chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a other health professional (nurse) refers to a 76 year old female patient. Patient's medical history and drug allergies were not reported. On 06-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 in the left arm (Lot # 018528, expiration date: 14-APR-2016) for routine administration. Concomitant medications were not reported. On 06-JAN-2015, patient experienced cellulitis in her left arm. Patient's arm hurt and she was in pain. On an unknown date, patient sought medical attention and went to see the doctor. No treatment was given for the adverse event. Outcome of the event was reported as not recovered. No product quality complaint (PQC) was involved. Causality assessment was not provided. Additional information has been requested.
skin sensitive to touch (like with fever); low grade fever; muscle aches; night sweats; dizziness; stiffness in neck and left side of body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 at 11:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown"; PYREXIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "low grade fever"; MYALGIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "muscle aches"; NIGHT SWEATS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown"; HYPERAESTHESIA (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "skin sensitive to touch (like with fever)"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 11Sep2022 at 23:30, outcome "unknown", described as "stiffness in neck and left side of body". Therapeutic measures were not taken as a result of hyperaesthesia, pyrexia, myalgia, night sweats, dizziness, musculoskeletal stiffness.  Additional information: 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;devel a localized rxn that consisted of erythema, induration,localized tenderness & myalgia at inject site; low grade fever of 99; tx w/ naprosyn;
Patient presents to Clinic with 2.5 inch by 2.5 inch hard, red, raised area to left deltoid.  Patient states that the area is very itchy as well.   Also compains of right arm being extremely painful and that she passed out while receiving the vaccine (Bexsero) on 09/14/2020.
Janssen COVID-19 Vaccine EUA Fever of 101.3 for over 24 hrs.  Only could control with Tylenol.  Once I stopped, fever would spike up. Severe joint pain Headache Severe pain at injection site for 48 hours Burning eyes Uncomfortable urination
Within 15 minutes of vaccine administration, I got a metallic taste in my mouth, itchy tongue, throat, ears, then burning of mouth, tongue throat, migraine, numbness/loss of feeling in both hands and left foot, panic attack, chest pain, SOB, extreme nausea, loss of appetite
Upon the administering of the 2nd Hep B shots and 1st polio shot, patient lost almost all his hair.  After 1st Hep B shot on 05/10/2000, patients thyroid was borderline high until 23:00.  Patient also show slight signs of mild autism.
Running nose; Tickle in my throat; Slight fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose), THROAT IRRITATION (Tickle in my throat) and PYREXIA (Slight fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Running nose), THROAT IRRITATION (Tickle in my throat) and PYREXIA (Slight fever). At the time of the report, RHINORRHOEA (Running nose), THROAT IRRITATION (Tickle in my throat) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified
bubbling of the supraclavicular lymph node in the same arm following a GARDASIL 9 administration; This spontaneous report was received from a physician referring to a male patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant medication were unknown.  On an unknown date, the patient started HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, anatomical location, route of administration, exact indication, lot #, expiry date were not reported) as prophylaxis.   On an unknown date, the patient experienced bubbling of the supraclavicular lymph node in the same arm (Lymphadenopathy) following a HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administration. On an unknown date, the patient recovered from the event (reported as the condition resolved on it's own and has not come back). The action taken with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causal relationship between the event and the suspect therapy was unknown.
she felt really really weak; After her Moderna shot she felt sick during approximately a week and a half; the arm where she received the shot hurt so bad and also her chest; she was throwing up; the arm where she received the shot hurt so bad and also her chest; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (she felt really really weak), ILLNESS (After her Moderna shot she felt sick during approximately a week and a half), CHEST PAIN (the arm where she received the shot hurt so bad and also her chest), VOMITING (she was throwing up) and PAIN IN EXTREMITY (the arm where she received the shot hurt so bad and also her chest) in a 71-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No listed conditions relevant medical history or conditions, allergy, concomitant diseases and risk factor.  Previously administered products included for Product used for unknown indication: Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    In 2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (she felt really really weak), ILLNESS (After her Moderna shot she felt sick during approximately a week and a half), CHEST PAIN (the arm where she received the shot hurt so bad and also her chest), VOMITING (she was throwing up), PAIN IN EXTREMITY (the arm where she received the shot hurt so bad and also her chest), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIMENHYDRINATE (GRAVOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (she felt really really weak), ILLNESS (After her Moderna shot she felt sick during approximately a week and a half), CHEST PAIN (the arm where she received the shot hurt so bad and also her chest), VOMITING (she was throwing up) and PAIN IN EXTREMITY (the arm where she received the shot hurt so bad and also her chest) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   She already received 3 Pfizer shots, then 1 Moderna COVID-19 Vaccine on 2022 and after that she received another Pfizer COVID-19 Vaccine but she did not remember specific dates for each vaccine. After her Moderna shot she felt sick during approximately a week and a half, she was in bed, she was throwing up, the arm where she received the shot hurt so bad and her chest, and she felt weak. She took Tylenol and Gravol for her stomach.
