chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They are only 30% effective; I have been "overdosed" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; I have been "overdosed" with the PREVNAR and PNUEMOVAX shots. I am 68 and have been getting then since I was 50; Pneumonia; This spontaneous report was received from a 68-year-old patient of an unknown gender concerning to themself via Pfizer. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not provided.  On an unknown date, since the patient was 50-year-old, the patient had been getting vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) and with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) (indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). The patient was certain the she had been "overdosed" with the vaccines shots(overdose).  In January 2021 (reported as last January), she got pneumonia and went to the urgent care, where, the patient explained to the physician she was diligent with the vaccines and the physician stated that vaccines were only 30 percent effective (therapy partial responder).  The outcome of pneumonia and therapy partial responder was unknown. The causal assessment between the events and the suspect vaccines were not reported.  Upon internal review, pneumonia had been considered a medically significant event.
PATIENT SAID THE ARM HURT AFTER THE VACCINE LIKE USUAL, HOWEVER AFTER A  FEW WEEKS THE PAIN WAS WORSE. SHE SAYS IT HURTS AT NIGHT AND IT HURTS TO RAISE HER ARM. SHE DID NOT REPORT THIS UNTIL DECEMBER 15, 2022. SHE WAS VACCINATED BACK ON 10/7/22. I TOLD THE PATIENT SHE  SHOULD SEE A DOCTOR TO RULE OUT ANY ISSUE, BUT SHE SEEMS TO THINK IT IS THE VACCINE
p/vax pt devel diffuse alopecia areata;pt has currently lost most of hair in a diffuse pattern;
This case was reported by a consumer and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced chills, fever, general body pain, influenza-like symptoms and bone pain. On an unknown date, the outcome of the chills, fever, general body pain, influenza-like symptoms and bone pain were recovered/resolved. It was unknown if the reporter considered the chills, fever, general body pain, influenza-like symptoms and bone pain to be related to SHINGRIX. Additional details were provided as follows: The patient was just sharing information, and she did not want anything. The age at vaccination was not reported, the patient received the first dose of SHINGRIX and a few hours after the patient  experienced chills, fever and it ached all over, the patient felt like had the flu, the  bones ached and was okay after 12 hours. This case has been linked with case US2018GSK179197 reported by the same reporter for the same patient.
a 6 month old patient received GARDASIL 9 due to human error; This spontaneous report has been received from a physician referring to a 6 month old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On 14-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) due to human error (product administered to patient of inappropriate age).
Starting 3/21/2021 Pain, right knee, thumb swelled, terrible joint pain, muscle pain, tendon pains in legs and arms, knee is still swollen. Severe fatigue. In physical therapy
A nurse reported that a female received an injection of Prevnar on 02/14/2002 and a few hours following immunization, developed bruising at the injection site. Later that day, the pt developed petechia on her face. As of the date of this report, no further info was available.
65 y/o medical transcriptionist presents with h/o pain left upper extremity (LUE) since receipt of influenza vaccine at Flu Drive on 01OCT12. Since then, she c/o a dull, persistent ache in deltoid muscle which has limited her range of motion and ability to raise her left arm laterally above her left shoulder.
A non-serious, spontaneous report of congestion has been received from a patient's mother concerning her ten-year-old child subsequent to FLUMIST. The patient's medical history was not reported. The patient received FLUMIST on an unspecified date. On 21-Sep-2009, the patient developed congestion. The event resolved the same day.
Patient reports pain at injection site and tight muscle since 7/25/09. No redness, no warmth, no swelling. Patient advised to return to clinic or see PCP.
