chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with prednisone allergy and hypertension. On 05-AUG-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # J002242, expiration 21-MAY-2014), 19400 PFU, subcutaneously. Concomitant therapies included CATAPRES and BENECARDIN. On 14-AUG-2013, the patient experienced an itchy, red, rash on the side of her face, and around the eye, which went down the patient's neck. The patient sought medical attention via visit to pharmacy. Patient had not yet seen physician and no treatment had been given at this time No lab diagnostic studies performed. At the time of report, the event outcome was reported as not recovered. VZVIP packet faxed to pharmacist. Additional information has been requested.
joint pain by the knee, then spread to the whole body, feels like all her joints are inflamed and she is not able to move them.
A  circle welt appeared at the injection site about 2-3 inches in diameter. It is severely itchy. There is a painful bump near the clavicle as well but it is a lot smaller in comparison.
Patient has vasovagal episode, sweating, nausea, dizziness. No loss of consciousness or syncope.
GAVE CLIENT THE 2 VACCINES AND SHE TOERATED THEM WELL. CLIENT AND HER MOTHER WENT TO  THE FRONT ADMISSION DESK AND MAKE FOLLOWUP APPT FOR SECOND HPV. CLIENT STARTED TO GET LIGHT HEADED, VERY PALE AND DIZZY. BP WAS 120/60. PUT COOL WATER COMPRESSES ON HER FOREHEAD AND BACK OF NECK. GAVE WATER TO DRINK. SHE DIDN'T EAT MUCH FOR BREAKFAST. SHE STARTED TO FEEL BETTER AND WENT HOME WITH MOHTER. TOLD CLIENT WHEN SHE GETS SHOTS TO EAT MORE FOR BREAKFAXT.
No adverse event; Bivalent doses administered after the BUD to the patient 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to the patient 12 and up).    Concomitant medication was not reported.  Patient ID was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, in this report the patient was not Eligible. Breakdown of doses were reported as 51 doses from batch numberAS7140C and 60 doses from Batch number AS7148B.  Treatment medication was not reported.
RASH ON UPPER BODY; This case was reported by a nurse via sales rep and described the occurrence of rash in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2020, the patient received Shingrix. On 17th December 2020, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient visited emergency room with rash on upper body. The patient was seen on 12th January 2021 but still she was with rash. The reporter consented to follow up.
No adverse effects; One expired dose of VAQTA was inadvertently administered to a patient on 9/9/2019; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 09-SEP-2019, one expired dose of hepatitis a vaccine, inactivated (VAQTA) was inadvertently vaccinated to a patient (expired product administered) 0.5 milliliter, for prophylaxis (lot # R021233 has been verified to be a valid lot number for hepatitis a vaccine, inactivated; expiration date reported and establish as 05-SEP-2019) (strength and route of administration were not reported).       No adverse effects reported.
physician ordered pneumococcal  23 patient was due for Pneumococcal 20.
This ae was reported to field employee. The primary reporter is Administrator. Administrator reports on an unspecified date an unspecified 27 year old patient was administered a dose of GARDASIL 9 (unknown lot/exp). No adverse effects. No additional information. This spontaneous report as received from an administrator refers to a 27-year-old patient. The patient's medical history was not reported. On an unknown date, a dose of GARDASIL 9 (lot #, expiration date, dose, route and site of administration were not reported) was administered to the 27-year-old patient for prophylaxis No adverse effects were reported.
Erythemic, hot zone around injection sites. Also pain and fever. Fever seems abated for now. The zone is 11 cm x 9 cm x mild elevation. It is not fluctulent. Placed on KEFLEX and MOTRIN. Has follow-up.
