chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After received Tdap in left upper arm, patient started c/o of tightness and numbness in the left upper arm. Father in the room with the patient states he used to get this reaction when he had the tetanus shot in the past. VS recorded as temp 99.6, resp 18, pulse 70, O2 sat 98%, BP 110/70. Patient held ice pack for 10 minutes to the shot site. Patient was watched for 20 minutes after the reaction. Patient state it is resolving. Manager on call notified. Patient discharged at 4:10 PM in no acute distress, father and patient verbalizes understanding to follow up with primary care physician if any symptoms come back or get worse. Take Tylenol for temp. Drink extra fluids and rest for next 24 hours. Patient discharged with father in no distress. Follow called was made today 04/27/2015 at 9am this morning, patient and his father states no problem doing just fine.
Pain in arm beginning the evening after vaccination.  Swelling and rash that extends from shoulder to elbow beginning the following day.  On 09/24/14 vaccinated person reports that they are able to lift their arm but the swelling is still there.
patient under 60yoa received Arexvy along with Flucelvax PF, Prevnar 20, and Comirnaty on 6-Oct-2023.; more tired than normal; feeling a little flu like symptoms; achy; he stated he wasn't feeling well; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 29-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number b3302, expiry date 02-FEB-2025) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis, INFLUENZA VACCINE INACT (FLUCELVAX PFS (FLU VACCINE)) for prophylaxis and TOZINAMERAN (COMIRNATY) for prophylaxis.   On 06-OCT-2023, the patient received Arexvy (intramuscular, left arm), PREVNAR 20, FLUCELVAX PFS (FLU VACCINE) and COMIRNATY. On 06-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: patient under 60yoa received Arexvy along with Flucelvax PF, Prevnar 20, and Comirnaty on 6-Oct-2023.). In OCT-2023, the patient experienced tiredness (Verbatim: more tired than normal), influenza-like symptoms (Verbatim: feeling a little flu like symptoms), pain (Verbatim: achy) and feeling unwell (Verbatim: he stated he wasn't feeling well). The outcome of the tiredness, influenza-like symptoms, pain and feeling unwell were not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the tiredness, influenza-like symptoms, pain and feeling unwell to be related to Arexvy.  It was unknown if the company considered the tiredness, influenza-like symptoms, pain and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-OCT-2023 A pharmacist reported patient under 60 years age who received Arexvy along with Flucelvax PF, Prevnar 20, and Comirnaty.  When pharmacist spoke with patient a day before reporting, he stated he was not feeling well.  He was feeling a little flu like symptoms, achy and more tired than normal.   Pharmacist was unsure about timing of onset of symptoms but as of day before reporting he still had symptoms. The reporter consented to follow up. An under age patient received Arexvy, which led to inappropriate age at vaccine administration.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age who on approximately 08-APR-2013 about a month ago was vaccinated with ZOSTAVAX (dose, route, application site unspecified). On approximately 01-MAY-2013 within the past week 2 patients presented to physician's office with an active case of shingles in the occipital region. The outcome of shingles in the occipital region was unknown. Additional information has been requested.
