chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menveo only liquid portion administered; Menveo only liquid portion administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 41-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA762A) for prophylaxis.   On 19-JUL-2023, the patient received Menveo. On 19-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion administered) and inappropriate preparation of medication (Verbatim: Menveo only liquid portion administered). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date 19 Jul 2023 The nurse reported only the liquid portion of Menveo was administered to a patient. The reporter consented to follow up.  Patients initial asked and declined. The nurse reported only the liquid portion of Menveo was administered to a patient, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently, the patient developed a rash after receiving a dose of Gardasil. As of 13-JUL-2007, the outcome of the patient's rash was unknown. Additional information has been requested.
7/31/21 tested positive for COVID.  fever, cough, bodyaches, diarrhea, loss of taste and smell
experiencing swelling of the arm underneath the area where the flu shot was given, arm pain, warmth for 2 days, not getting any better
Flu like symptoms; Fever; Body aches; This is a spontaneous report from a contactable consumer (patient). Via medical information team reported that:  A 52 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 28Mar2021 (at the age of 52 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that not related to a study or programme. No other Products, investigation Assessment, emergency Room and Physician office. On an unspecified date, the patient experienced flu like symptoms, fever, body aches. The outcome of the events was recovered.  Follow up#1(PRD10May2021): This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that:  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 12FEB97 & 13FEB97 ran temp-t99 until 5AM;spiked to 104.5;mom bathed cool water called ER:recommended APAP for fever;15FEB97 t102+;
pt recv vax 19DEC96 rt deltoid Sc;2DEC96 noted approx 14-16cm redden area on rt deltoid;no tx was done;area monitor 22DEC96 faded;
Sick of 5 days; Nauseous; Unstable with balance; very tired; This is a spontaneous report from a contactable consumer (patient). A 76-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on 27Jan2021 (at the age of 76-year-old), at single dose, for COVID-19 immunization. Medical history included high blood pressure (taking high blood pressure medication for years, i take 2 blood pressure medicines, take that one in the morning and one in the night); asthma; and glucose tolerance impaired (pre-diabetic). Concomitant medications included amlodipine for hypertension; candesartan for hypertension; cetirizine hydrochloride (ZYRTEC) for asthma; colecalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12); and vitamin B complex (B Complex). The first shot patient was sick for about 5 days, very nauseated, very unstable with balance and very tired. Patient's weight was about 147 pounds. Patient stated first one didn't give patient asthma. Patient stated had pneumonia, shingle shot (unspecified shot) and flu shot. The patient underwent lab tests and procedures, which included sodium was low; and CBC (full blood count) was 4-5. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe vertigo after injection I called adverse event to report event in 04/28/99. I saw an ENT specialist and a neurologist. I was given "antivert" as a medication.
The second day after the vaccine . My arm became red, swollen pain and very warm. Blisters broke out and now burned areas.
I went in to get my 1st pfizer shot, and my right hand started tingling within five minutes of receiving the vaccination in my right arm. I sat in the waiting room for fifteen minutes and friends told me they had slight tingling that didn't last very long so I left. I took a nap the tingling got worse throughout the day, I ended up in the ER that night of 10/2/21 when the pain started to set in I had numbness in my shins and feet and tingling in my hands and numbness in my hands. They treated me with an IV drip, did tests drew blood, gave me a potassium pill and a rapid covid test which came back negative. They acknowledged this was from the Pfizer shot. I was released then I came back in to the ER that next morning of 10/3/21 as the pain got worse and they told me to come back in if it indeed got worse. They treated me with steroids as my throat was starting to close up, and the tingling and numbness got worse. It felt like someone was grabbinig me hard around my wrists and knees as well. They released me and diagnosed me with Parasthesia.
About 15 minutes after vaccination I started feeling nauseous and around 7:00pm I started getting a headache. During the night I had an upset stomach. Next morning I couldn?t get out bed I have body aches, headache, dizziness, nausea with no appetite.