I received my first shot at 4:15PM on Sunday 04/25/21. The dose was administered into my right arm. Within 30sec-1min I started feeling pressure wave slowly spreading from my right arm and traveling to my right shoulder blade and neck. Within few minutes I developed neck pain like I pulled a muscle on my right side. 1-2min later I started having muted hearing in my right ear and felt heaviness on my head. within 10-20mins my left ear was impacted as well. (hearing issues lasted about 30mins-1hr). Also, within first 10-15 minutes my face felt swollen and heavy, but it was not visually swollen. Once I took my mask off in the car, I had red/pink marbled rash on my skin on the area that the mask was covering. I haven't had any face rash from this mask before.  I asked the vaccine site staff if the back and neck symptoms are normal, she gave me a blank stare and nodded her head. Additionally, after first 10 minutes my left thigh muscle started cramping and involuntarily moving for a few minutes, quickly followed by feeling of pulling nerve in my right thigh. That lasted around a minute and suddenly moved upwards and hit my back with sharp pain like radiculitis. Every slight change of move felt like sharp sting. I was still in the recovery area, but I had trouble staying in the sitting position. We went home and back pain developed into crippling pain within 30 mins-1hr after the shot. I could do less and less. By 1 hr I was only able to lay flat in my bed, unable to sit. Bending over would not be possible because of tightness and sharp pain. I spent the next day in bed and barely tiptoed to the bathroom when needed, holding onto the furniture and walls. It has been more than 48 hours and I still can't bend or wash my hands. I can wash one at a time. Today I can sit, so my back improved since yesterday, but my moves are limited and I feel some pain in my back when I walk. I can't sit for too long and sitting down or getting up hurts.
Information has been received from a physician who was not the administering physician concerning a 14 year old female patient who on 04-APR-2008 was vaccinated with the first dose of GARDASIL (Lot# 659982/1740U, expiration unspecified) and a dose of Tdap (manufacturer unknown). On 11-JUN-2008 the patient was vaccinated with the second dose of GARDASIL (Lot# 650553/0070X, expiration date unspecified) and a dose of MENACTRA (manufacturer unspecified). The physician reported that the patient was seen in the office in December 2008 and was taking ZOLOFT (manufacturer unspecified) at the time. Now the patient came into the office to day on 21-JUN-2010 and the mother of the patient stated that the patient would not received the third dose of GARDASIL since she was diagnosed with depression and polyarthralgia. The physician reported that the patient was now taking WELLBUTRIN (manufacturer unspecified), CYMBALTA (manufacturer unspecified) and NEURONTIN (manufacturer unspecified). The physician reported that the patient was not on ZOLOFT any longer and he did not believe GARDASIL caused the patient to have depression. At the time of report the patient's status was unknown. Additional information has been received from the physician indicated that the patient received GARDASIL vaccinations in his office. In December 2008 the patient complained of joint pain. The physician stated that the patient was referred to a psychiatrist for depression. The patient was being treated for her depression with WELLBUTRIN and CYMBALTA therapies and was on therapy with NEURONTIN for polyarthralgia. The physician stated that the psychiatrist has prescribed the medication. The physician stated the patient's depression and polyarthralgia was controlled while on the prescribed medications. The physician stated that another physician in his practice was the patient's physician. Additional information has been requested.
Lymph node swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling) and PAIN IN EXTREMITY (sore arm) in a 75-year-old male patient 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 LYMPHADENOPATHY (Lymph node swelling) and PAIN IN EXTREMITY (sore arm). At the time of the report, LYMPHADENOPATHY (Lymph node swelling) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Pt received first dose pfizer covid vaccine. Approx 1-3 min later pt lost consciousness and experienced upper extremity myoclonic jerks for approx 5-7 seconds before regaining consciousness with fists clenched. Upon regaining consciousness, pt was A&Ox4, reported slight lightheadedness; denied CP, SOB, or cutaneous sx suggestive of anaphylaxis. Pt denies anything like this in the past, denies family hx of seizures, and denies needle phobia. Pt instructed to recline supine in car seat with legs elevated on dashboard, and soon reported feeling better, less lightheadedness.
