chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives on her right arm further down where she got the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (hives on her right arm further down where she got the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021 at 1:30 PM, the patient experienced VACCINATION SITE URTICARIA (hives on her right arm further down where she got the injection). At the time of the report, VACCINATION SITE URTICARIA (hives on her right arm further down where she got the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided.  No treatment medication details was provided.
One week of flushing and heart racing; followed by one week of extreme muscle stiffness on left side; followed by stroke-like symptoms and 3 weeks (and continuing) of numbness on the left side only.
2/20/14 Presented to ED with maculo papular rash entire body with few pustules present. RN states, child acts like they are in her throat also. Started breaking out 2/10 in the arm on face and started worsen last nite. More so this am. Was given picture of child shows "huge welts" like rash. BENADRYL 6.25 cc po. Prelone 10.2 cc po.
I started feeling really tired, like I couldn't stay awake. It is still continuing until this day. I have started medication that has helped with it. I also gained 25 pounds in two months.
Patient passed away on 4/13 after presenting to local hospital with near syncope and AKI.  Records from local hospital are unavailable, unclear regarding cause of death and circumstances thereforth.
This spontaneous report as received from a physician refers to a 65 years old male patient. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 01-NOV-2012. Other suspect therapies included Influenza a dose of Virus Vaccine (manufacturer unknown) (lot #, dose and route not reported) on 01-NOV-2012. No concomitant medications were reported. The physician reported that the patient had a fever, tremors, shakes, nausea, vomiting after getting the shots. He was seen in the emergency room two days after the getting the shots (on 03-NOV-2012). No treatment was given for the events. The outcome of tremors, shakes, vomiting, had a fever and nausea was unknown. The relatedness for the reported events was not provided for ZOSTAVAX and Influenza Virus Vaccine (manufacturer unknown). Additional information has been requested.
A consumer report has been received. The report concerns an adult, male consumer who had been receiving FLUMIST Quadrivalent started on an unknown date. The patients one eye turned pink 2 hrs after FLUMIST administration which started on 18-OCT-2014. At the time of reporting, the event of one eye turned pink 2 hrs after FLUMIST administration was ongoing. The report was considered to be non-serious.
Fever, chills, muscle and joint pain, extreme fatigue, nausea. Pain and stiffness at injection site.
I still have one more to go; arm hurt, hurt bad; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (everyone in family had shingles multiple times).   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain in arm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got a shot a few years ago but this summer the patient visited to clinic and said he/she needed the new shot that hurt bad, his/her arm hurt for a week and patient still had one more dose to go. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Acute arm pain to the point that I was unable to use the arm without significant pain. I braced the arm to my stomach like wearing a sling. It was significant until 1/13/21. I was unable to do any task that required engagement of those arm muscles. I also had fatigue (2 to 3 naps a day) and loss of appetite. I missed 2 days of work 2 days after vaccine. I took 600 mg to 800 mg of ibuprofen and used an icepack.
Information has been received from a medical assistant concerning a 28 month old female patient who was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
I received my vaccine April 11th at 3 p.m and began to have a fever around 9 p.m.  My fever did not go away until the next evening. On April 12th I had a fever and woke up with red little dots around my eyes.  At night the fever went away. The following day April 13th I felt my chest tight and had shortness of breath throughout the day. I also had stomach pains at times.  April 14th and 15th (today) my chest still feels tight and I get tired very easily.  My arm is also still very sore and sensitive, I have a little bump where the vaccine was put in.
Generalized sz- day p/OPV/DTP eyes rolled back; Arms, legs jerking recovered w/out tx; lasted about 2min; CT scan-nl; subsequent sz recurrences now on meds;
runny nose; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, Expiration date unknown), via an unspecified route of administration on 06Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had her 1st dose on 06Feb2021 and 2nd dose is scheduled on 27Feb2021. She wanted to know more information about the 2nd dose. Patient experienced a runny nose and chills yesterday on 23Feb2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 23-SEP-2013, the patient was vaccinated with GARDASIL (lot# J003727 and expiration date 07-NOV-2015 (also reported as 08-NOV-2015). It was reported that the vaccine was improperly stored and was exposed to below 31.6 Fahrenheit from 09-SEP-2013 to 23-SEP-2013. No further information was available at the time of the report. The case is linked to 1312USA001445, 1312USA008847, 1312USA008940, 1312USA008941, 1312USA008943, 1312USA008944, 1312USA008945 (Same reporter link). Additional information has been requested.
Back pain 3 hours post injection - ongoing pain radiating onto groin and tingling both hands.
This case was reported by a consumer and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. The patient was treated with BENADRYL. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced adverse reaction to 2nd dose of SHINGRIX (all of the indications mentioned: not further specified). The patient contacted pharmacy, the day after shot, described the condition to them and they recommended BENADRYL, and all was well at the time of reporting.