Red rash (on trunk only) noticed 9/16/03 6:00 PM. Fussy; afebrile. Parent phoned family physician, who told parent rash was probably a mild reaction to an immunization. Rash gone by 9/18/03 at 5:00 PM.
Extreme behavioral changes for several weeks followed by gradual loss of all motor, cognitive and behavioral skills.  Advanced 2 year old with extensive vocabulary and well developed social skills eventually lost all speech, ability to walk or crawl, etc.  After 20+ days in multiple hospitals she was diagnosed with anti-NMDA receptor encephalitis.  She is still in hospital getting treatments ans aggressive rehabilitation. Continues to have extreme behavior and lacks motor and cognitive skills.  Has had treatments of IVIG, steroids and Rituxan.  Will continue to receive all 3 once a month for six months or more while continuing rehab to regain skills.
Started having headaches within a couple days after second Pfizer COVID-19 dose along with tinnitus sometime that week.  Subsequently diagnosed with hypertension consistent 150/110 (was normal 120/80 at last measure 6 months prior).  Blood pressure has been controlled with amlodipine 5 mg qd but tinnitus has not resolved
received Shingrix rather than the COVID vaccine; 8 year old mistakenly received Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 8-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th December 2021, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient mistakenly received Shingrix rather than the intended COVID vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
PAIN IN ARM AROUND AND BELOW INJECTION SITE WITHOUT RELIEF AFTER TAKING TYLENOL
Injection Site Pain, Severe, 12/27-12/28, Self-Resolved Chills, 12/27-12/28, mild, Self-Resolved Headaches, 12/27-12/28, Severe, Self-Resolved Malaise, 12/27-12/28, Moderate, Self-Resolved Myalgias, 12/27-12/29, Moderate, Self-Resolved Arthralgias, 12/27-12/28, Moderate, Self-Resolved Lymphadenopathy, 12/27-12/28, Mild, Self-Resolved
Pt recieved vaccineslisted above on 04/26/2022.  He presented to the clinic 05/02/2022.  His vaccine sites on his thighs are indurated , itching, and erythematous.
Local reaction - redness, swelling and warmth to deltoid - did receive flu shot in the same arm at the same time due to pt's preference.
Itching, redness, bumps around injection site starting 5 days after 2nd dose
Patient presented to the pharmacy today with a small rash around the injection site. Per patient report the rash appeared "redder and more itchy" this morning. No reports of trouble breathing or other notable symptoms. Patient had not yet tried an antihistamine or a cold compress. Recommended she starts both of these options today. Also recommended the patient goes in to see a doctor if the rash spreads further or becomes more irritated. The patient is going to keep an eye on the rash and will go in to see a doctor if the rash is not resolved within the next day after trying an antihistamine and cold compress.
The pt was given Prevnar Vaccine (10/22/04) and assistant thought she was giving pneumococcal vaccine. The lot # indicated Prevnar was given. Pt called the office 10/25/04 complaining the arm where she was given the pneumococcal vaccine was red, hot and swollen and the symptoms worsened over the weekend. She was seen by Dr 10/25/04 and advised at length. She was given NSAIDS and Omnicef 300mg x 6 days
Shortness of Breath; Fluid retention; Gradual swelling on legs and thigh; Legs and thighs itching; Legs and thighs peeling; Legs and thighs very red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and FLUID RETENTION (Fluid retention) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath) (seriousness criterion hospitalization) and FLUID RETENTION (Fluid retention) (seriousness criterion hospitalization). In April 2021, the patient experienced PERIPHERAL SWELLING (Gradual swelling on legs and thigh), PRURITUS (Legs and thighs itching), SKIN EXFOLIATION (Legs and thighs peeling) and ERYTHEMA (Legs and thighs very red). The patient was hospitalized on 30-Mar-2021 due to DYSPNOEA and FLUID RETENTION. At the time of the report, DYSPNOEA (Shortness of Breath) and FLUID RETENTION (Fluid retention) outcome was unknown and PERIPHERAL SWELLING (Gradual swelling on legs and thigh), PRURITUS (Legs and thighs itching), SKIN EXFOLIATION (Legs and thighs peeling) and ERYTHEMA (Legs and thighs very red) had resolved.            No concomitant medication details were reported. On 29-Mar-2021 patient had a surgery and the day after surgery, had shortness of breath and fluid retention and went to hospital for 2 days for that incident. Two weeks after surgery, patient got gradual swelling on legs and thighs which were itching and peeling and very red. Treatment included antibiotics and after 3 weeks of antibiotics, the swelling, itching and peeling went away.  Company comment: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea and Fluid retention. The events occurred approximately 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), and 2 days after an unspecified surgery. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine)  is not affected by this report.; Sender's Comments: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dyspnea and Fluid retention. The events occurred approximately 8 days after the second dose of mRNA-1273 (Moderna Covid-19 vaccine), and 2 days after an unspecified surgery. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine)  is not affected by this report.
