chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case PHEH2016US022002, is an initial spontaneous case received from a physician on 25 Aug 2016. This report refers to an 80 years old male patient. Medical history and concomitant medications was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this administration error (expired product administered).
headache; tired; general feeling unwell; This Initial case was previously missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 18Oct2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She also had covid before any of the Pfizer shots", start date: 06Jan2021 (unspecified if ongoing), notes: Illness/AE: Covid-19, Onset date: 06Jan2021, pertinent details: 4 days in hospital breathing issues-on oxygen for 3 mo.; "Polymyalgia", start date: Jun2023 (ongoing), notes: Patient's Medical history:, Illness/AE: Polymyalgia, Onset date: early Jun2023, Stop date: Ongoing.; "I have had palpitations since pre-teen" (unspecified if ongoing), notes: I have had palpitations since pre-teen; "osteoporosis" (unspecified if ongoing); "Polymyalgia Rheumatica" (unspecified if ongoing); "thyroid (low)" (unspecified if ongoing); "cholesterol (A.gh)" (unspecified if ongoing); "Protect stomachache from prednisone" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE SODIUM oral taken for osteoporosis (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing); PRAVASTATIN oral taken for blood cholesterol abnormal (ongoing); OMEPRAZOLE taken for abdominal pain upper (ongoing); PREDNISONE taken for polymyalgia rheumatica (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, First dose of Pfizer covid vaccine: 15Apr2021, Lot: EW0164), administration date: 15Apr2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "headache", "tired", "general feeling unwell"; bnt162b2 (DOSE 2, SINGLE, Second dose of Pfizer covid vaccine: 06May2021, Lot: EW0172, Time: 8 AM, Anatomical site of injection: Left arm, Route of Administration: Intramuscular), administration date: 06May2021, when the patient was 73-year-old, for COVID-19 Immunization, reaction(s): "headache", "tired", "general feeling unwell". The following information was reported: HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "tired"; MALAISE (non-serious), outcome "unknown", described as "general feeling unwell". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321140 Same patient, different vaccine dose and event;
Started with headache, full body aches, then chills, nausea, loss of appetite, then 101.1°F fever (after taking 300mg Tylenol). Generally fatigue, depressed mood & irritation
I had sinus congestion, headache, and sore throat. I tested positive for COVID-19 at home on 10/25/2022. I called my doctor on the same day and he prescribed me Paxlovid. The symptoms mostly went away 10/27/2022.
Swollen arm; Red; Hot; Not unbearable, but uncomfortable; Sore; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red), FEELING HOT (Hot), FEELING ABNORMAL (Not unbearable, but uncomfortable) and MYALGIA (Sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were provided by reporter.  Concomitant products included THYROID and DENOSUMAB (PROLIA) for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red), FEELING HOT (Hot), FEELING ABNORMAL (Not unbearable, but uncomfortable) and MYALGIA (Sore). On 14-Sep-2021, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red), FEELING HOT (Hot), FEELING ABNORMAL (Not unbearable, but uncomfortable) and MYALGIA (Sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also include also for blood pressure. (unspecified drug name). Patient stated that no treatment for the adverse events.
This patient was admitted to the Hospital on 1/9/2022 for COVID pneumonia. This is considered a breakthrough case.
The evening after shots, pt had aching muscles. He continues to have arm pain, usually at night. He states has some decreased ROM when he's having pain and a decrease in arm strength. He has continued complaint.
Sinus Congestion, Sore Throat, Coughing, Hoarseness - Continued symptoms as of today 10/5/2014.
This spontaneous report was received from a healthcare worker concerning multiple patients of unknown demographics. On unknown dates, multiple different unspecified patients received a dose of PROQUAD (Merck) (unspecified lot # and expiry date) that was improperly stored. No adverse effects reported, No product quality complaint was involved. The case is also relate to 1506USA002056, 1507USA010860 and 1507USA010861 (same reporter link). Additional information has been requested,
aches and pains; some diarrhea; Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful; Huge bubble on the same side of my shot right above the clavicle/it's getting smaller; fever; severe headache; some nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06G20A, 029A21A and P57F27A) 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 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller), PYREXIA (fever), HEADACHE (severe headache) and NAUSEA (some nausea). At the time of the report, PAIN (aches and pains), DIARRHOEA (some diarrhea), LYMPHADENOPATHY (Ipsilateral Supraclavicular Adenopathy/swollen lymph nodes in the armpit/which were very painful), PYREXIA (fever), HEADACHE (severe headache) and NAUSEA (some nausea) outcome was unknown and VACCINATION SITE SWELLING (Huge bubble on the same side of my shot right above the clavicle/it's getting smaller) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow-up received on 29-Nov-2021 and contains significant information updated reporter details, patient demographics, vaccine details and events updated. On 30-Nov-2021: Follow-up information received was contain no new information.