Vomited in my sleep. Was unable to inhale for perhaps 45 seconds after inhaling vomit after 2nd dose. I was also unable to leave home for about 36 hours with severe headache, nausea, body aches and fever after both doses.
Pt should have received the 2nd Moderna Vaccine instead or the Johnson % Johnson.  Medical records marked that the patient wanted the Johnson Vaccine on the form instead of checking the patient record. I missed this as well
The pt's father states that his child had a febrile convulsion yesterday. He was taken to the hospital for evaluation. Diagnosed with febrile convulsion and mother treated him with Tylenol. Father also stated that the child is doing well and seizure free.
Tdap given at 3:20 then titers drawn, during 2nd and third vial of titers client unresponsive, body stiff and jerking, eyes closed and mouth drawn in, hands, arms and legs/feet tight and drawn inward while needle in right hand, needle removed and client positioned on mat on floor with legs up. 911 called. 3:45 unresponsive - seizure about 4 minute, EMS on site at 3:50 pm.
Patient administered monovalent covid 19 booster dose instead of intended bivalent dose.  He was contacted by provider, informed of the error, discussed potential adverse outcome and counseled regarding option to repeat dose, based on medical history and patient preference, and appropriate interval for repeat dose with bivalent booster.
HEADACHE; SOMETIMES LOOSE MEMORY; HIGH BLOOD PRESSURE AFTER VACCINE; DIFFICULTY BREATHING; FEELING ABNORMAL; LOOSING WEIGHT; VOMITING; MY TONGUE WAS SWOLLEN; POOR  APPETITE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included blood pressure abnormal, and concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies or drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1200287383 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sometimes loose memory. On APR-2021, the subject experienced high blood pressure after vaccine. On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced feeling abnormal. On APR-2021, the subject experienced loosing weight. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced my tongue was swollen. On APR-2021, the subject experienced poor appetite. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, fatigue, sometimes loose memory, high blood pressure after vaccine, poor appetite, nausea, vomiting, loosing weight, and feeling abnormal, and the outcome of my tongue was swollen and difficulty breathing was not reported. This report was non-serious.
Suspected vaccination failure; Received Shingix and experienced shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The health care provider called asking for information about Shingrix causing shingles because he had a patient that heard that another patient received Shingix and experienced shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided
Tinnitus.  Ongoing to this date.  I have no hearing loss.  No other possible causes were determined to exist.
Initial report received from a non-healthcare professional on 10-Oct-2013. A 74-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number: U47117AA and route was not reported) on left deltoid on 16-Sep-2013. On 17-Sep-2013, patient had sore arm. Patient has not seen a physician. Patient experienced pain at the injection site, into the muscle. She had difficulty dressing herself. Patient was slowly getting better. The events were recovering. List of documents held by sender: none.
1.5 hours after receiving her flu shot she developed sudden tingling and numbness in her chin and lower jaw. No hives or rash. No symptoms of throat swelling. No hoarness or wheezing.  Symptoms isolated to her jaw.  Spoke with client today 11/10.  She is doing fine symptoms are gone.  They lasted for several hours after her flu shot.  She last had a flu shot 4 years ago
Developed swelling, redness, rash and cellulitis of left arm, progressed to side of chest. On 12/17/02, Rx'd with dicloxacillin. By 12/19/02 was improving. On 12/20/02, had more improvements. On 12/23/02, much improved.
At 30 minutes - noticed my face was flushed and a little bit red - but it went away pretty quickly. Within 45 minutes - noticed breathing issue - shortness of breath and it continued to get worse. Had shortness of breath when I worked on Monday but I used my Rescue Inhaler. Woke up on 2:00 am on Tuesday - had fever - 101 degrees (took Tylenol for fever), body aches, neck ache and shortness of breath. Had to get COVID testing (January 5). By 3:00 afternoon Tuesday - all the symptoms went away except shortness of breath. Had to sleep sitting up in chair - as I couldn't lay down due to shortness of breath. It lasted about 3 weeks.  I called Dr.( a second time - the first time the first provider said to watch it and wait)  on January 15 and she wanted to start me on Prednisone. She put me on a 5 or 6 day dose of that.
Pt reported possible adverse event at 1500 on 10/22/03. "Facial flushing, sensation of throat closing, intense redness from below L ear to L shoulder to L mid-forearm, some swelling and terrible itching." Self medicated with Benadryl.
Repeat symptoms of 1st shot. Severe nausea, dry heaves with little emesis. Chills,sweating,rigors,weakness..unable to pick headercause of nausea. Tachycardia.
