chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports injection site reaction that is ongoing in the right arm. Patient reports that she received her first vaccination in her right and her second in her left and ever since will experience stinging sensations that come and go in the right arm.
This spontaneous report as received from a nurse refers to a 7 months 26 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
He presented to the ED on 8/11/2021 for cough, shortness of breath and fatigue. No prior COVID-19 infections.
Information has been received from a health professional concerning a 9 yr old male described as healthy with no known medical history or allergies who on 07OCT97 was vaccinated with a 0.5mL SC second dose of varicella virus vaccine live (lot623645/0696E). There was no concomitant medication. On 16Sep05 the pt developed a breakthrough case of varicella of about 20 lesions with itching. The pt's chickenpox was also described as scattered small spots, approx 25 lesions, with itching and body aches. Unspecified medical attention was sought and diphenhydramine hydrochloride (Benadryl) was prescribed for the itching. At the time of the report the pt had recovered. There was no product quality complaint involved. Additional information is not expected.
Pt recvd Engerix-B vax on 18MAR91, & on 19MAR91 exp induration, erythema, lymph node enlargement, & tenderness; Pt seen in ER; Considered to be cellulitis;
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of M-M-R II (lot # K024824 with expired date 02-DEC-2016) which were exposed to temperatures outside of the recommended range. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
2/24/21 Patient Died.  02/23/21. Patient came to ED for weakness/falls. Patient had fallen on 02/21 and 02/23. UA was done in LTC, and he was started on ciprofloxacin 02/22/21. Treatment was to put patient on comfort cares (morphine + lorazepam)
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 31-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The injection site & surrounding 3" in every direction is hot, red, hard, itchy, and sore to the touch. My cheeks also turned bright red, but that has subsided overnight.
Information has been received from a physician through a Merck Pregnancy Registry concerning a 25 year old white female with concurrent medical conditions reported as "good". She has a history of 3 pregnancies (1 live birth full term at 38 weeks and 4 days, and termination of pregnancy - elective), no birth defects in previous pregnancies, herpes genitalis, abnormal PAP with CIN II on 15-SEP-2006 and she had loop electrosurgical excision procedure (LEEP). No history of drug reactions/allergies. On 08-SEP-2006, the patient was vaccinated with the first dose of Gardasil (lot # 654540/0800F). Concomitant medication reported as none. On 03-NOV-2006, the patient was vaccinated with second dose of Gardasil (lot # 653938/0954F) 0.5 ml intramuscularly while she was pregnant. The patient did not have a reliable last menstrual period (LMP) date. The patent sought medical attention. On 05-DEC-2006, an ultrasound was performed to confirm her estimated date of delivery (EDC). The ultrasound revealed EDC of 14-JUL-2007 and single viable intrauterine pregnancy. At the time of reporting, her gestation time was 8 week (LMP 06-OCT-2006). No adverse experience is related to this event. On 23-JUL-2007, an Outcome Pregnancy Questionnaire provided additional information. There were no complications during the pregnancy or labor/delivery. A diagnostic ultrasound was performed during pregnancy, which was within normal limits (NL). The patient developed influenza B during pregnancy. During pregnancy, the patient was treated with FAMVIR for herpes (September 2006), acyclovir 400 mg, twice daily (BID) for herpes, terbutaline for pre-term contractions (dose, duration, and route not reported), and RYNEZE BID on 15-MAR-2007 for rhinitis (dose and route not reported), BIDEX DM three times daily (TID) and Z-PAC for an upper respiratory infection (dose and route not reported) on 19-FEB-2007; DIFLUCAN for vaginitis, DRETHINE and CELESTONE for pre-term contractions (dose, duration, and route not provided) on 29-MAY-2007. On 29-JUN-2007, 37 weeks and 4 days from last menstrual period (LMP), the patient delivered a normal male infant (8 lbs, 8 oz, 21 in) with an APGAR score of 8/9. There were no congential anomalies, complications, or abnormalities. Additional information has been requested.
He experienced swelling on right foot (toes & arch) a few hours after flu shot & didn't know if it was related. It felt like gout & was painful. He took some VICODIN & CELEBREX. Pain & swelling resolved next day.
Information was received from a health professional regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) lot #J003221, expiration date 15-MAR-2015, which had been improperly stored. The outcome of the improperly stored vaccination was unknown. This is a corrected report. On 23-SEP-2013, information was received from a registered nurse concerning the unknown age and gender patient. It was reported that VARIVAX (Merck) was exposed to unknown temperatures for 5 hours during interoffice transport. The patient was revaccinated. No adverse symptoms reported. This is one of several reports from the same source. Additional information is not expected.
Received a monovalent dose after FDA  released statement that monovalent was no longer to be used.  We have now administered a Bivalent Dose on 5/11/2023 per Interim Clinical Considerations for use of COVID 19 Vaccines.