Pt is a 69 y.o. female with past medical history of lupus, mixed connective tissue disorder, chronic immunosuppression on Plaquenil, methotrexate, and Rituxan, interstitial fibrosis likely secondary to autoimmune disease, prior smoking history, who presents to the ER with complaints of shortness of breath, cough, and loss of taste and smell.   Patient reports that she has felt ill with bronchitis-like symptoms since October. She reports that she has not had any resolution in her symptoms since that time despite seeing multiple nurse practitioners outpatient and treatment for bronchitis. She states that 3 days prior to admission she began to lose her taste and smell. She reports fever as high as 102. Oxygen saturation as low as 87% on room air upon presentation in the ER tonight. She tested positive for COVID-19 on 12/2/2021.   Reports occasional dry heaving associated with coughing. Reports worsening shortness of breath prompting her visit to the ER tonight. She reports significant bronchospasm after coughing episodes despite antitussives at home. Reports chills. Denies any nausea but does report decreased appetite. No diarrhea. Husband also tested positive over the past few days.   Patient is fully vaccinated and boosted for COVID-19.
took the shot and within a year I has the worst case of shingles/Suspected Vaccination failure; worst case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the shot and within the year, the patient had the worst case of shingles. The patient's physician had ever seen and just the luck of the patient. The patient took the shot by all the means and mentioned that be aware vaccine might not work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
On 8/3/2022, I started to have a cough and a headache in the afternoon. On 8/4/2022 I had a fever of 101.5. I had a sore throat, nauseous, headache, cough. I had all the symptoms. I took a COVID-19 home test on 8/4/2022 and the results were positive.  I called my doctor, and she prescribed the Paxlovid on 8/4/2022. On 8/11/2022 - PCR COVID-19 test- positive. I felt better after 5 or 6 days. I took a home test and it was negative between 8/11 and 8/18/2022.   On 8/18/2022, I started with a cough again. Then on 8/19/2022, I took a home test and it was positive again for like 5 more days.
Tingling around right eye in temporal area and cheek bone.  Also across forehead.  Sore to touch.  1 pimple.  Tingling increasing to face and top of head by 9/5/14 and possibly around body.
Loss of smell; Cough; Difficult to talk; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk) 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.   In January 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 ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk). At the time of the report, ANOSMIA (Loss of smell), COUGH (Cough) and SPEECH DISORDER (Difficult to talk) outcome was unknown.            Doctor stated that the these symptoms recur every month.  Concomitant medication was not provided.  Treatment information was not provided.
immediately after vaccine experienced throat tingling,tongue felt swollen,flushed face. approximately a week later had swollen lymph nodes of neck, upper chest and soreness,of the lymph nodes at that time Winthrop Pediatrics was notified, and recommendations for ibuprofen were given.Then a few days  later I had mouth sores, my throat was still thick feeling and sore, and still had swollen lymph nodes. These symptoms were reported by my mother to Winthrop Pediatrics. I was instructed to rinse with salt and water for the sore throat. At this date I am still experiencing swollen lymph nodes but less swollen, other symptoms are gone.
stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division.  An adult female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 04Mar2021, outcome "unknown", described as "stroke". Clinical course: On or about (date) 03Mar2021, 09Sep2021 plaintiff was injured by the following product. On 03Mar2021, Decedent (Name withheld) received a dose of Defendants Pfizer/Pharmacia SARS-Covid2 for protection Covid-19 and (Name withheld) had multiple strokes thereafter. First, on 04Mar2021 just a day after the 03Mar2021 vaccine; then (Name withheld) received another dose on 09Sep2021 (also reported as 09Sep2020) and she had more strokes shortly after in Sept, Oct and Nov2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
please note product was the FLUZONE HIGHDOSE QUAD 20- 21 PF - unable to select that product above.  NauseaVomiting and weakness
Sudden sensorineural hearing loss that developed over the course of 3 days. Severe to profound hearing loss in left ear. Responded well to intratympanic dexamethasone and oral steroids. Hearing fully recovered within 2 weeks.
Fever (tympanic) to 104.7 on 3/4/13 with chills, reported by parents to be "shaking, eyes almost rolling" but awake and alert during event. Found to have white patches or erythematous tonsils but otherwise unremarkable exam. Vigorous and well appearing and playful in no acute distress. Had one loose bowel movement.