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 03-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003823; US-009507513-1804USA003824; US-009507513-1804USA003769.
Pt. developed cellulitis of (R) thigh where shots given. Failed outpatient oral antibiotic therapy, hospitalized x 2 days for IV antibiotics, then sent home on different oral antibiotic. Cellulitis resolved.
area became sore & red raised area around the inj site;seen in office 16JUN95;area became larger & tender to the touch w/red raised area on lt arm but 2-2 1/2 on lt arm about 2-2 1/2 in diameter;no fever;tx w/dimetapp;
Patient was here to receive 2nd dose Moderna, but Pfizer was administered by accident.  Patient was informed and new card given.  No adverse effects
Bells palsy- pain and pressure on rear left side of head and ear. Numbness on the left side of face ,jaw and tongue. Left eye does not blink so constantly tears, slurred speach and  no taste. Symptoms started on 3/21/21 and got worse. Meds prescribed acyclovir 800mgs , prednisone 10mg and Diclofenac sod dr 75 mg for pain.
Severe site reaction, swelling, itching, muscle aches, itching, nausea, headache, abdominal pain.  Moderate diarrhea, mild fever
The patient described feeling tired and "not quite himself"; The patient described feeling tired and "not quite himself"; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (The patient described feeling tired and "not quite himself") and FATIGUE (The patient described feeling tired and "not quite himself") in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and CELECOXIB (CELEBREX) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced FEELING ABNORMAL (The patient described feeling tired and "not quite himself") and FATIGUE (The patient described feeling tired and "not quite himself"). On 12-Mar-2021, FEELING ABNORMAL (The patient described feeling tired and "not quite himself") and FATIGUE (The patient described feeling tired and "not quite himself") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant follow up appended
This spontaneous case reported by a consumer, describes the occurrence of pain (body ache) and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain (body ache) and fatigue. At the time of the report, pain (body ache) and fatigue outcome: unknown. No concomitant medication or treatment information provided.
I had headache after 4-5 hr of injection and sore arm until next day. After that I was not having symptoms but one week later I got a late reaction at the site of injection. It is swollen red hard and itchy and inflamed. So I went to Dr. and she has suggested me to take Motrin and use cold ice pack. So I took a Motrin yesterday and today. I had a reaction where I had BCG vaccination in the childhood.
Case number PHEH2013US018759 is an initial spontaneous report received from a pharmacist on 04 Sep 2013. This report refers to multiple patients whose identifiers were not reported. The patients' medical history and concomitant medications were not reported. These patients were vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on unknown dates (the vaccine was of 2013/2014 season). It was reported that these patients were administered the vaccine which was pre-drawn in syringes from multi dose vials. No adverse event was reported following the inadvertent administration.
Extreme limb swelling, hot skin, redness, mobility impaired in affected limb.