Pt. had appt on 10/29/12 Influenza vaccination and pneumococcal vaccination were administered. Pt. returned 10/30/12 stating his left arm was in pain. Pt. was unable to lift arm without difficulty. No swelling or redness at injection site.
1/20/20 extreme fatigue at work and got lost/confused on drive home,  weakness, uncoordinated, admitted to hospital 1/26 with stroke like symptoms,  still to date 3/8 ongoing neurological issues, weak tingling limbs, memory/focus, speech, balance, extreme fatigue, unable to drive or work, unsteady if on feet for more than short amount of time, spacial awareness off sometimes run into objects and miscalculating placing items back on shelves
Pt lost consciousness in chair initially.  She was in and out of consciousness.   She was moved to cot from the chair.  Supine position and lower extremities elevated.  Pt was provided juice and snack after she was stable.   Observed for 30 mins.  Pt stable and released from the vaccination site.
Pt recv vax & 7 day p/vax devel "grape sized lump in her neck,right side under mandible". MD dx infected salivary gland tx w/Keflex 125 mg x 10 day. 3 day p/tx, pt presented w/enlarged nodes in left groin area; groin nodes remain enlarged
possible cellulitis; redness; severe swelling; blisters; Initial information was received on 08-Aug-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves 11 years old female patient who experienced possible cellulitis, redness, severe swelling and blisters after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  On 31-Jul-2023, the patient received a dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot U763b2A, strength, expiry date unknown) via intramuscular route in unknown administration site for prophylactic vaccination (Immunization).  On 01-Aug-2023 the patient developed a serious event of possible cellulitis and non-serious events of redness (erythema) , severe swelling and blisters (blister) (latency: 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  There were no lab data/results available.  Action taken with meningococcal vaccine (Menquadfi) was not applicable.  It was not reported if the patient received a corrective treatment for the events (redness, severe swelling, possible cellulitis, blisters).  At time of reporting, the outcome was Recovered on 02-Aug-2023 for all the events.  Seriousness criteria : Medically significant for possible cellulitis.; Sender's Comments: Sanofi Company Comment dated 08-Aug-2023 : This case involves 11 years old female patient who experienced possible cellulitis, redness, severe swelling and blisters after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Pt was seen on 06/09/21 for her 1st  Pfizer vaccine.  I went to the med room to draw up this vaccine. I documented on the form  in the med room, with the patients sticker.  I drew up the vaccine,  I accidently drew up the dilute with the 1mL syringe instead of the 3 mL syringe. 1.8mL. I added this to the vaccine and drew up 0.3mL . I then went to get the patient, asked the questions on the form and gave the injection.  The Patient then waited the 15mins.   It was discovered on 6/10/21 that the wrong syringe was used to draw up the dilute.  I spoke with my provider and he stated that he feels the patient got enough of the vaccine to be effective.  The patient is returning to the office on June 30th  for her 2nd Pfizer vaccine.   There were no adverse events with this patient.
VERTIGO BUT NOT DIZZINESS; WHEN LEANS OVER ALMOST FAINT; INCREASED JOINT MUSCLE PAIN (HAS ARTHRITIS); TIREDNESS; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced vertigo but not dizziness. On 10-MAR-2021, the subject experienced when leans over almost faint. On 10-MAR-2021, the subject experienced increased joint muscle pain (has arthritis). On 10-MAR-2021, the subject experienced tiredness. On 10-MAR-2021, the subject experienced slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vertigo but not dizziness, when leans over almost faint, tiredness, slight nausea, and increased joint muscle pain (has arthritis). This report was non-serious.; Sender's Comments: MAC not required per standard procedure as the case assessed as non-serious.
Recieved Hepatitis A vaccine in arm and developed a large red knot, next day whole arm red and swollen, very tender to touch, and was red. She was given Naprosyn 500mg by mouth three times per day, That evening had a reaction to the Naprosyn
Rash on back behind bra strap.. Feels achy and tired but not feverish.
It started with hand twitching the same week I got the Pfizer shot which I assumed was unrelated. Then on 4/17 I noticed an internal vibration sensation. This internal vibration sensation persisted and became more frequent (chest, lower half of head predominantly but sometimes whole body as well). April 23 to 25 was happening a lot even while sleeping. On April 23 I went to Urgent care for unexplained high blood pressure, ran tests, and was released. Consulted doctor on April 26 about high blood presure and internal vibration sensation (unclear if related) and ran more tests. Still unclear cause. Will see if symptoms continue to improve.
ACUTE NON ST ELEVATION MI 3/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Slight temperature elevation on day of immunization.  For 3 days refusing to eat.  The child acts hungry, goes to the breast, then becomes fussy and pulls off.  Spitting up more than usual.  Taken Zantac for GER.  Weight loss of 1 oz over 3 days.  Wegith on 01/26: 10lbs, 11oz.  Weight on 01/29: 10lbs, 10 oz.