This spontaneous report has been received from a physician via a company representative, concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On approximately 10-MAY-2017 (reported as about 2 weeks ago), the patient was vaccinated with a dose of with GARDASIL 9 injection (dose, frequency, route of administration, lot# and expiration date were not provided) for prevent human papilloma virus (HPV). It was unknown which .5 ml dose in the GARDASIL 9 series the patient was given and if the patient was going to complete the series or not. It was stated that, the patient's mother called the physician's office, as a way of seeking medical attention for the patient, who was experiencing swelling and pain at the injection site after receiving the dose of GARDASIL 9. It was unknown if the patient received any treatment or if diagnostic laboratories were performed. At the time of the report, the outcome of the patient was unknown. The causal relationship between the therapy with GARDASIL 9 and the events of swelling and pain at the injection site was unknown. There was no product quality complaint involved. Additional information has been requested.
16APR94 about 2PM noticed itching on scalp; as the evening progressed hives & swelling occurred over entire body; from head to foot; MD called erythema multifore & prescribed bed rest w/Pred, Hydroxyzine;
Patient experienced severe dizziness 5-10 minutes after receiving injection. Also complained of drowsiness. Unable to stand as a result of dizziness.
Sharp pain in armpit with lymph node swelling for the first 2-3 days (2/9/22 through 2/12/22) following Pfizer COVID 3rd dose on 2/8/22, with onset of severe ache in left shoulder that began around 2/12/22 with radiating 8/10 pain down left arm that does not seem to be eased with OTC anti-inflammatory medications. Comfort not found with positioning of arm/shoulder nor heat/cold compresses.
Dizziness; Mild fever; Tiredness; Mental fatigue; lack of sleep; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 04Feb2021 (lot number: EL9269) at 14:45 at single dose for COVID-19 immunisation. The relevant medical history included cancer and known allergies: One prescription nasal spray. Concomitant medications were not reported. The patient experienced dizziness, mild fever, tiredness, mental fatigue, lack of sleep on 04Feb2021 at 03:00 PM. No treatment was received for the events. The patient underwent lab test included nasal swab on 06Feb2021 which was pending. The outcome of the events was not recovered.
Case number PHEH2014US02020237 is an initial spontaneous report received from a health care professional (also patient) on 01 Oct 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. Her vaccination history included administration of other vaccines such as tetanus booster (unknown manufacturer, batch number: not reported) on unknown date and was well tolerated. She also received FLUVIRIN (batch number: not reported) intramuscularly in the past (unknown number of doses) and experienced events (see related case numbers: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236).  She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on unspecified date. It was reported that on an unknown date after vaccination, her arm was swollen, red and hot. The outcome, seriousness and causality of the event were not reported. She was also vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in next 3 years and experienced similar events (see related case number: PHEH2014US020238, PHEH2014US020239, PHEH2014US020240).
3/9/2021 After first vaccine I had brain fog, bowels hurts/stinging, headache, fatigue (just like the illness), I felt better in about five days. About two weeks later I had an increased/altered sense of smell/taste to certain things such as banana?s, tequila, Baileys Irish Cream, certain sweet foods/fruit (but not ice cream). Other altered smells: Dawn dishwashing soap, Clothes washing detergents three brands (Tide, Arm& Hammer, and Gain). Belching caused the taste to be sensed. Most of the smell/taste had returned to normal in about four weeks (right before the second vaccine).
Soreness at injection site; Clumsiness; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 16:15 (Lot number: EN6200) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVALBUTEROL [LEVOSALBUTAMOL]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "Soreness at injection site"; CLUMSINESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Clumsiness". Therapeutic measures were not taken as a result of vaccination site pain, clumsiness. The reporter considered "clumsiness" not related to BNT162B2.  Additional Information: The only side effect of first shot the patient noticed was soreness at injection site, though she did note that she had a period of inexplicable clumsiness for about a week but did not think related.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: based on the known safety profile of vaccine and the information available the event CLUMSINESS was considered unrelated to the suspect drug.
wants to know how long does the pain in the arm should last for a pateint that 2 years after the vaccination still has pain.; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date in 2017 at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  It was reported that 2 years after the vaccination, patient still had pain in the arm. The pharmacist wanted to know how long did the pain in the arm should last for this patient that 2 years after the vaccination still has pain. Outcome of the event was not recovered. Information on the batch number has been requested.
Vaccinated against smallpox on 3/20/03. Began to experience RUQ pain approximately 3-4 days after being vaccinated. Pain described as mild, intermittent. No other signs or symptoms. Had this intermittent pain up until 3-4 months ago. Is a physician. Was not seen by  another physician or evaluated.