1:30 pm mom stated she brought baby in on 1/28/04 to get DTaP #4 and HBV/Hib. Symptoms after shots, child had 104 degrees Ax temp at 3 am. Mom stated baby seemed lethargic, tugging on collar, trembling and grasping hands accompanied with vomiting. Children's Advil given per mom.  advised mom to have child take some syrup from fruit can in 1 hour and call back to see if child improves. Mom stated she gave child Pedialyte 1/2 hour ago. Public health nurse called mom on 2-4-04 and stated symptoms resolved on Fri 11/30, but returned on Sat 1/31/04. Mom stated over the weekend child was walking on tip toes and fever returned 102.7 (F). Public health nurse referred mom to call doctor today and make an appt. Mom receptive.
Tinnitus in right ear, constant since 4-10-2021 in the afternoon.
After receiving both doses of the Pfizer BioNTech vaccine I have experienced cramping, fatigue, headaches, lower back pain, nausea and breast tenderness. It started about 3/4 days after receiving each dose. First dose was 10/28/2021 second dose 11/18/2021. I have the mirena iud inserted for about a year now. I have trouble with endometriosis. With the first vaccine I thought it was my menstrual cycle however the same exact thing happened with the second dose. (It is not my time of the month). I have contacted my gynecologist as well as my pcp.
Right arm swollen from injection site down to elbow. Treated with ice, Benadryl and elevated.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided   No concomitant and treatment details were provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-089519 (Patient Link).
Less than 48 hours after flu vaccine I began to experience shoulder pain and limited range of motion that gradually worsened over the course of 2-3 weeks.  Simple tasks that required me to lift my arm up, such as getting dressed and combing my hair became very difficult and painful.  I have also had difficulty sleeping due to shoulder pain at night.  My family doctor diagnosed me with subacromial bursitis caused by improper administration of the flu vaccine.  He explained that the vaccine was administered too high on my arm and entered the joint rather than my deltoid muscle.  At present my family doctor has prescribed Voltaren cream to reduce inflammation and pain.  As of today, 10/15/2020, symptoms have not yet subsided and treatment with Voltaren continues.
PT here for 1st dose of Pfizer. Reported she has extensive history of nausea/vomiting after all injections, PT to be vaccinated in private room with cot. PT was made comfortable laying down on cot and given reassurance before vaccination. PT verbalized a high level of anxiety, slightly improved with psychosocial support and education, husband present. Cold pack, water, provided before injection. Vaccine administered at 1626, PT had onset of nausea, retching at 1637. VS at 1644: BP (sitting) 114/80, HR 67, RR 18, SPO2 100% RA. PT denied dizziness/lightheadedness, reported that her only problem was nausea. PT accepted small amount of water without difficulty, used cold pack on back of neck. Nausea/retching resolved quickly. At 1645, PT reported that she felt ?100% better?. PT sat in chair at 1649, transferring without difficulty. PT exited facility at 1700 with husband.
**39 weeks pregnant. , Due date 2/14/21** The second day I had a sore arm,  around mid/late morning I developed a headache that got worse. And I became nausea ( I had no nausea during my pregnancy)  , I needed up signing of  work at 1pm and rested the rest of the afternoon.  Woke up the next morning and felt better besides sore arm  .
onset 13OCT98 nausea, everyday since;onset 25OCT98 hives, both legs & arms;itching cont;
On the monday following  my vaccination is very suddenly developed SEVERE chills.  It took me three hours in a bed with electric blankets to get warm.  Headache and body aches and tiredness.  That day was the worst.   And here is is 4 days later and I am still not out of the woods.  I am still taking tylenol and advil for the body aches and chills and I have no energy
with receipt of 3rd (booster) covid vaccination; This case is considered invalid as there are no indication that patient experienced an event under the suspect drug (bnt162b2).  This is a spontaneous report from a contactable Nurse. A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 58-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 and dose 2 via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient experienced receipt of 3rd (booster) covid vaccination on an unspecified date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up on 22Oct2021 this follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.  This follow-up report is being submitted to amend previously reported information reassessed the case as invalid.
symptoms include nausea, vomiting and diarrhea. Hospitalized and admitted to ICU on 5/14/2022.