chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 year old patient was given 0.7 ml of Fluzone HD Quad, no AE; 2 year old patient was given 0.7 ml of Fluzone HD Quad, no AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 2 years old female patient who was given 0.7 ml of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number UJ469AA and expiration date: 30-Jun-2021) via unknown route in the left thigh as prophylactic vaccination on an unspecified date (product administered to patient of inappropriate age and overdose).  Medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose (latency same day).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On Tuesday after the shot it was very sore and red. It had knotted up. There was fever. When I got up to go to work the next morning it hurt bad, I was weak and very dizzy. I was running a fever. I thought I was going to pass out. I broke out in a sweat. I called the clinic and they said that it should go away in 36hrs. On Thursday I called and they had me come so a nurse could look at it. She said that everyone reacts differently. It should go away in 36-48hrs. On Friday I had clear blisters on my hands and the arm is very swollen, red and hard and hot. I called and went to clinic. Dr looked at it said that I was having an allergic reaction to it and it was turning into staph. She wrote me prescriptions for Bactrim DS TAB 800-160, Prednisone TAB 20MG, and Triamcinolon CRE 0.1%. She told me to call her Saturday morning to let her know how it is doing. Then she said if it got worse go to the ER. She said to come back to clinic on Tuesday 9/6 for her to look at it. That is tomorrow.
MODERNA BIVALENT WAS GIVEN INSTEAD OF THE MONOVALENT, PATIENT HAS NOT HAD HIS INITIAL SERIES
Case number PHEH2014US021278 is an initial spontaneous report received from a physician on 21 Oct 2014. This report refers to a 17 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired dose of MENVEO (batch number: A12098/X12098, expiry date: not reported) intramuscularly on 21 Oct 2014. It was reported that the Men A lyophilized powder conjugate vial was expired, but Men CYW-135 liquid conjugate component was not expired. No adverse events were reported following the medication error.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported. Reported some that received the vaccine during dates given and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non Significant Follow Up Appended and Second reporter Information is updated
I am having bitter taste in mouth. Almost everything tastes and smells like some weird metal to me. I thought it will be ok in few days but its been over a month and its still the same. Even an ice cream tastes bitter and horrible.
This spontaneous report was received from a currently 48 years old female consumer reporting on herself sensitive to medication. The patient was vaccinated with a dose of M-M-R II (lot #, dose and route not reported) on an unspecified date when the patient was 5 years old. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unspecified date she developed a scab at the injection site and now had a scar. Recently on an unspecified date she had 2 titers done for measles, mumps and rubella. Both titers were low for mumps. The patient was seen in the physicians office. No treatment information was reported. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for M-M-R II. Additional information has been requested.
pt exp an area of redness & induration which started on day of inj, per pt history, then began to decrease as the days passed;no other rash, SOB, tachycardia;
Child was given HEP-B on the day he was born. He became severely jaundice, Bilurubin went up to 30. He had to be treated with lights.
This Covid Vaccine I am reporting  was the booster. I did not get adverse events with the 2 previous shots. I received the booster on 12/03/2021. On 12/05/2021, I developed strong stomach pain with heartburns, heart palpitations, diarrhea, shivers, cold sweat, troubled vision, headaches and dizziness.  Since I received the COVID19 booster, I have Gastroesophageal Reflux Disease without Esophagitis. I take Omeprazole daily.
After getting the anticovid vaccine on her left deltoid, individual reported sudden/chronic numbness on palms. Denies tingling.  Medic assessed.  Pt. advised to inform PCP.
07/08/2022 Vaccination 07/11/2022 Noticed from pictures, the rash appeared on her left arm and left cheek.  07/16/2022 I noticed the rash was located on left arm, cheek and leg but no where else on her body. We called the Pediatrician office. We went to see them on Monday as it was not emergent. 07/18/2022 She had more rash on her body today. The Doctor stated there may be a connection to the vaccination, potential reaction. Over the weekend we had her on Benadryl. But now switching to Zyrtec and started today. We notice when the medication is wearing off, the rash is more prominent. The recommended Xyzal if Zyrtec doesn't work. If it appears in joints or not her happy self, we could do a round of steroids.
8 days after vaccine, I developed " Covid arm" . Red, tender and swollen over deltoid with swelling extending medially to just above antecubital fossa. Pain and spasm into left trapezius. Redness lasted 3 days. Spasm about 3-4 days and swelling lasted 6 days. No other systemic symptoms . ( no fever,etc) I did get second shot 1 month later , ( in same arm )  Had mild reaction but better than first time. Very slight redness for 1 day . Tender and swollen but much less for about 3 days. Again , no fever or systemic symptoms.
within 4 hours I began to feel pain in my arm,  a severe headache and was very tired ...  that night it was worse. By the next  morning (around 10) I could barely move, ached and hurt everywhere. No appetite. Felt like the worst flu I've ever experienced. This went on throughout the night and into the next morning. By 10am on the 2nd day of feeling very sick, the symptoms began to dissipate and by 4 pm I was fine.
Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On approximately 12-FEB-2013 (reported as on or about 12-FEB-2013), the patient was vaccinated with ZOSTAVAX, (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries (prophylaxis). No other suspect or concomitant therapies were reported. On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. On 10-DEC-2016 and on 04-JAN-2017, the patient was treated for shingles and post herpetic neuralgia. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter determined adverse events as medically significant, disabling and life-threatening events.
pt recv vax 15JUL95 & 23APR97 pt devel 50-100 lesions;
scattered pinpoint erythemic macular rash that started on the chest/abd extending to the feet-began to self resolve in approx 10 minutes
Pulmonary Embolism- left lung. Eliquis 5mg tablet medication once in morning and once at night
Minutes after receiving the vaccine the patient sat down in a chair and said she was feeling weak,  minutes later she went unconscious and her limbs became very stiff. She would not arouse to voice or shaking, smelling salts were placed under her nostrils and that brought her back to consciousness. Patient sat back in the chair was very clammy and disoriented. BP was 108/72, sips of juice provided to patient.. EMS was called and arrived, BGM was 126 and BP was in the 80s. Patient was transported to ER by ambulance.
At 4:30PM on 3/7/08, patient experienced dizziness, slight confusion and "fogginess".  At 7:00PM on 3/7/08 patient related "itching and redness all over".  She took a dose of oral Benadryl that evening and was able to sleep.  On 3/12/08 itching and generalized redness is still present, concentrating at the knee area.
pt recv vax on 6/95 & on 4/98 pt was dx with (attenuated) varicella
Unilateral axillary lymphadenopathy (side of injection. Swollen and tender. Noticed when laying down for bed on left side ~1 hour ago (11:00 PM).
Vaccination 9/24/09-10:45 AM No problem initially 9/25/09 - site sore & arm stiff - Rt 9/26/09 - Rt upper arm, from above vaccination site to mid upper arm, swollen, red & warm to touch. Visit to MD-> Levoquin 500 mg OD - started 9/26/09 12:30 pm.
Patient was given the wrong dose of the covid-19 Pfizer vaccine.   Patient is 13 yrs only He should have received the covid - 19 pfizer vaccine for 12 -17 yrs old.
Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.  A 69-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and cholesterol (abnormal). Concomitant medications included blood pressure medication and cholesterol. The consumer was reporting on behalf of his 69 year old wife. She received the first dose of the BNT162B2 vaccine on 30Jan2021. On 06Feb2021, she started to experience itchiness, a rash, and a big area of redness on her left arm which was the injection arm. He stated he heard that the second dose can cause more side effects and he stated they both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. Yesterday night, last night his wife noticed that the arm where she had the vaccination it has like a rash and he knows this online that Moderna has something called COVID arm but it doesn't say anything about Pfizer. He meant it's not to bother it itches a little bit you put some anti-itch cream on it wasn't a big deal. He was kind of concerned about the next you know they got the next one coming on the 18th, so, does she should change arm, do it on the other arm. Consumer added that that would be fine, he knows you guys want to know if there was any reaction so that you can log it in and that was basically why he called. They were going for their next shot they were going to the hospital and there were professionals there so pretty much ask them what they should do. Should they change arm or nothing to worry about if they do it again that was not the problem he just wanted to let you guys know that there was some kind of reaction a rash. Consumer stated he just put Cortaid cream on it and itch went away. The patient underwent lab tests and procedures which included lab work on 27Jan2021: doctor did for cholesterol, blood pressure reasons and everything was fine. The outcome was recovered for the event itchiness; and unknown for the rest of the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170691 same reporter and drug, similar events, different patient
pt brought to ED via EMS; pt on 2L O2 via NC at home; O2 sats 85%; positive for COVID in ED; admitted; placed on NRB; given remdesivir, decadron; DNR; pt's condition worsened and she passed away in the hospital
covid vaccine breakthrough case  dose 1 Pfizer 1/16/21  EL3249 dose 2 Pfizer 2/6/21  EL9265
sharp, stabbing facial pain (rt side of face along cheekbone);extreme fatigue, tingling, heaviness & numbness (nerve pain)  bruising, tremors, electrical shocks lower back muscle, twitching, visual disturbances;muscle cramps
On the Tetanus injection site . C/o pain, swelling, knot formation and redness.
BODY ACHES; DRY COUGH; FEVER OF 98 TO 101; This spontaneous report received from a patient concerned a 47 year old male. The patient's weight was 230 pounds, and height was 70 inches. The patient's past medical history included: flu like symptoms, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known allergies. Patient had no drug abuse or illicit drug usage. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient experienced body aches. On 23-AUG-2021, the patient experienced dry cough. On 23-AUG-2021, the patient experienced fever of 98 to 101. Laboratory data included: Body temperature (NR: not provided) 98-101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, dry cough and fever of 98 to 101 was not reported. This report was non-serious.
pt recv vax; exp 2 hives;lasted few hr; felt flu like sx next day,lasted 3 days;
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear.  Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness.  Patient report cardiac hx.  + nausea and feeling ?flu like?.  Patient called off of work the night of 13th and 14th due to feeling unwell.  Patient denies fever.  At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping.  Patient denies COVID-19 exposure without proper PPE and travel.   Last day of work and shift - ? 1/12 (night shift) Home remedies? -   rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing.  Patient reports previously tested in March (negative result).  Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing.  Patient verbalized back understanding and denied further questions at this time.
