chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a female consumer refers a 69 year old regarding herself with cancer in ankle and Penicillin allergy. The patient's medical history included left leg amputated from cancer in ankle. About 2 years ago, approximately in 2012, the patient was vaccinated with ZOSTAVAX injection (dose, concentration, indication, route and expiration date were not reported). None concomitant therapy were reported. In 2011, the patient experienced redness at the injection site few days after receiving the ZOSTAVAX. On unknown date the redness evolved into what resembled a bubble that has hardened. On an unknown date the patient experienced resemble a lump in the right arm. None Lab diagnostics were reported. The patient did not received treatments for the events. On unknown date, the patient asked her relative, who is a nurse, to looked at what has evolved on her arm over the last 2 years. The nurse, told her "it is not a lymph node" but not other information was given to her. The outcome of redness at the injection site, a bubble that has hardened and resemble a lump in the right arm was reported as not recovered/not resolved. Additional information has been requested.
Chills accompanied by throbbing pain in shoulders, back, legs, arms plus headache and extreme fatigue and lethargy which lasted until 4:30 p.m. 10/14/2017. ADVIL reduced the pain, but the lethargy continued with no appetite.
pt had fever 101-104 on 16APR93 & mom called & reported fever & rash @ 3PM; instructed to take pt to MD; 22APR93 mom states took pt to ER on 16APR93 was given unk med; MD said was poss reaction to vax or an allergic react to something;
Sore right injection site Arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site Arm) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore right injection site Arm) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Sore right injection site Arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-265251 (Patient Link).
Developed bruises on my lower legs and arms; Very stinging to the touch; Miserable with the stinging sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Developed bruises on my lower legs and arms), PAIN OF SKIN (Very stinging to the touch) and FEELING ABNORMAL (Miserable with the stinging sensation) 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 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Developed bruises on my lower legs and arms), PAIN OF SKIN (Very stinging to the touch) and FEELING ABNORMAL (Miserable with the stinging sensation). At the time of the report, CONTUSION (Developed bruises on my lower legs and arms) and PAIN OF SKIN (Very stinging to the touch) had not resolved and FEELING ABNORMAL (Miserable with the stinging sensation) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
PATIENT GOT DIZZY IMMEDIATLY AFTER RECEIVING HIS VACCINE.  PATIENT APPROACHED THE PHARMACY COUNTER TO TELL US AND AT THAT POINT HE PASSED OUT AND FELL BACK LANDING ON THE FLOOR.  I HAD 911 CALLED AND ASSISTED HIM AS HE AWOKE I HELPED RAISE HIM TO A SITTING POSITION.. HE STATED THAT HE WAS VERY HOT SO I GOT HIM WATER.  HE STATED THAT HE HAD NOT HAD THIS HAPPEN BEFORE AND HAD PRIOR VACCINES INCLUDING FLU AND COVID SHOTS. HE HAD COVID IN AUGUST THIS PAST YEAR. 2021. PARAMEDICS ARRIVED WHO TOOK OVER HIS CARE. THEY CHECKED HIS BP, SUGAR PULSE ETC AND ALL WAS GOOD. HE DECIDED TO HAVE HIS FAMILY PICK HIM UP TO TAKE HIM HOME. THEY LEFT AND HIS MOTHER DID ARRIVE TO PICK HIM UP ALL WITH IN 1HOUR TO 1HOUR AND 15 MINUTES.
headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CARVEDILOL, FENOFIBRATE (ADIPEX [FENOFIBRATE]), SIMVASTATIN, TADALAFIL (CIALIS), FUROSEMIDE, SPIRONOLACTONE, ASPIRIN [ACETYLSALICYLIC ACID], CODEINE PHOSPHATE, DIPHENHYDRAMINE HYDROCHLORIDE, EPHEDRINE HYDROCHLORIDE, PARACETAMOL (OVER NITE) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Tingling in my fingers of the feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FJ1614, Expiration Date: 28Feb2022) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset Jan2022, outcome "unknown", described as "Tingling in my fingers of the feet". Therapeutic measures were not taken as a result of paraesthesia.  No follow-up attempts are possible. No further information is expected.
After the administration of the second dose of 24 hours, I had severe depression that stays for about 48 hours then reduces and start to go and come
Continued pain in my left upper arm/ shoulder - especially when lifting my arm higher then parallel to the floor. This pain only occurred after my shot; I've not previously had pain in my left shoulder. I had the Quadrivalent Flulaval Q2036 Lot#93T79 VIS Issued 08/07/2015.