About 12 hours after receiving the shot, my wife woke up to severe chills and shaking (with teeth chattering).  She advised that she couldn't even pick up and put on her glasses.  She woke me and I was able to provide her a heating pad that over about 15 minutes reduced the shivering and chills. Her face was so pale that her freckles literally disappeared.  I was ready to call 9-1-1, but she asked me not to (because they would not have let me go with her).  So, I monitored her and gave her two Tylenols.  For the ensuing 24 hours, she ran a 100-degree fever, had slight chills, and took Tylenol tablets periodcially.
Child developed secondary cellulitis at the Kinrix injection site in her left thigh. MMRV injection site in the right thigh did not demonstrate any adverse event. The left thigh rash began with a pustule within the first 24 hours following Kinrix immunization and then progressed to surrounding induration over a 2 day period. She was diagnosed with cellulitis on a follow-up visit on 05/19/2020 and prescribed empiric cephalexin for treatment.
Received Rubella vaccine 5Apr90, On 17Apr90 developed generalized rash, malaise, sorethroat & cough, Recoverd 23Apr90
Patient felt dizzy a few seconds after getting the immunization. Stood up and after a few steps sat down. According to Father she had a possible seizure: was shaking her head back and forth few times and then she had her tongue sticked out and then 911 was called.
Red spot 40 x 90mm, elevated, warm to touch. Treated with aspirin & BENADRYL generic.
The patient developed on April  9th severe shoulder pain. Then on  April 13th, 2021  neurogenic bowel and neurogenic bladder, presenting with constipation and urinary retention issues. Later he developed Facial weakness, paresthesias of upper and lower extremities, difficulty with ambulation, feeding, drinking, finally he lost all movement in his lower and upper extremities and became bed bound. He was diagnosed with  Miller Fisher Sd, and then Guillain Barre Syndrome, requiring multiple ER visist,  hospital stays after the vaccination,. currently he is hospitalized at Hospital. Still he is bedridden. Cannot ambulate, cannot move his legs and cannot move well his upper arms.
I know that I'm on medication for my heart and those can cause hair loss. This hair loss is the top/crown of my head. It's very thin and I've been on my medications for years and I've never had this. In August 2022, I had COVID-19. Then I recently had the Pfizer bivalent vaccine (previous doses were Moderna) and my hair was coming out in brushfuls. With my hip, it felt like my leg was going to fall out of the socket. I went to an orthopedic and they did an x-ray and an MRI for my hip. I had a partial tear in my hamstring and I had to go to physical therapy for 4 weeks, twice weekly which I have just finished. That pain in my hip started in October, and it got worse in December after the vaccination. I do have a vitamin D deficiency, but the doctor said to go get it checked out. The physical therapy has helped and I've been put on calcium and vitamin D. I'm also hoping that my hair will regrow, but I don't know. I went on vitamin D which can maybe cause hair loss too, but I think it may be more related to having had COVID-19 or the vaccination. I was also given the PAXLOVID back in August, but I got a rebound case. I had COVID-19 for about 20 days. My doctor has reduced my metoprolol and has put me on amlodipine recently.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via agency (Reference number- 00517090) and transmitted to Sanofi on 12-Mar-2021.  This case involves a 10-month-old male patient who received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ182AAA and expiry date: 08-Mar-2021) via an unknown route in left thigh for prophylactic vaccination on 12-Mar-2021.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE on 12-Mar-2021 for prophylactic vaccination.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
10 days after injection developed large hive at injection site Approx 3in x 2 in. Itchy hot took Benadryl 25mg Pepcid 20mg still had red hive next day slowly going away
Swelling of the face and throat.  Difficulty swallowing, some difficulty breathing, got hot - like a hot flash, rash on the face,  Fast heartbeat.  Symptoms resolved after about 30 min to an hour.
Extremely painful injection site beginning about 8 hours after injection.   Starting 30 hours after: Fever 101.5, Chills, Muscle pain, joint pain, general malaise.    Starting 72 hours after,  red area, warm to the touch about 2.5 inches diameter  at injection site.