Sore arm; Red; Warm to touch; Hard; Itch; Raised; Slight headache; Covid arm; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard) and PRURITUS (Itch) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since 1998, Hypothyroidism since 1999, Obstructive sleep apnea syndrome since 2019 and Open angle glaucoma since 2018. Concomitant products included DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) from 2010 to an unknown date for Dizzy, LATANOPROST (XALATAN) from 2018 to an unknown date for Glaucoma, LEVOTHYROXINE SODIUM (LEVOXYL) from 1999 to an unknown date for Hypothyroidism, DIMETHYL FUMARATE (TECFIDERA) from 1998 to an unknown date for Multiple sclerosis, TAMSULOSIN (FLOMAX) from 2014 to an unknown date for Urinary retention.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION COMPLICATION (Covid arm) and VACCINATION SITE RASH (Covid arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard), PRURITUS (Itch), RASH PAPULAR (Raised) and HEADACHE (Slight headache). On 12-Feb-2021, VACCINATION COMPLICATION (Covid arm) had resolved. On 15-Feb-2021, VACCINATION SITE RASH (Covid arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red), SKIN WARM (Warm to touch), INDURATION (Hard), PRURITUS (Itch), RASH PAPULAR (Raised) and HEADACHE (Slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up Append. new event added which is recovered and resolved
9/4/21 4:00AM mild fever 99.6F and soreness at site of injection.; treated with Ibuprofen 9/4/21 12:00PM mild fever, soreness at site of injection and swelling and tender lymph nodes in left armpit 9/5/21 3:00AM moderate fever 100.8F soreness at site of injection and swelling and tender lymph nodes in left armpit 9/5/21 5:00PM no fever, soreness at site of injection and swelling and tender lymph nodes in left armpit 9/6/21 8:00AM no fever, soreness at site of injection and swelling and tender lymph nodes in left armpit 9/7/21 7:00AM no fever, no soreness at site of injection, lymph node swelling decreasing.
OBSTRUCTIVE SLEEP APNEA HYPOTENSION 3/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
From the first dose she had body pain in the arm and slight headache; From the first dose she had body pain in the arm and slight headache; My wife was Pregnant and she received her vaccine at one week of gestation; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband). This consumer reported for a 35-year-old female Patient (Wife) that: A 35-years-old Pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 35-year-old). Patient has ongoing pregnancy. The patient's concomitant medications were not reported. The reporter stated that the patient was pregnant, and she received her first dose of vaccine at one week of gestation on 17Mar2021. The reporter also stated that on an unspecified date after first dose the patient had body pain in the arm and slight headache. The mother was 1 Weeks pregnant at the onset of the event and her last menstrual cycle was on 10March2021. The mother was due to deliver on 24Dec2021. The outcomes of the events were unknown.
Has large, pink urticaria wheals on face, neck, trunk, upper and lower extremities. No fever. Wheals are dissipating; were present beginning four days after injections. On fifth day, dissipating. Treated with Benadryl PO.
Case number PHEH2014US023487, is an initial spontaneous report received from a nurse on 21 Nov 2014, with a follow up report received from the Quality Assurance Department (QA, reference number: 340911) on 07 Jan 2015. This report refers to patient of unknown demographics. Historical condition was not reported. No concomitant medication was reported. On an unknown date, the patient was vaccinated with MENVEO (batch number: M14069) intramuscularly at a dose of 0.4 ml instead of 0.5 ml. It was reported that after MENVEO reconstitution volume of vaccine in the vial was 0.4 ml. No adverse event was reported following this administration error (vaccine underdose). Non-significant follow up report received from the QA department on 07 Jan 2015: Updated QA reference number only.
Patient describes area from acromion process to almost elbow as being so painful it was hard to raise her arm. Patient describes that pain, swelling and warmth covered at least 2/3 of her upper arm. She also redness and swelling which was warm to touch in this same area. She reported low grade fever (she did not take temperature) and feeling fatigue and achy within the first 24 hours and also c/o pain from axilla which extended to down below her ribs on the side of the vaccine. No rash or blisters.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR-2015, the unspecified patients were vaccinated with VARIVAX (lot # K007982 and expiry date: 03-JUN-2016) which was exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Flushing,  dizziness, nausea, headache, weird taste in the mouth.  muscle ache.
After receiving the first zostavax vaccine in my left deltoid,  I had redness and blisters for 7 days. Since then I have a knot in my deltoid at site of injection and still have pain in my left deltoid region.  It is sore to raise my arm and touch. I had the second one in my hip, with no problem. It's almost been one year, and my arm still hurts. In a healthcare employee so I'm not a hypochondriac.  It's just weird that it is still painful.