Recieved vaccine 9/15. Developed redness and fever 12 hours later. Followed by heat, induration, swelling over the next two days. Day 3 (9/18) generalized itch without hives presenting on trunk, face, legs and arms.
" Covid arm"     redness, swelling and heat coming from the injection site.  on Day 9.  It is fairly mild at this point.  Feels warm and slightly tender, but not painful
pt is having intermittent numbness with pain in left arm, numbness in legs, difficulty urinating, ascending numbness from waist upward, increase in anxiety. Includes abdominal distension. Onset 4 days after 2nd vaccine. Occurs every night.
Inability to reach behind back with arm Inability to reach over head or across front of body Severe, sharp, shooting pain randomnly through upper arm Deep throb/ache in upper arm at night while trying to sleep
Not a serious side affect but noteworthy: picture available upon request.  Left  big toe nail had a blood line develop across it w/ each shot. Looked on internet for similar and all that came up was a ridge where to nail reacted to body immune response. There is such a ridge (thinning of the nail) below the 2nd shot blood reaction. Thought that you may be interested.
Hospitalization for COVID pneumonia 1/10/22-1/14/22. Treated with dexamethasone, baricitinib, Remdesivir, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
PATIENT COMPLAINED OF EXCRUCIATING PAIN IN HER LEFT SHOULDER FOLLOWING A SHINGREX VACCINE. SHE THINKS THE SHOT WAS GIVEN AT THE TOP OF HER SHOULDER.  SHE SAID SHE TOOK A PERCOCET SHE HAD ON HAND FOR THE PAIN.  THE VACCINE WAS GIVEN ON 2/14/20 AND SHE CALLED THE STORE ON 2/17/20 TO COMPLAIN ABOUT THE PAIN. SHE SAID SHE DID NOT GO TO A DOCTOR/PROVIDER ABOUT IT. SHE WAS GIVEN A FOLLOW UP CALL ON 2/18/20 TO SEE HOW SHE WAS DOING. SHE SAID MUCH BETTER. A COMPANY REPORT WAS FILED.
pt rcvd vax; pt lost her voice & exp sinus problems w/ 1st dose; pt exp recurrence of original symptoms w/ 2nd dose; w/ 3rd dose pt exp pain on left side; devel low grade fever; dry heaves; loss of voice & headache & nausea;
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam.  On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
Received vaccines earlier in day. Became fussy at night. Developed grunting and stopped breathing. Became pale and blue around the lips. Apnea approximately 30 sec. called EMS. Responded when police officer picked her up. One time temp of 100.4. Admitted to hospital.
Administration of a pediatric dose to an adult patient; No adverse events reported; This spontaneous report was received from a nurse concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB), 0.5 ml dose, lot number S002769 with expiration date 04-NOV-2021 for prophylaxis (strength and route of administration were not provided).  The nurse confirmed that the dose received by this adult patient was a pediatric dose (incorrect dose administered). No adverse events or product quality complaints (PQC) were reported.  At the reporting time, the patient's outcome was unknown. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002769; expirationdate: 04-NOV-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Received shot prior evening - woke up with rash on left arm near injection site that migrated across chest, up face and towards right eye. Similar appearing rash in groin area. Rash appeared to be contact dermatitis - red vesicular in appearance.
Pain reported numbness and pain for more than 10 days with the pain being bad at night and never going away since he had the shot he says.
headache, nausea, chills, fever that developed overnight after getting vaccine. seen in office the following day
booster; numbness in his pinky; dizziness; nausea; ringing in his ears; could not see well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Initial dose, Manufacturer unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "booster"; HYPOAESTHESIA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "numbness in his pinky"; DIZZINESS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "dizziness"; NAUSEA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "nausea"; TINNITUS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "ringing in his ears"; VISION BLURRED (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "could not see well".   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further infor-mation is expected.
Headache in back of head started day after the shot.  Was intermittent, but now 4/15 has developed into worst headache of life. Since day after vaccine had fever, diarrhea, fatigue, nausea, dizziness 4/13 had N/V.  Stomach pain today around belly button.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            no concomitant and treatment medications are provided by the reporter.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a infant female patient with no allergies who was vaccinated with a first dose of MMR II. The patient at experienced high fever, vomiting and rash and was hospitalized. At the time of this report, the patient was 20 years of age and had never received the second dose of vaccine. Unspecified medical attention was sought. At the time of report the patient was recovered. Additional information has been received from the registered nurse who stated that the there was no reaction to the vaccine and "was wrong". The patient's mother stated that the patient developed roseola the day after vaccination and the physician also diagnosed it as roseola. No further information is expected.