Within 24 hours of shot, experienced right facial numbness and decrease in facial tone. These symptoms disappeared within 24 hours. 2 days after shot, right side facial twitching  occurred and then 3rd day the twitching  went away.  01/08, noticed mild weakness in grip strength of right hand and tingling in right big toe. 01/10/2021,  difficulty holding a pencil and numbness in pinky finger and right ring finger, also partial numbness in toes, of right foot as well slight reduction in right leg strength
The day after receiving my second dose, the lymph node in my right underarm swelled up and was painful. Now on day 4 of this reaction, it has grown bigger and the pain is intense and spread all the way down my arm and to my breasts. My arm will go numb from time to time as well. I am also feeling as if I should have a fever but I do not and feel overall not well.
EGFR was low; Sodium is high; high in calcium; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 04Oct2023 as dose number unknown, single (Lot number: 370271) for immunisation. The patient's relevant medical history included: "cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GLOMERULAR FILTRATION RATE DECREASED (non-serious) with onset 04Oct2023, outcome "unknown", described as "EGFR was low"; BLOOD SODIUM INCREASED (non-serious) with onset 04Oct2023, outcome "unknown", described as "Sodium is high"; BLOOD CALCIUM INCREASED (non-serious) with onset 04Oct2023, outcome "unknown", described as "high in calcium"; DIZZINESS (non-serious) with onset Oct2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, glomerular filtration rate decreased, blood sodium increased, blood calcium increased.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The batch number for SHINGRIX was not reported. The healthcare professional stated that the patient developed rash above her lips after a dose of SHINGRIX. The patient went to her doctor and was treated in an outpatient clinic. The healthcare professional did not have any vaccine information at the time of reporting and did not want to provide the patient's date of birth.
hot flashes; dizziness; feels pressure on chest when she lays down at night; tiredness; chills (on & off throughout the day); achy bones; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (achy bones), HOT FLUSH (hot flashes), DIZZINESS (dizziness), CHEST DISCOMFORT (feels pressure on chest when she lays down at night) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MoD011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sinus pain. Concurrent medical conditions included Allergy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced BONE PAIN (achy bones) and HEADACHE (Headache). On an unknown date, the patient experienced HOT FLUSH (hot flashes), DIZZINESS (dizziness), CHEST DISCOMFORT (feels pressure on chest when she lays down at night), FATIGUE (tiredness) and CHILLS (chills (on & off throughout the day)). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BONE PAIN (achy bones), HOT FLUSH (hot flashes), DIZZINESS (dizziness), CHEST DISCOMFORT (feels pressure on chest when she lays down at night), HEADACHE (Headache), FATIGUE (tiredness) and CHILLS (chills (on & off throughout the day)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
This spontaneous report as received from a physician assistant refers to an unspecified number of patients of unknown age and gender. No historical conditions, concurrent conditions or concomitant medications were reported for these patients. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot #, expiration dates, dose and route of administration were not provided) for prophylaxis. PEDVAXHIB was exposed to 33 degrees F for 23 minutes. The excursion was captured via a Digital Data Logger. There was no previous temperature excursion. There was no adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000922.
I have COVID infection Sept 30, 2020. I was still having residual body aches and pain from that infection. After getting the vaccine, I had flu like symptoms and COVID like symptoms- body aches, fatigue, brain fog and chills. These symptoms started to resolve after 2  days and slowly went away. However,  I am still having lingering body aches and muscle pain that have worsen over time. I did go see my doctor and he recommended herbal and over the counter supplements. I did tried herbal medications ginger, turmeric, magnesium, ibuprofen, which has not helped. I have a chronic sharp pain in my back and legs which has not gone away.
Information has been received from an 89 year old female patient with arthritis who was vaccinated with ZOSTAVAX (Merck) one year ago approximately in July 2008. Concomitant therapy included CELEBREX. 6 months ago on approximately 06-JAN-2009 the patient developed a full blown shingles, her left butt was covered with shingles and it got up to vagina. The patient was bed ridden for 2 months because of the pain and she couldn't sit. She was healthy until she got the shingles. The patient had sought physician for medical attention and had not recovered. The patient's bed ridden for 2 months was considered to be disabling. No further information is available.