Skin hives on both forearms; Could not sleep; This is a spontaneous report from a contactable healthcare professional, the patient. A 55-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 right arm on 19Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 29Mar2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 06:15, on day 3 the patient could not sleep. On 23Apr2021, at day 4 and day 5 after the second doses of COVID vaccine injections, the patient experienced skin hives on both forearms. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event skin hives on both forearms was resolved on 24Apr2021 and could not sleep was resolved on an unknown date of Apr2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
no additional information provided. No AE/ PQC reported at this time.; improperly stored temperature excursion; This spontaneous report has been received from a physician referring to a 20 months years old patient of unknown gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 18-MAY-2021, the patient was vaccinated with improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot # T033304 has been verified to be a valid lot number for hepatitis A vaccine, inactivated (VAQTA), expiration date was reported as 02-APR-2022; dose detail and route were not reported)  for prophylaxis (incorrect product storage).    The storage temperature of the vaccine was 36 degrees Fahrenheit to 46 degrees Fahrenheit (48.2 F) for a time frame of 15 minutes and 36 degrees Fahrenheit to 46 degrees Fahrenheit (48.2 F) for a time frame of 15 minutes. Previous temperature excursions were 36 degrees Fahrenheit to 46 degrees Fahrenheit (46.2 F) for a time frame of 15 minutes. The call was because of a data logger. No adverse event or product quality complaint was reported.   This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA000757:01937560 US-009507513-2106USA000712:01937562 US-009507513-2106USA000591:01937623 US-009507513-2106USA000663:01937631 US-009507513-2106USA000775:01937641 US-009507513-2106USA000689:01937651 US-009507513-2106USA000988:01937598
Pain and limited motion near the top of right shoulder, at the site of second injection.  Pain is sharp, and location of pain seems to coincide with location of shoulder tendon.  No longer able to do a full arm circle or reach far back with the right arm.  Pain occurred immediately after the second injection.  Patient could not move the arm for 24 hours after the injection, and pain has not significantly dissipated since the second injection. (First injection occurred in same arm but was not nearly as noticeable after 24 hours after first injection.)
Pruritis to hands and erythema to right arm. Rapid response initiated, patient reported to ED waiting room. Reaction resolved prior to being seen and patient checked out of ed in stable condition
Extreme fatigue started about a month after a fairly strong but typical reaction to the second Moderna vaccine dose. Since that time I have had three cyclical events with extreme muscle fatigue, vertigo, BP spike all of unknown origin. Each time I barely reach any baseline before it flares again.
Large red raised hive, itchy, painful. Given RX for medrol dosepak on 10/31/14.
This is a spontaneous report from a contactable nurse via Pfizer-sales representative. A patient of unspecified age and gender received pneumococcal PREVNAR 13, via an unspecified route of administration on an unspecified date, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced knot developed around the injection site on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Vision Loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 11-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist in pharmacy. On an unspecified date, the patient experienced vision loss. On an unspecified date, the patient was treated by a physician for the event.  The outcome of the event of vision loss was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was determined to be medically significant.
Approximately 4 days after my booster shot (Dose 3) I contracted COVID-19 and had the following symptoms: Shortness  of breath, Fatigue, Fever, Coughing, Diarrhea, Lost of taste, Runny nose. I took Nyquil for treatment and was prescribed by my physician with Paxlovid.
Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B12A and 036A21A) for COVID-19 vaccination.     Patient not ever had COVID positive test or diagnosis. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Ex-smoker (but quit several years ago). Concurrent medical conditions included Drug allergy (no list.), Allergy to molds, Pollen allergy, Bronchitis (as a kid), Respiratory disorder (her whole life), Breathing difficult (not severe) and Coughing (once per year).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BRONCHITIS (Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot). At the time of the report, BRONCHITIS (Breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the the 2nd shot) was resolving.            No concomitant medications were reported.  Patient stated that she always had breathing problems, like bronchitis which occurred once a year, but not as severe as when she got the 2nd and 3 shot. 2nd dose set her off but cleared up a bit. Seen Pulmonologist and Cardiologist that monitors her heart. Not sure if doctors believe her.  No treatment information was reported.   This case was linked to MOD-2022-642383 (Patient Link).
Cold sx 1 1/2 wks. Fever blisters, 2 scabbed over.
I felt extreme tiredness and brain fog the day after my vaccine. I also had a sore left arm for two days.
Died; 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 DEATH (Died) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding the event of death has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event of death has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Five minutes after the vaccine I had a numbness from my arm that  received the vaccine ( right arm ) , numbness traveled up to my brain, def in right ear ( still no hearing ) , stiff neck, stomach nausea ,  body aches, chills, fever, tingling in my right hand, weak and dizzy.  Still having these issues currently and gets worse at night. Been taking Tylenol every four hours. I called doctor to inform her and never called back as of yet. I didn't go to my primary Dr. because I was hoping these adverse effects would go away. It' now two days after the vaccine and still feeling very sick.
