/has been 3 nights in a row of abnormal behavior; breastfed 7-month-old daughter has not been herself since/had poor sleeping, fussiness, and feeds less/has been 3 nights in a row of abnormal behavior; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 14Mar2021 at 12:30 (at 31 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE ALLERGY RELIEF); all from unspecified date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 14Mar2021 at 18:00, the patient experienced soreness at sight of injection, fatigue, and shoulder stiffness. It was also reported that the personal side effects were mild. However, her breastfed 7-month-old daughter, experienced poor sleeping, fussiness, and feeds less which continued for 3 nights in a row of abnormal behavior for her. The patient did not receive treatment for the events. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021305422 infant case
100.0 F TEMP X 1 DAY AFTER. SEVERE REDNESS/PAIN/HIVES 6 IN BELOW INJECTION SITE THAT LASTED 1-3 DAYS.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 31-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # L016284 with an expiration date on 07-AUG-2016; dose and route of administration were not provided). There was no adverse effect reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient had no symptoms at administration patient came back to pharmacy with prescriptions for reaction 5 days later.
On 3/18/10 at 11:00 AM a call was placed by client to a nurse supervisor stating that last evening client was with her spouse and he described her having a seizure for one minute.
Patient had her first dose of Moderna vaccine admistered at approximately 1315 on 3/4/2021. She waited the 15 minutes as recommended and had no symptoms or concerns. She left our suite and stopped off at the restroom before she left for work and noticed that her face and nose was reddened when she took off her facial mask. She returned to our site at approximately 1340/1345 and was brought back to an exam room. At this time she complained of slight lip tingling. Dr. was asked to assess patient. No difficulty swallowing or breathing, HR 82, pulse ox 99%. No facial swelling. Glass of water offered and patient finished without any concerns. Dr. ordered 25 mg of Benadryl (patient was going to work ). She was monitored until 1430 and then  discharged at approximately 1440. No localized reaction at injection site noticed. Patient went to work and was fine until the Benadryl wore off-she did take an addtional 25 mg of Bendadryl. Upon awaking the next day 3/5/2021, her facial area was swollen and slightly reddened. She was instructed to call her PCP. Patient continued to take Bendadryl, and by Sunday 3/7/2021 she was back to baseline.
HEADACHE, STIFF NECK, CHILLS OF SHORT DURATION, LEADING TO IMBALANCE, FINE TREMORS,  SEVERE "HEAD FOG", DYSPHAGIA,
Fevers ranging from 100.1-104.7, severe chills, body aches, headaches, and fatigue for several days.  Still not feeling 100%.
nausea, chills ,temp of 101.3, exhaustion,  upper breast lymph nodes painful , loss of taste & smell  - occurred over 1 week time frame
swollen lymph node in left arm pit, pain at vaccination site similar to original pain right after vaccination for first 2 days, then on 1/18 developed itchy hives on left arm around site of vaccination, hives are raised - lymph node swelling has been for about 5 days now and hives for 2 days
Possible fatigue, headache, body aches and fever.  Will discuss with pt when he or his wife return my phone call
Rush of tingling sensation and lightheadness. Symptoms resolved 10 mins later per pt
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 11/6/2022  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient complained that the intern that gave her the shot gave the shot too high and the patient's arm shortly after became very painful and she could not move her arm even a few days after the shot.  The husband states that she is in more pain that her previous root canals. She thinks the intern went too high in the arm and hit a nerve.
Within 24 hours, a large red spot at injection site measuring 2" x 2" was hard, swollen and sore.  By 48 hours post-injection, the red spot is now 3"x 3" still hard, red, swollen, sore and itchy.
The patient had J&J vaccine in April 2021. She had outpatient COVID-19 disease in mid-Sept 2021. She received monoclonal antibody at that time (casirivimab/imdevimab). She was still having fatigue, malaise post-COVID-19 when I saw her on Nov 30, 2021. At that time, she had already had a booster with Moderna on Nov 26, 2021 at the Pharmacy. I am not sure if they did proper screening because she had monoclonal antibody less than three months before on Sept 17, 2021. Anyway, in December, she developed rapid and severe dementia. For example, even now she doesn't remember that Christmas even happened. She got up in the middle of the night last night to go get a blood draw and was confused. She can't remember the date. She has no short term memory. She can no longer run her husband's appliance repair business as she was (scheduling, taking calls, doing tasks related to the running of the business).
injection site pain; This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported, however it could be over 50 years. The reporter stated that the patient had pain at injection site after vaccination. The patient refused second dose due to the adverse event. This case has been linked to US2019AMR222635, reported by the same reporter.