FEVER; FELT NAUSEATED; FELT REALLY HOT; COLD; COUGH; BILATERAL EAR ACHE; FELT BURNING PAIN ON STOMACH MOSTLY ON THE MIDDLE AREA; SEVERE HEADACHE; BODY ACHE; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood clot, non alcoholic, occasional smoker, penicillin allergy, allergic to amoxicillin, and bee sting allergy, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. Patient's concomitant medication included: cemoxazine100 mg twice a day for anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. Concomitant medications included hydroxyzine for anxiety. On 02-JUL-2021, the subject experienced body ache. On 02-JUL-2021, the subject experienced cold. On 02-JUL-2021, the subject experienced cough. On 02-JUL-2021, the subject experienced bilateral ear ache. On 02-JUL-2021, the subject experienced felt burning pain on stomach mostly on the middle area. On 02-JUL-2021, the subject experienced severe headache. On 03-JUL-2021, the subject experienced felt really hot. On 03-JUL-2021, the subject experienced felt nauseated. On an unspecified date, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) Headache, Body ache and Bilateral ear ache had pain scale of 10/10. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, body ache, felt really hot, cold, cough, bilateral ear ache, felt burning pain on stomach mostly on the middle area, and felt nauseated, and the outcome of fever was not reported. This report was non-serious.
Inadvertently administered Pfizer as a second dose to client whose first does was Moderna.  I was looking up all vaccines in  the computer prior to administering and I was looking at her husband's information when I though I was looking at hers.  I entered the vaccine in the computer and saw her first dose was Moderna.  I did tell the client of the issue and she expressed no concern and was insistent as was her husband she had received Pfizer for her first dose.  She said she would email a copy of her card upon her return home - email showed Moderna as first dose.
1st dose on 2018, 2nd dose in 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number DJ3FL, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in 2021, later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Approximately 4 days after first vaccine I began to develop lymphadenopathy in my right arm.  Symptoms are still ongoing 7 days after they began.
Macular rash and tender palpable purpura suggestive of vasculitis, arthralgias, fatigue. Treated with benadryl without improvement. Prednisone added 7/16/2023.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concomitant therapies, medical histories and drug reactions or allergies provided. On unknown dates, from 01-FEB-2017 to 28-FEB-2017, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot# M036058, expiration date: 19-MAY-2019; lot# M046133, expiration date: 26-SEP-2019; lot# M046134, expiration date: 27-SEP-2019 (dose and route of administration were not reported). There were no adverse effects. Administered doses of vaccines were stored in temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 2 hours. Digital Data logger was used to capture temperature excursions. There were no previous temperature excursions. No Product Quality Complaint (PQC) was involved. The nurse stated that the reason for temperature excursion was the refrigerator needing service. It was also added that there were no other temperature excursions once the service was completed. Reporter also stated that she would call back with the information regarding patients who received improperly stored vaccines. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007277: US-009507513-1705USA007279: US-009507513-1703USA005900.
Pt presented back to clinic at 10:40 with questionable dyspnea, urticaria of face, wheezing, O2 sats at that time were 89%. He was given 25mg of Benadryl Elixir at 10:45, applied nasal O2 and given Epinephrine 0.2 ml of 1:1000 sol at 10:45 along with Albuterol nebulizer 0.5cc/2cc NS at 10:50. O2 sats increased to 100% at 10:55 with good aeration and lessening urticaria. Transported to ER with nasal O2 for observation and further treatment.
mom states that pt had a shrill cry for 6 hrs following immunization (reported 18NOV94 @ subsequent visit);
herpes; post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On an unknown date, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live(ZOSTAVAX), patient suffered multiple outbreaks of herpes zoster, herpes and postherpetic neuralgia. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care.         As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered all events to be related to Zoster Vaccine Live(ZOSTAVAX).  Herpes zoster, herpes and postherpetic neuralgia were considered to be disabling.
Paresthesias in all 4 extremities. Constant tingling in both feet, intermittent tingling and electric shock sensations in both legs, buttocks, and upper extremities. No improvement since symptoms started. No treatment as of yet.