Narrative:  employee saw MD who treated rash and advised against second dose. Rash was all over body.
pt recvd vax & exp h/a, joint aches, sore throat, rash that began on stomach to face & t101, lt shoulder pain (lt shoulder inject site), fingers knuckles swollen, reddish welts/hive, raised, blotchy, fatigued;
Patient came over to clinic to receive vaccination of HPV and Menactra.  Patient was given menecta injection in right deltoid and also given HPV in left deltoid in medication room.  She walked out to hallway in clinic to get a stuffed animal and patient c/o being dizzy per Dr. Dr. assisted her to a chair in the clinic.  Patient was mildly diaphoretic.  Nurse took her VS and she then said, she felt like she was going to throw up.  She closed her eyes briefly.  Nurse Gave her a few sternal rubs.  She responded  to the sternal rubs, she c/o being thirsting.  Epinephrine pen was given per Dr. Patient was able to answers question appropriately then she stated she felt better.   VS: pulse ox 96% to RA, pulse 84, temp 97.5, b/p 97/64. Staff called 911.  When ambulance arrived she was able to answer questions by emergency personnel.  Patient transported to ER per ambulance.  Patient returned from ER around 5:00 pm the same day.  Therapist checked in with patient.  She was monitored through out night and legal guardian was notified.
At roughly 8 to 10 hours after injection I started developing a minor fever, fatigue, slight loss of appetite, lack of focus, chills and aches. Signs and symptoms continued to worsen throughout the night and next morning. Unable to sleep due to an increase in chills, fever progressed to 101.3F, developed a severe headache, aches were more prominent, same with fatigue. Loss of appetite went away. Started taking cold medication in the morning which either helped reduce the signs and symptoms or I had already experienced the apex of the adverse events. Fever was reduced, same with the aches and chills. Everything is fairly minor now, but the severe headache continued to to be present untill a second round of cold medication. Still fatigued when writing this at 9:30pm at night despite sleeping the majority of the day.
Shaking; This spontaneous case, initially received from a pharmacist on 07-Nov-2018, concerns a 60-year-old, adult, female patient.  On 06-Nov-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39007 and expiry date: 30-Jun-2019] for influenza prophylaxis.  On the same day, three hours after vaccination, the patient experienced shaking.  At the time of the report, the outcome of the event was not reported.   This reporter considered the case as non-serious.; Reporter's Comments: A 60-year-old, female patient experienced shaking, three hours after vaccination with Afluria Quadrivalent. The company assessed the causality as related considering the plausible temporal relationship between the event and suspect vaccine.
Initial report received from a healthcare professional on 17 October 2012. A 31-year-old pregnant female patient had received an intramuscular dose 1 of ADACEL (lot number U4421AA, site of administration was not reported) on 17 October 2012. The patient's last menstrual period date was 15 March 2012. The estimated date of delivery was 20 December 2012. At the time of the report, the patient had not experienced any adverse events. The patient's health during pregnancy, risk factors was reported as not applicable. Concomitant medications and past medical history was not reported. Follow-up information was received 03 September 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been updated to serious. The pregnant female received an injection of RHOGAM (other manufacturer, lot number, site, side, and route of administration not reported). Relevant illness during pregnancy/ongoing was reported as chronic hypertension (CHTN) and intrauterine growth restriction (IUGR). The patient had two previous pregnancies with normal outcomes. The last menstrual period was 15 March 2012. On 05 December 2012, the patient delivered a normal infant. The patient's outcome for the events of CHTN and IUGR was not reported. Documents held by sender: None.
After receiving Moderna booster Client walked a few distance and collapsed into a chair. She was alert and response but feeling dizzy and weak. Patient responded to Ammonia Inhalant. BP was taken three times: 98/60, 100/50, 100/60. Patient was alert but still felt weak and was given orange juice.  Patient stated that she had a history of low blood pressure was nervous.  Client stated a history of spontaneous panic attacks and was feeling nervous.  Client waited in observation for 30 minutes. Client was able to walk to vehicle with family members.
Red rash on left arm approximately 3 inches circumference about 2 to3 inches distal to the injection site. Patient is placing ice on the rash. Patient states the rash is slowly going away
broke out in rash morning of 27NOV96, seen in office w/dx of chicken pox & zovirax was prescribed;
Narrative:  57 y/o male with PMH for diabetes, hypothyroidism, hypertension, BPH, hyperlipidemia, and asthma. Pt presented to ED with complaints of fever, cough, chills and fatigue on 5/21/22. Pt admitted to hospital with COVID 19, chest pain and asthma exacerbation. Pt treated w/ remdesivir (05/21-05/23), dexamethasone (05/22, 05/23) and azithromycin (05/21, 05/22). Pt improved and discharged to home on 05/23.