tingling sensation on left hand going up to left forearm; numbness on the left hand going up to her left forearm.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling sensation on left hand going up to left forearm) and HYPOAESTHESIA (numbness on the left hand going up to her left forearm.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced PARAESTHESIA (tingling sensation on left hand going up to left forearm) and HYPOAESTHESIA (numbness on the left hand going up to her left forearm.). At the time of the report, PARAESTHESIA (tingling sensation on left hand going up to left forearm) and HYPOAESTHESIA (numbness on the left hand going up to her left forearm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Monovalent pfizer was given instead of bivalent pfizer. Will notify patient and offer bivalent in two months PCP has reviewed the chart
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years old patient who received a dose of vaccine MENACTRA lot number not reported via unknown route in unknown administration site on 20-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was also the case of off label use. It was reported that 64 patient year old patient received MENACTRA on 20Oct2018 and was instructed by her doctor to get another vaccination 8 weeks later. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Received Prevnar shot at approx. 2pm. Night 1: fever of 100.9 for 24 hours. Nights 2-3: formerly sound sleeper was very restless; woke up every hour crying inconsolably as if she was in pain. Post-vaccine day 3: developed a respiratory issue with a severely stuffy/runny nose and cough; symptoms lasted two weeks. Since the vaccine: my formerly happy baby is very fussy and irritable; hard to console, cries randomly. She was also saying "name" and "dada" before the vaccine but we haven't heard her articulate those words since.
injection arm was not really sore like after the 1st dose; Shaking chills for a couple of hours or so; Really tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (injection arm was not really sore like after the 1st dose), CHILLS (Shaking chills for a couple of hours or so) and FATIGUE (Really tired for a day) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (Shaking chills for a couple of hours or so) and FATIGUE (Really tired for a day). On an unknown date, the patient experienced PAIN IN EXTREMITY (injection arm was not really sore like after the 1st dose). On 09-Mar-2021, CHILLS (Shaking chills for a couple of hours or so) had resolved. On 10-Mar-2021, FATIGUE (Really tired for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (injection arm was not really sore like after the 1st dose) had resolved.            Treatment information was not reported.  No concomitant medication was reported by the reporter.   This case was linked to MOD-2021-028994 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Event outcome updated.
This spontaneous report as received from a health professional (office manager) refers to approximately 78 year male old patient with no drug reactions and allergies. Pertinent medical history was none. On 18-MAR-2013, the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (lot # H014196,expiry date 19-MAR-2014, dose was not reported) intradermally in the forearm. Concomitant medications were none. Approximately on 18-MAR-2013, following vaccination, the patient experienced bacterial infection at the injection site. On 20-MAR-2013, the patient visited the physicians office to get the results of the TB (Tuberculosis). The patient presented with a pretty bas infection at the injection site of his forearm. The patient was placed on unspecified antibiotics due to the infection. Laboratory test performed was none.The event infection was not recovered at the time of this report. The reporter requested for the lot check since the 2 patients had received from the same lot. This is one of the reports received from the same reporter. Additional information has been requested.
I went home and at about 7 pm I went twice to the bathroom, before 9 pm. I started feeling very sick. I was okay until Thursday. On Friday I could not get up to go to work. I was feeling feverish, achy, I had chills. I could not even get up to get something to eat. I do not feel like myself. I sent a text to my doctor on Thursday at 11:05 PM. He called me back at 11:33AM and I told him about my symptoms. He said that I should feel better in a couple of days. He said I should take Ibuprofen, which he sent to the pharmacy. I continued to go to work, except for today because I still have diarrhea. I am not my normal self. I was ok until Thursday before taking the vaccine. I do not feel right. I am not a person who gets sick. I am not taking any other vaccines.
PFIZER ORANGE (5-11YRS) BIVALENT VACCINE GIVEN AS FIRST DOSE OF PRIMARY SERIES
Redness, pain, hives (within 24h) (Treated with OTC BENADRYL) on right arm only.
Pt given pediatric dose of pfizer vaccine 0.2ml and pt is 12yrs 1 month old.    Pt's mother was informed just after the vaccine was given that the pt received the wrong dose and that the series would have to be restarted.  Pt's mother instructed to wait 3-4 weeks before pt should receive actual dose 1
No adverse event occurred. Patient received a third dose of the covid vaccine too soon according to protcol.
Heavy cramping and bleeding - period began early and heavily. Unable to hold tampons without body cramping ( even light while I use regular, and super through period usually).   Exhausted, some back pain and discomfort from cramping. Unable to stand upright to walk due to cramping on day 2 after vaccination. Tried to rest. Stayed in bed on day three, slept 15 hrs on day four as pain was extreme. Bought and Wore heavy pads to protect.  Alternating loose stools and constipation. Full abdomen pain. Not able to leave house alone for groceries. Won?t drive.
Pain at the time of injection on receipt of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The reporter reported that, she knew several people who have complained about having pain at the time of injection on receipt of Shingrix. She said that, she could try to get more details but had no specifics about the people she referred to who complained about pain at time of call. The reporter preferred to remain anonymous (did not want profile created in database) but she agreed to follow up via email. The reporter consented to follow up.