Information has been received from a RN concerning a 78 yr old female who on 30Nov05 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 650648/0967P), IM in the deltoid. On 30Nov05 the pt had a local reaction described as redness, pain and swelling. At the time of the report, the pt was considered to be not recovered. Unspecified medical attention was sought. The reporter would like a lot investigation for lot 650648/0967P). The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. It was also reported that another pt had a similar reaction (WAES0512USA00209). Additional information has been requested.
he blew a blood vessel in the left eye after this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-013231 (Moderna).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: 301348A) for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: ZOLPIDEM; AMITRIPTYLINE; LISINOPRIL; METOPROLOL; MONTELUKAST; SENNA [SENNA ALEXANDRINA LEAF]; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B3. Vaccination history included: BNT162b2 (Dose 1, Batch Number: EL3246, Route: Intramuscular, Indication: COVID-19 vaccine), administration date: 17Jan2021, for Covid-19 Immunization; BNT162b2 (Dose 2, Lot number of the second Pfizer COVID-19 vaccine: EL9262, Expiration of the second Pfizer COVID-19 vaccine: Unknown), administration date: 06Feb2021, for Covid-19 Immunization, reaction(s): "he lost eye sight for 3 months". The following information was reported: EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "he blew a blood vessel in the left eye after this". Clinical course: He had the first Pfizer COVID-19 vaccine on 17Jan2021 at the facility in contact 3. He had the second Pfizer COVID-19 vaccine on 06Feb2021 at the facility in contact 4 stating he lost his eye sight for 3 months. He had his first Pfizer COVID-19 booster vaccine on 26Sep2021 at the facility in contact 4 and stated he blew a blood vessel in the left eye after this.  No follow-up attempts are possible. No further information is expected.
Right arm (near tricep) swelling, a big lump and redness occurred with itching.
On March 6, 2021, I received the Johnson and Johnson Vaccination at about 8:15 am.  Around 7:00 pm that evening I started to experience the normal symptoms that they had advertised. Yes, I felt like I COVID again for about 48 hours, but nothing alarming.   On March 12, 2021, I went to an appointment with doctor due to extreme abdominal cramping and very heavy period.  This is not totally out of the norm due to my infertility, but I felt like something was off. I had random abdominal bruising and ruptured cyst pain; which I am still experiencing. She ordered an ultrasound to rule out a mass in my uterus due to the extreme pain and bruising.   On March 22, 2021, I woke up at 3:00 am with extreme stomach pain and extreme diarrhea.  As the morning went on I began to feel worse and worse. Other symptoms I experienced were; severe headache, shortness of breath, heartburn (I felt like I was having a heart attack), nausea, back pain, and extremely tired.  At 6:30 am  took me to the ER due to my worsening symptoms. Everything checked out fine and they thought I could have an ulcer, but I wanted to make you aware of these symptoms that I experienced.   I still have days that I experience some of these symptoms, but they have been under control and monitored closely.
Pt recv  vax on unknown day; post vax pt exp flu-like sxs
Headache, poor appetite, severe leg pain. My son could not walk on it for 2 days. On the leg shot was administered, patient would not bend his knee and would keep it straight.
No. Pt received a second Moderna bivalent booster today, 1 month and 3 days after an initial Moderna bivalent booster.  Pt had also received the initial series and a monovalent booster previously.
Second day chills & fever cough lasted several days running nose - fatigue got shot every year - never any problem before.
This spontaneous report has been received from a health worker and refers to some unspecified patients. Since 30-DEC-2014, doses of PROQUAD (Merck) which had been exposed to a temperatures of 11 degrees F for 51 hours cumulatively (supported temperature excursion) had been administered to unspecified patients. Vaccine of PROQUAD (Merck) should be stored frozen between -58 degrees F and +5 degrees F. No adverse effects have been observed or reported. This is one of several reports from same reporter. Additional information has been requested.