Two day later..beginnings of symptoms ..of what would turn out to be...Appendicitis...     shot on Thurs ..Appendicitis symptoms late morning Sat        Emergency Appendectomy...Mon Eve
While in observation area. Patient complain of itching and redness to bilateral arm.  vitals 125/73 HR 76 02:96%RR 18 Brought to nurse station. complain of new onset of throat itching Benadryl 50 mg PO administered. Observed for additional 40  mins. patient reports "throat itching " resolved and improvement of bilateral arm itching . Bilateral arm remain with small areas of redness which has improved since initial assessment. d/c home no acute distress ER precuation Pt verbalized understanding (Patient verbalized is following an Allergy specialist that cleared him for initial vaccine administration, patient educated to follow Allergist prior to second dose administration)
Found out that he received Pfizer Vaccine; Shivering,Chills; Nausea continuing; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Found out that he received Pfizer Vaccine), CHILLS (Shivering,Chills) and NAUSEA (Nausea continuing) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. E1269) for COVID-19 vaccination.     Concurrent medical conditions included Hormone therapy.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Shivering,Chills) and NAUSEA (Nausea continuing). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Found out that he received Pfizer Vaccine). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WRONG PRODUCT ADMINISTERED (Found out that he received Pfizer Vaccine), CHILLS (Shivering,Chills) and NAUSEA (Nausea continuing) had resolved.            Concomitant medications taken were hormones injections.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up information was received on 21 May 2021 in which first dose details and new event nausea was added. On 06-Aug-2021: Follow-up information received: Event outcome updated
Pt. called nurse over and stated that he was sweating and did not feel well. pt's skin pale
Lightheadedness, headaches, and tingling to Left side of face. 1400 V/s Bp 135/82, Pulse 79. A 61 year old white female received second moderna vaccine. Lot #022M20A to left deltoid. 1415pm patient c/o lightheadedness, headache, and tingling to L side of face. Patient states that she suffers with panic attacks. Observed patient for 30  mins. Re-assessed  patient at 1425pm V/S Bp 1139/86 L deltoid pulse 80. Gave patient a bottle of water and encouraged to deep breathing. 1440 patient states she will be okay and she lives 2 minutes away from facility. Patient ambulatory and EM able to ambulate without any assistance. No other c/o voiced. Patient left facility at 1445pm.
patient received an expired vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Medical Information (Reference number- 00355051) via call center and transmitted to Sanofi on 11-Nov-2020.  This case involves a female patient (age not reported) who received vaccine IPV (VERO) [IPOL] (batch number: P1E70, expiry date: 09-Nov-2020) via an intramuscular route in right thigh on an unknown date for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP); HIB VACCINE (HIB); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event was reported.  Caller would like to know if the patient needed to be revaccinated.  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.
tested positive for covid; cough; nausea; fever; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), COUGH (cough), NAUSEA (nausea), PYREXIA (fever) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and ZINC for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced COUGH (cough), NAUSEA (nausea), PYREXIA (fever), HEADACHE (headache) and FATIGUE (tired). On 30-Mar-2021, the patient experienced COVID-19 (tested positive for covid). The patient was treated with CEFDINIR at a dose of 1 dosage form and PREDNISOLONE at a dose of 1 dosage form. At the time of the report, COVID-19 (tested positive for covid), COUGH (cough), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (tired) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medications also include-  allergy pill.
Muscle and joint pain, weakness, fatigue. Soreness pain at vaccination site and left arm. Fever 100 degrees Severe the first 3 days, continued 4 more days and intermittent since then with nausea,
pt recv vax 17APR98 & sx started w/in 8hr irritability, vomiting, gastric cramps, T102.4, chills lasting 24hr;fatigue has cont for 2wk;
redness, swelling and pain at injection site for 2 weeks stomach issues for 2 weeks very tired & felt like a lead weight for 3 weeks
Fever; Chills; Fatigue; Muscle aches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-013926 (Patient Link).
Shingrix Dose #1 given 9/8/20 L deltoid no reaction.  Patient had Covid Vaccine series 12/22/20 and 1/13/21 both L arm per patient request.  No reaction at that time. She has considerable tenderness, swelling, numbness and tingling at the injection site which tends to radiate down her left arm.   Sometimes the symptoms occur with movement of her arm but other times it is nonpositional and can occur spontaneously She had some poison ivy or perhaps poison oak last week for which she did take prednisone 20 mg daily for 3 days and as needed hydroxyzine to sleep but noticed no change in the symptoms of her left arm. She has had severe crippling myalgias from number of statins to include Crestor, Pravachol and Lipitor.
1. Fever started next day 1 PM (From Monday). High fever (102) for 2 days. Subsequent fever (100.4) every night. 2. Severe Throat pain started after 2 days (From Tuesday). Still continuing (reporting on Saturday 11 AM).   Treatment: Giving Tylenol (500mg) SOS basis. 1 tab daily Levocitrizine 5 mg  from Friday night.
It started with extreme dizziness to the point I felt I was going to fall. I feel unsteady on my feet sometimes especially in the first couple of weeks when every time I would bend down to pick something up I felt I would fall from the pressure like spinning. That sense of disequilibrium  comes and goes. Sometimes I feel like my head is spinning. This happens even if I'm sitting and has even happened when I am lying down. I get weird pressure headaches out of nowhere. Last week I the pressure in my head from sudden headache was so bad my ears (ear canal) started pounding.