Injection site like a hive; Pain; Injection site swelling; Wheel like redness on the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE URTICARIA (Injection site like a hive), PAIN (Pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Wheel like redness on the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not provided). Concomitant products included HYDROXYZINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 07-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Injection site like a hive), PAIN (Pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Wheel like redness on the injection site). At the time of the report, VACCINATION SITE URTICARIA (Injection site like a hive), PAIN (Pain), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Wheel like redness on the injection site) outcome was unknown.        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.   No treatment information was provided.; Sender's Comments: This case concerns a 39-year-old female with a nonserious unexpected event of vaccination site urticaria, and nonserious expected pain, vaccination site erythema, vaccination site swelling. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Case number PHEH2014US003871 is an initial spontaneous report received from a consumer on 21 Feb 2014 with a follow-up received from the physician on 18 Mar 2014. Physician confirmed patient demographics therefore the case was processed as a valid case. This report refers to an 8-year-old female child who was inadvertently vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) at 0.5 ml on 06 Jan 2014. No adverse event was reported following the maladministration. Follow-up received from the physician on 18 Mar 2014: After receiving confirmation on patient identifiers, this case was databased as a valid case with four minimum criteria met. Therefore, the report type was changed from 'other' to 'spontaneous'. Patient demographics and dose and date of administration of FLUCELVAX were updated. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 18 Mar 2014: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "Adult product administered to child".
Patient had a subarachnoid hemorrhage and died at hospital on the afternoon of saturday April 10
pt recvd vax 26JAN94 & 27JAN94 exp fever (102 approx), chills & erythema/edema in lt deltoid area, site of inject; mom was instructed by pvt MD to given APAP;
After second dose (Feb) felt normal aches and pains and slight fever. I then developed a sharp pain in my abdomen that felt like someone jabbing me with a pencil from the inside. I told me doctor who thought it may be due to me becoming anemic (I had been practicing veganism for 3 years). I was given iron infusions, the pain lessened but was still dull at times. I then received my 3rd dose of vaccine and the pain came back with a severity I hadn't had before. This time I cannot do work at times and my energy is zapped. The pain radiates at times throughout my abdomen and to my back. I have spoken to my Dr again about the Oct 19th, she ordered an endoscopy. I have been taking OTC medications like  Omeprazole, Paracetamol, Gas X, Probiotics, to no avail. It doesn't seem tied to any particular food. Went to Urgent Care when visiting there, no help was given
Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022; Patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022,expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial was initially stored in refrigerator on 17 Feb 2022 10:00 am. The vials did not undergo any temperature excursions. It was reported that  no patients have come out with adverse events.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up document contains no new information.
Slight sore arm; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration from 02Jan2021 09:45 at single dose for Covid-19 immunization. The patient medical history included heart issues. Concomitant medications were not reported. The patient has received other unspecified medications in two weeks. The patient previously took Penecillon and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight sore arm on 02Jan2021 (15:45). There was no treatment received for the adverse event. The outcome of event was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination.  This case is non-serious.
Swollen armpit lymph nodes; This is a spontaneous report from a non-contactable other HCP (patient). A 40-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248) via an unspecified route of administration on 28Jan2021 at 15:15 in left arm as a single dose for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received in two weeks included multi vitamin and vitamin c (VITAMIN C [ASCORBIC ACID]) both taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug allergy. The patient experienced swollen armpit lymph nodes on 30Jan2021 at 10:00. Patient did not receive any treatment. The outcome of the event was not recovered.   No follow up attempts are possible. No further information is expected.
Onset of acute febrile illness 4/23/21 with upper respiratory sx, headache, cervical lymphadenopathy, myalgia. This progressed to severe sx with malaise/lightheadedness, and he was admitted to a local hospital with a diagnosis of septic shock and possible L neck cellulitis. Transferred again to other hospital where he had refractory shock and EF < 15% with global hypkinesis, and finally xferred on 4/28/21 to other hospital. Had PEA arrest in (second hospital) and in transit - resuscitated and placed emergently on ECMO. Overall, picture appears more consistent with viral myocarditis. He has recovered systolic function and is off ECMO and extubated currently.