Fever 99.9 F, chills, nausea, vomiting, body aches, injection site soreness
Systemic: Rash (other than injection site)-Medium; Systemic: Other- half face swollen several hours later; symptoms lasted 1 day.
Pt chief complaint of change in mental status and fall. Pt. diabetic concerns for hyperglycemia and pt is COVID+ Pt shrotness of brath and fatigue. Pt deteriorated required ventilation and dialysis .
an 85 y.o.  female with a PMH significant for HTN, atrial fibrillation (on Coumadin), GERD, thrombophlebitis, obesity (BMI 38), pulmonary embolism, CAD, cardiomyopathy, MI s/p CABG, breast cancer and osteopenia with chronic pain who presented to the ED with chest pressure radiating to the left arm that started earlier this afternoon.  She currently resides in a local nursing home where she was recently admitted for rehabilitation after a recent hospitalization for a fall that exacerbated her chronic knee pain. Patient stated that she was lying  in her bed getting "worked up" and frustrated because the nurses were not answering her call bell when she began to feel  pressure in her midsternal chest that radiated to her left arm.  She described the pain as constant.  Notably, prior to her last MI, she described a similar feeling of pressure that was intermittent.  She denies having shortness of breath, dizziness, nausea or vomiting at the time.  She was given sublingual nitroglycerin and got relief.  During my interview and examination in the ED, patient had no complaints of chest pain or shortness of breath, she complained only of chronic pain in her right knee and in her left arm that is relieved only with medication
Headache SORENESS AT INJECTION SITE DAYS 1-3 AFTER INJECTION. FATIGUE AND HEADACHE DAYS 3-5 AFTER INJECTION Narrative:
Pfizer Covid-19 vaccine administered on 04/05/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Painful blister type rash formed on septum and neck. Rash appeared unexpectedly and still is present and painful. Rash would crust up for several days.
Pt vax w/ 3 hepta B; did not respond.  Titer checked, non responder.
SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak; My immune system has not returned to normal yet; I still have a severe rash; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak), IMMUNE SYSTEM DISORDER (My immune system has not returned to normal yet) and RASH (I still have a severe rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose Number 1, Batch/Lot No EW0150, Location of injection: Left arm, vaccine Administration Time: 03:45 PM) on 01-Apr-2021, Pfizer (On 22-Apr-2021 at 03:45 PM, Second dose, Batch number: EW0164 and Anatomical Location: Left arm.) on 22-Apr-2021. Past adverse reactions to the above products included Allergy with Pfizer; and No adverse event with Pfizer.    In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak), IMMUNE SYSTEM DISORDER (My immune system has not returned to normal yet) and RASH (I still have a severe rash). The patient was treated with DUPILUMAB (DUPIXENT) at an unspecified dose and frequency. At the time of the report, ECZEMA (SEVERE ecezma outbreak occurred all over my body/ It lead me to get Moderna as my booster in January of 2022 but that also caused an outbreak), IMMUNE SYSTEM DISORDER (My immune system has not returned to normal yet) and RASH (I still have a severe rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, Nasopharyngeal swab: negative (Negative) Negative.         It was reported that the patient received booster dose of Moderna in January of 2022 but that also caused eczema outbreak (patient  was told to expect this). Patient immune system has not returned to normal yet. Patient still have a severe rash.  Concomitant medications details were not reported by the reporter.  Patient received bed ointment as an corrective treatment as prescribed by the doctor.  Device Date was reported as 27-Apr-2022.
had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am) and MYALGIA (sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), CARVEDILOL (COREG), APIXABAN (ELIQUIS), ASPIRIN [ACETYLSALICYLIC ACID], MELATONIN, IRON POLYSACCHARIDE COMPLEX (FERREX) and UBIDECARENONE (Q-10 CO-ENZYME) for an unknown indication.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced MYALGIA (sore arm). On 17-Sep-2021, the patient experienced DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am). At the time of the report, DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am) and MYALGIA (sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am) to be unlikely related. No further causality assessment was provided for MYALGIA (sore arm).    Other medications also include Men's Vitamin. No treatments were reported. Patient reported they ate tacos ,diarrhea may be due to this or shot.
Information has been received from a registered pharmacist concerning a patient who on 09-APR-2010 was vaccinated with a dose of VARIVAX (Merck) instead of a dose of ZOSTAVAX (Merck) (MSD). The patient was not experiencing any known symptoms. Additional information has been received from a registered pharmacist who received the original report from a registered nurse indicated that the patient received VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD) due to a medication error. Additional information has been received from a registered pharmacist indicated that the VARIVAX (Merck) Lot# was 665880/1299Y. Additional information has been requested.