I received my first shot on 1/12/21 and felt weakness and lethargy initially.  I was not able to lift the same amount of weight nor stay on a cardio machine as I once did (I exercise daily).  It never improved.  After my second shot on 2/9/21 I began to develop symptoms of DKA (diabetic ketoacidosis).  I was awaking up at night, drinking a 40oz bottle of water and urinating every hour during hours of sleep.  I lost a significant amount of weight as well (I was questioned at work about it).  I have no family history of diabetes and I have always been lean and fit.  I went to the doctor on 2/27/21 because symptoms became overwhelming.
On 11/21/2009 patient reported hives on her knees, hands, back, buttocks, and thighs. Patient also reports bilateral hip pain with walking and weight bearing. Patient reports on 11/23/2009 hives and hip pain is improving.
15-20 minutes after injection pt felt dizzy, had a headache, nausea, and weakness. Skin cool and clammy and face was pale.  This lasted for about 1.5 hours after shot was given. Pt sent home to rest and told to seek medical help if symptoms did not start to resolve. Pt went home and took a long nap and felt better when she awoke that same day. By the next day (saturday) she only had a slight headache but felt much better.  She did not have to seek medical attention. she was able to return to work on Monday, March 15th with no other issues.
Extreme fatigue and weakness,  swelling of injection site (left arm), elevated temperature, mental confusion, complete loss of appetite ,cold sore
Shortness of breath 30 minutes after vaccination, followed by swelling in body and face, blurry vision and then 'drooping' face.
Headache, Myalgia, Arthralgia, Fever, Chills Narrative: Symptoms started day after injection
Reporting vaccine administration error. Patient given 1st dose of Moderna 15JUL2021; 2nd dose given 05AUG2021. The second dose was given before the 28 day interval.
0/20/04-PATIENT DROVE TO DRS OFFICE FOR CHECKUP. WAS FINE EXCEPT FOR A 100.3 FEVER...PATIENT VERY HASTILY GIVEN FLU SHOT OVER MY PROTESTATIONS...(DR ACTUALLY CLAIMED THAT THE SHOT WAS AMONG THOSE HE HAD 'SAVED' FROM MARCH OF 2004 AND MY DAD WAS 'LUCKY' TO BE GETTING A SHOT AT ALL, SINCE WE WERE ABOUT TO RUN OUT(!)....NAUSEA DEVELOPED LATE ON OCT 22, FOLLOWED BY GENERAL WEAKNESS, INCREASED FEVER AND SUDDEN DEMENTIA BY MORNING OF 0.25.2004...RUSHED TO EMERGENCY ROOM AT THAT POINT...FEVER SPIKES TO 104, SEIZURES BEGIN AND THE PATIENT IS 'COMPLETELY UNRESPONSIVE' IN ICU FOR 19 DAYS..INFECTIOUS DISEASE TEAM BEGINS TESTS AND PATIENT IS DIAGNOSED WITH ENCEPHALITIS....FEVER RETURNS TO NORMAL, PATIENT TAKEN OUT OF ICU, BUT WITHOUT ANY MOTOR SKILLS, OR MEMORY OF ANYTHING..INCLUDING SELF, HIS WIFE OF 60 YEARS OR ME...PATIENT PLACED IN HOSPITAL ROOM ON FEEDING TUBE AND THEN TRANSFERRED TO CONVALESCENT HOME MID NOVEMBER...PATIENT OFF FEEDING TUBE BUT NOT AMBULATORY AND WITH TOTAL MEMORY LOSS AS OF TODAY (1/28/05).  Follow up: Non responsiveness, fever, kidney failure, pneumonia, seizure (many) pt was placed on "do not resusitate" list Apr 10, 2005. From Discharge summary, nausea, weadness, dementia. msv
Localized cellulitis like reaction with entire upper arm erythema, induration at site and increased warmth where erythema occurred.