The patient received a flu shot at our pharmacy in November 2,2020 (Monday). She came back November 4,2020 (Wednesday) to inform us that, after reviewing her medical records at home, her primary physician had already administered a flu shot (Fluarix=lot P100251770,exp07-30-2020) in September 17,2020. She was feeling OK ( no side effects), but was very nervous. We provided counseling about the situation and told her to call us or her primary physician in case she had any concern. Apparently, she was interested in receiving the tetanus toxoid vaccine. But, when the pharmacist is ready to administer the vaccine she/he always asks the patient her/his name and tells her/him what vaccine is going to be administered and where it is going to be administered. Asks if it's OK and proceeds.
Fever only up to 102 degrees 1 day later.  The patient came today at 5 years of age with complaint of elevated temperature for 2 days it  has resolved today.  Of note is the fact that the child did receive the FLUMIST vaccine on September 10 and developed a temperature elevation on September 11.  Her temperature is gone of 202 degrees with no other specific complaints.  She has had no fever today.  She does reportedly complained of some ear pain.
Chronic Lymphocytic Leukemia; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included obinutuzumab (GAZYVA) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced chronic lymphocytic leukemia. The patient underwent lab tests and procedures which included antibody test: no antibodies on an unspecified date. The outcome of the event was unknown.   Information about the lot/batch number has been requested.
Noticed  that I needed to scratch as it itched somewhat.   Thought it was just dry skin.  Red patch 2 1/2-3 inches in diameter. somewhat sore to touch.
9/11/2021 began to have Congestion, ear pain, , post nasal drip and painful lumps on left side of ear all around. Felt throbbing of ear pain and head pain. 9/12/2021 Went to urgent care and was directed to go to ER to rule out mastoiditis.
Client arrived at health department on 11-14-06 1pm to report: Had Influenza and Td vaccination on 11-07-2006, on Friday 11-10-06 approximately 1 am, started having bad cough, drainage from sinus, hoarseness, slight headache, this lasted until 11-13-06.
Info has been received from a registered pharmacist concerning a female pt in her late 50's who on 03/10/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. On 03/11/2003 the pt developed a severe headache, lightheadedness and a "huge knot-like swelling at injection site". Unspecified medical attention was sought. Additional info has been requested.
Inappropriate reconstitution technique; Wrong solution used in drug reconstitution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On 1st November 2019, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication and wrong solution used in drug reconstitution were unknown.  Additional details were received as follows: The age at vaccination was not reported. On 2nd October 2019, clinic nursing staff noticed a box with a single vial of diluent only left.  The vaccines was vaccinated the day before the reporting date and there was no way to discern which patient received Menveo reconstituted incorrectly men A reconstituted with sterile water as diluent, which led to inappropriate preparation of medication and wrong solution used in drug reconstitution. These patients were then re-vaccinated with Menveo. This case 1 of 22 cases reported by the same reporter.
enlarged and painful lymph node; enlarged and painful lymph node; rash on right arm in the area of the shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) for 1 day as 2nd dose, single dose for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "enlarged and painful lymph node"; VACCINATION SITE RASH (non-serious), outcome "unknown", described as "rash on right arm in the area of the shot". Description of Event: 24 hours after the second Pfizer Covid-19 vaccine, patient experienced enlarged and painful lymph node under right armpit which was the same arm the vaccine was given. Patient also noted rash on right arm in the area of the shot.  No follow-up attempts are possible. No further information is expected.
on the way home from clinic pt began to exp pain in nose & mouth;swelling began in nasal passages but no diff in breathing or swallowing;advised to go to ER for eval;pt eyes began to swell;DPH given;
3 Doses of HEPLISAV-B; Initial Report Received on 19-Nov-2021  A registered dietician reported that a 86 year-old female patient (race and ethnicity unknown) received 3 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.  No relevant concomitant medications were reported.    On 16-Sep-2021, the patient from another dialysis center, received the first dose of HEPLISAV-B (Lot #, expiration date, and NDC # not available).   On 12-Oct-2021, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, and NDC # not available).  On 09-Nov-2021, the patient received the third dose of HEPLISAV-B (Lot #, expiration date, and NDC # not available). No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
HEART RATE INCREASED; BLOOD PRESSURE HIGH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) once a total dose was not reported, administered in right deltoid on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 130/something, 105/69 mmHg, and Heart rate (NR: not provided) 95-100 bpm. On 19-MAR-2021, the subject experienced heart rate increased. On 19-MAR-2021, the subject experienced blood pressure high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart rate increased, and had not recovered from blood pressure high. This report was non-serious.
Patient received Janssen vaccine while not in prison on 4/5/2021 then patient was given Moderna vaccine on 5/19/2021 once he was incarcerated. Patient denies any adverse effects