1/11/2021- 0900AM-0830PM: Sore Arm 1/11/2021_ 8:30PM through 1/13/2021 8:30PM: sore arm,103-104 fever, chills that manifested in full body shakes (uncontrollable) and while extremities followed by increase fever and sweats (3x's). Brest/ Chest pain (left side) Went to Medical Center and with out taking vitals patient was told there was nothing they could do and patient was sent home.
Moderate to severe dizziness; Severe fatigue; Pyrexia; Moderate Pain at IP Site; Mild headache; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications taken within two weeks prior to the vaccination were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in left arm on 18Mar2021, at 13:45 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 15:30, the patient experienced moderate to severe dizziness, severe fatigue, pyrexia, moderate pain at IP site (coded to vaccination site pain) and mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events moderate to severe dizziness, severe fatigue, pyrexia moderate pain at IP site (coded to vaccination site pain) and mild headache was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Swelling and redness near injection site that migrated toward elbow. Pt was seen at a urgent care diagnosed w/possible cellulitis and given doxycycline oral antibiotic.
hard lump followed by rash which expanded to a 3 inch wide area ultimately almost reaching bend of arm at elbow.
p/immun given 3FEB93, pt later that day became lethargic & virtually unresponsive; parents reported this 12APR93;
At first normal symptoms, fever, chills, soreness in booster shot area starting after 12 hours after booster. Those symptoms were gone after 36 hours of starting. However, constant headache and fatigue continue.
Pt. reported swelling of left eye et "hard breathing" after receiving TDAP vaccine. Pt. self-administered ephedrine, BENADRYL et asthma inhalers as reported by self et reported reduction of swelling thereafter. Did not seek medical attention et reported to "be fine".
Patient described crackle noises heard from lungs audible with out stethoscope starting at bedtime 9/22/18. Patient also listened to heart with stethoscope and heard an irregular beat, more than what she normally has. Patient described that symptoms disappeared when she woke up in the morning, only describing tiredness and breathlessness on exertion more than usual. Bedtime 9/23/2018 symptoms returned but in a less intense fashion. 9/24/2018 at bedtime symptoms were gone except for the continued tiredness and breathlessness upon exertion. 9/25/2018 patient will follow up with MD in afternoon time.
pt & mom returned to clinic 1/2 hr p/receiving vax w/red rash on legs extending from ankles to hip line; pt c/o all over itching including scalp; referred to local MD; PDH ordered w/relief obtained;
Was given the incorrect vaccination.  Went to get a booster vaccine and was given this by pharmacist. No possible side effects as of now.
Severe swelling at injection site; fever; nausea; vomiting; migraine; fatigue; swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 15:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), autism spectrum disorder, attention deficit hyperactivity disorder (ADHD) and allergies to penicillin and latex. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), sertraline hydrochloride (ZOLOFT), clonidine (MANUFACTURER UNKNOWN) and ethinylestradiol, norethisterone (NECON 35); all from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 23-year-old) as a single dose for COVID-19 immunization, previously received Sulfur on unknown date and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, at 00:00 the patient experienced Severe swelling at injection site, fever, nausea, vomiting, migraine, fatigue and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event Severe swelling at injection site, fever, nausea, vomiting, migraine, fatigue and swollen lymph nodes was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter information (MD captured as suffix), Patient Email address updated, Concomitant medication (ADDERALL updated to ADDERALL XR, NECON updated to NECON 35), updated narrative ("ADHD" updated to "attention deficit hyperactivity disorder (ADHD)", "as a single dose for COVID-19 immunisation and Sulfur on unknown date and experienced allergy" updated to "as a single dose for COVID-19 immunisation, previously received Sulfur on unknown date and experienced allergy").
pt recv vax 26NOV96 & 1OCT97 pt exp a breakthrough case of chickenpox w/unk number of vesicles & a temp 99.4;pt examined by health care provider;
The evening of Sept. 8 my sone started to get tow welts on the arm the injections were done, arm was sore and warm to the touch. We have allergy medication and when he woke the morning of Sept 10 almost his entire upper arm was one large welt, red, warm to the touch and he was also running a low grade fever of 100.8. He was complains of pain in his arm and later in the arm it had gone to his shoulder area.
ATRIAL FIBRILLATION, SHALLOW BREATHING, FEVER, EXCESS URINATION.
This is a spontaneous report from a contactable consumer. A 69-year-old female patient of unspecified ethnicity received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (TRADE NAME UNSPECIFIED; Lot number unknown), via an unspecified route of administration, in 2005, as single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia. The clinical course was reported as follows: a 69-year old patient received a "pneumonia shot" (brand name unknown) in 2005; then the patient got pneumonia on an unspecified date. The outcome of pneumonia was unknown. Pfizer is a marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 01-FEB-2016, the patient was vaccinated with an expiry dose of ZOSTAVAX (lot # K014834, exp. 14-DEC-2015, subcutaneous, dose not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Hives (welts) on bilat arms and chin-gave Benadryl and hives disappeard by the next morning.