Vaccine reciepient under the age of 18 was provided Moderna as a first dose COVID-19 vaccine.
wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts; "serious pain in arm"; fatigue for "weeks"; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer (Stage 4 breast cancer). Concomitant products included EVEROLIMUS (AFINITOR) for an unknown indication.   On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY ("serious pain in arm") and FATIGUE (fatigue for "weeks"). On 11-Mar-2021, the patient experienced BREAST CANCER (wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts) (seriousness criterion medically significant). On 08-Mar-2021, PAIN IN EXTREMITY ("serious pain in arm") had resolved. In March 2021, FATIGUE (fatigue for "weeks") had resolved. At the time of the report, BREAST CANCER (wife has stage 4 breast cancer and caller states her breasts have "blown up in size" /swelling of breasts) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter states patient saw her doctor Tuesday and no new MRI was done. In 2 weeks she goes back for follow up regarding side effects she experienced. Very limited information regarding these events has been provided at this time. Further information has been requested.   This case was linked to MOD-2021-071245 (E2B Linked Report).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. MOD-2021-071245:Crosslink (MOD21-071889)
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (lot # R015745, expiry date 02-DEC-2019, dose, strength, route, vaccination site unspecified) for prophylaxis (product storage error). The vaccine was stored at a temperature between minus (-9) degree centigrade to 8 degree centigrade, (-4 degree centigrade) for time frame of 2 hours and 11 minutes. There was no previous temperature excursion reported. No adverse effects were reported. Digital data logger was involved.
pt recvd vax & immed p/2nd dose had dizziness, racing heart, h/a, nausea, vomiting, pain & lump @ inject site & was disoriented; lasted 2-3 days; resolved;
Patient developed a rash on both arms, neck and chest after vaccination.  Rash was erythematous but not hives.    Patient received benadryl, pepcid, and transported by EMS to nearest ED.
her Fibromyalgia pain came back; This spontaneous case was reported by a pharmacist and describes the occurrence of FIBROMYALGIA (her Fibromyalgia pain came back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Feb-2021, the patient experienced FIBROMYALGIA (her Fibromyalgia pain came back). At the time of the report, FIBROMYALGIA (her Fibromyalgia pain came back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.
4in wheal, redness, tenderness, swollen injection area. 2in wheal noticed night before by mother. Benadryl given every 6 hours as needed. (itching and decreased reaction.) Ibuprofen for any pain and fever.
Kidney pain, skin sensitivity, migraine and cold sweats which worsened throughout the night prohibiting sleep.  Kidney pain is continuing through the next day.  Continuing to monitor.
Patient diagnosed with COVID on 9/27/2021 by his PCP and started on steroids and doxycycline.  He received his first dose of COVID vaccine on 9/12/2021 Patient went to ED at outside hospital on 10/7/21 with calf pain and swelling, no DVT noted on ultrasound and he was discharged with crutches Patient went to ED at outside hospital on 10/9/2021 with shortness of breath and found to have multiple pulmonary emboli with saddle PE and right heart strain.  He was started on a heparin infusion and transferred to this hospital.  He was treated with heparin infusion, steroids and oxygen.  He was converted to apixaban and discharged to home.  He did not require home oxygen.
Beginning the evening of my 2nd injection I became hot in temperature and the entire next day I had a low grade head ache and my neck, shoulders, and back ached.  The morning of April 29th, other than sweating the night before, I had none of the symptoms.
Patient was given immunizations and staff had left the room. Mom called for help within 5 min for help. She stated that patient arched her back, arms and fingers twitching and passed out. Patient O2 sat was 84% on room air, pulse was 44, lips white. We placed patient in recover position, covered her. Her O2 returned to 100%, pulse 68, Blood pressure 92/68. We had her recover for a half hour and watched patient until she was ready to leave. I called to check on patient yesterday, there was no answer at home. Today I was able to reach the mother, she stated that she is doing better today and returned to school on 09/13/2017.
Dizziness, Fever, Tachycardia, chills, sweating, fatigue Narrative: