chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 79 years old male patient. The patient was vaccinated with ZOSTAVAX in October 2011 ("a year ago") (route, dose, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. At an unspecified date in approximately 2011, the patient developed shingles in the ophthalmic dermatome and was prescribed an unspecified ophthalmic ointment as a treatment. The pharmacist stated that the patient did not develop any post-herpetic neuralgia. The pharmacist was uncertain if the patient has recovered fully. The patient sought unspecified unspecified medical attention. The relatedness for shingles in the ophthalmic dermatome is unknown for ZOSTAVAX. Additional information has been requested.
adult patient given pediatric dose; adult patient given pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B) (batch number 2SNM39, expiry date 16th March 2024) for prophylaxis.   On 4th March 2022, the patient received Engerix B. On 4th March 2022, unknown after receiving Engerix B, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The reporter was a pharmacy intern. The reporter reported that an adult patient was given a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter did not consent to follow-up.
Patient is an employee that chose to vaccinate employees for Rabies. Patient received two of three doses of series ( 3/26/03 and 4/3/03 ) Mother of patient called today to report a general rash that has been increasing over past two weeks.Taking daughter to Dermatologist and request Rabies vacc insert be sent to the doctors office.
This spontaneous report concerning a 66 years old female patient with arthritis was received from the patient herself. Medical history was not reported, however, the patient stated that she had no allergies. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (strength, dose, route, frequency, lot and expiration date were not provided). Concomitant medications include an unspecified diabetes medicine. On an unknown date in 2014, the patient experienced shingles rash, but she stated that she did not have any pain. The patient did not sought medical attention. Additionally, no laboratory diagnostic studies were performed and no treatment for the adverse event was given. No product quality complain was involved. At the time of reporting, the outcome of herpes zoster was reported as recovered on an unknown date (also reported as the adverse event did not improved). The reporter did not consider the event of herpes zoster life threatening or medically significant. The causality between the event of herpes zoster and ZOSTAVAX was not assessed. Additional information is not expected as the reporter did not consent for follow-up attempts.
G6P4 Patient with estimated due date of 9/17/2021 presented for 20-week ultrasound on 5/4/2021. No heartbeat detected, diagnosis of 2nd trimester intrauterine fetal demise of fetus weighing approx. 300 grams delivered after induction of labor on 5/6/2021. Previously uncomplicated pregnancy with FHT last auscultated on 4/19/2021. 4 previous uncomplicated full-term deliveries. 1 miscarriage at ~8 weeks between first and 2nd pregnancy in ~2008
This spontaneous report as received from a pharmacist refers to a 65 year old male patient with lichen planus, elevated cholesterol and unspecified thyroid condition. The patient had no drug allergy. On 13-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # H019999, 0.65 ml, one time subcutaneous in the left arm. Concomitant therapies included atorvastatin, levothyroxine sodium (manufacturer unknown) and SORIATANE. On 14-FEB-2013, the patient experienced redness, swelling and soreness of his left arm at the injection site. No treatment was given. No lab test was done. At reporting time, the patient was not recovered from the events. The patient went back to pharmacy to seek medical attention. Additional information is not expected.
The first dose resulted in Graves disease, with an acute hyperthyroidism , palpitations, fatigue, nervousness, anxiety and irritability. Unintentional severe weight loss and imsomnia. Coughing, and bronchitis
early, heavy period; early, heavy period; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EV0142, expiry date was not provided) via Intramuscular route, at Left arm, on 06Jan2021 17:30 as single dose for COVID-19 immunization, at hospital. Patient's medical history included congenital adrenal hyperplasia, late, light periods and COVID-19 (Prior to vaccination, patient was diagnosed with COVID-19). Concomitant medications included methylprednisolone, colecalciferol (VITAMIN D) and cetirizine hydrochloride (ZYRTEC); all these medications received within 2 weeks of vaccination. Patient had no Allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. It was reported that, Prompted an early, heavy period on 11Jan2021. No none other stressors. Patient had history of late, light periods. This one came 2 weeks early and was significantly heavier than usual. Facility the most recent COVID-19 vaccine was administered to hospital. No treatment was received for these events. Seriousness of the events was reported as non-serious. Outcome of the events was recovered in Jan2021.
Fever low grade 2/24/2021,  joint aches and headache,  Next day had higher fever 100.8F and more joint aches and headache.   I generally felt like I was getting the flu.  On 2/26/2021  fever broke, still sore.   NOTE:  The evening of 2/24/2021 there was a swelling, itching and hardness about 3 inches toward the front of my arm, and that resolved itself by 3/5/2021.  On 4/1/2021 I began to have shingles symptoms. Symptoms included itching, burning, stinging and pain from right of spine between ribs and waist progressing towards the front of the body. Went do Dr. 4/6/2021, was diagnosed with SHINGLES and was prescribed antivirals. After 5 days, my shingles symptoms have shown some improvement.
Approximately 10 days after vaccine right arm (bicep) area around injection was red. Experienced flu like symptoms the following day red area was even larger approx 5 inches radiating more towards the collar bone. Seen in the ICC for possible smallpox vaccinations reaction. Treated with Keflex and sent home. Two days later (25Jul04) followed up with ICC and followed up with Surgeon today. The redness had decreased some but is still noticeable where the swelling and redness was and where it was going.
persistant screaming x 3 hrs 9PM-12AM p/vax & intermittant, screaming until 23 hrs PM next day;
fever, muscle and joint pain, significant high fever, severe sinus headache, exhaustion. Symptoms started about six hours after injection. I had a significant fever that lasted for 18 hours. The first night I was unable to sleep because the body soreness and pain would not allow me to get comfortable. I started taking Tylenol shortly after the symptoms started but it did little to mitigate the symptoms during the first 24 hours. By the end  second day following vaccination, symptoms were beginning to subside. On the morning of the third day, I pretty much back to normal.
Fatigue; insomnia; Visibly swollen lymph node near collar bone on injection side; Lymph node pain; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and gastrointestinal issues of undetermined origin. The patient had allergies to food dye, iodine, fenugreek and penicillin. The patient previously took cefalexin (KEFLEX) for unknown indication and experienced drug allergy. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), 10 mg and vitamins nos  and various supplements  for unknown indications from unknown start dates and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 for first 24 hours ,the patient experienced fatigue, followed by insomnia for next 48 hours. On day 2 and 3 after receiving vaccine ,lymph node pain, most pronounced and visibly swollen lymph node near collar bone on injection side; swelling persisted on  day 5, though pain faded after day 3. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events fatigue, insomnia ,lymph node pain and swollen lymph node was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Approximately a day and a half after the shot I was starting to feel flu like symptoms , aches pains with severe stabbing headaches for a little over a week with the aches and pains but the severe headaches   continued for more than a month and continue even now on an intermittent basis . I spoke to the Pharmacist who advised me to contact this site.
This spontaneous report as received from a registered nurse refers to a 11 year old female patient. The patient's concurrent conditions included reactions/allergy to penicillin and cephalosporins (unspecified). On 07-SEP-2006, the patient received a dose of VARIVAX (Merck) subcutaneously (dose, lot# and expiration date were not provided). On 01-SEP-2009, the patient received a dose of PROQUAD (Merck) subcutaneously (lot# reported as 0845Y, dose and expiration date were not provided). On 11-JUL-2015, the patient developed a 'low-grade fever (temperature unspecified). On 15-JUL-2015, the patient developed a 'varicella-like rash on the trunk area and down her right leg'. The patient sought medical attention - she went to see a physician. No treatment was given for the events. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and VARIVAX (Merck) and PROQUAD (Merck) was not provided. Additional information has been requested.
Patient received vaccine and approximately 15 minutes after patient had complaints of feeling dizzy. Vital signs were monitored and patient assessed by medical doctor.
patient states that she started with itching, redness, and swelling to the right arm and itching, swelling, redness, pain, and warmth t left arm Monday after a friend brought it to her attention. She states that the right arm symptoms subsided, but the left arm symptoms remained and she informed me Friday, October 22nd and I prescribed Medrol Dose Pak 4 mg as directed. I followed up Monday, October 24th and she states that left arm swelling, redness, itching, and pain has subsided with only a faint amount of redness noted and  mild warmth. I advised Friday and Monday for patient to be seen in clinic to ensure no cellulitis and she declined.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 03-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No Treatments were provided.
This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. Their medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, an unspecified number of patients received improperly stored doses of PROQUAD (lot # M042501-valid, expiration date 17-APR-2018) (dose and route unknown) for prophylaxis (incorrect product storage. No adverse effects were reported. Temperature was reported as 15 degrees Fahrenheit (F) to 46 degrees F (15.3 degrees F) for a time frame of 40 minutes. Previous temperature excursion was 15 degrees F to 46 degrees F (15 degrees F) for 3 hours and this was reported as a data logger. This is one of the multiple reports from the same reporter (US-009507513-1707USA008649 and US-009507513-1707USA008650). Additional information has been requested.; Sender's Comments: US-009507513-1707USA008649: US-009507513-1707USA008650:
vaccine was not properly reconstituted first; patient was given just the liquid; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that they had an extra lyophilized antigen powder vial and was missing the liquid adjuvant suspension vial. The reporter thought that they had a medial error. The patient was given just the liquid and that the vaccine was not properly reconstituted first, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The clinic was investigating to try to identify which patient this happened to and currently the patient information was unknown. The reporter agreed to follow up from GlaxoSmithKline.
headache; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored Program. A 34-year-old female patient (consumer) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Aug2021 (age at the time of vaccination was not reported), as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Aug2021 (reported 17 days after vaccination), she patient experienced headache. The patient received the first dose 17 days ago and has had a headache ever since. She asked if this was normal. The outcome of the event was reported as unknown.  Information about Lot/Batch number has been requested.
Monovalent mRNA vaccine administered for a bivalent mRNA dose.   Had not been notified (as of date of this vaccine  administration)  that monovalent vaccine had been discontinued). Notice wasn't released until 05-01-2023, sent via e-mail to my supervisor on 05-02-2023,  forwarded to me, where I read it the morning of  05-03-2023 at which time, then all remaining doses of monovalent mRNA vaccine was destroyed.  This patient had no adverse effects or event as result of this dose of vaccine given.  Patient was given Pfizer Bivalent Vaccine Lot GJ 3270, on 06/07/2023 and tolerated well.
Shingles after the first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's disease. Concomitant products included  (Humera).   On 29th May 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: After receiving the 1st dose of Shingrix the patient developed shingles. The patient needs to take Humera because had Crohn's disease  The reporter did not consent to follow up.
Patient received her flu shot and after 10 minutes she felt warmth and swelling in (R) arm (lump walnut size). She applied ice PRN. The next day there was bruising and on Thurs the bruise continued to her elbow. Bruise is resolving and no medical treatment was required.
Pain, swelling in the afternoon in the area of the injection (upper arm). Next day pain and swelling moving down to the area of the elbow. Third day (today 12/14/2012). some pain and some swelling below the elbow to about mid-forearm but mostly around elbow.
Received immunizations at 1400 9/19/06- to emergency department at 1800 9/19/06 with swelling to bilateral thighs with redness.  Mother allergic to beef.
Dizziness and headache started in the evening of 11/4. Beginning in the morning of 11/5, extreme dizziness, headache, nausea, vomiting, constant chills, and rapid heart rate. Dizziness, chills, and headache through the evening and night. This morning (11/6), dizziness and headache have continued, though less than yesterday.
Patient noticed localized erythema to left upper arm on 7-14-08 in PM.  Reports shoulder a little sore.  Has taken no medications, no interventions, or visits to PCP.  Denies SOB.  No reaction notified prior to 7-14-08.
started feeling lump in breast; turned out to be breast cancer upon evaluation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Jun2021 19:00 (Batch/Lot number was not reported), at the age of 40 years old, as dose 2, single for covid-19 immunisation. Medical history included prior breast cancer that was in remission. Has not been diagnosed with COVID prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 12May2021 11:00, at the age of 40 years old, for covid-19 immunisation. On 10Jun2021 09:00, the patient started feeling lump in breast 9 days after 2nd dose of Pfizer covid vaccine. It turned out to be breast cancer upon evaluation. This lump did not exist before taking the vaccine. Chemotherapy planned for 22Jul2021. The event was reported as serious (life-threatening and disabling). The patient had not recovered from the event.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours; No adverse event; Administer a vaccine to a pediatric patient past 12 hours of first puncturing; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing), PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     Patient did not had any allergies or both Acute and Chronic illnesses at the time of vaccination. It was reported that patient has never been diagnosed/tested positive for COVID-19.     On 08-Aug-2022 at 8:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing), PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administer a vaccine to a pediatric patient past 12 hours of first puncturing) and PRODUCT STORAGE ERROR (Vaccine punctured on 05-Aug-2022 was administered on 8AM on the 08-Aug-2022 after storing for 72 hours).    No concomitant medications was reported.  Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The event did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient has never experienced a similar event in the past.  The HCP administerd vaccine to a pediatric patient past 12 hours of first puncturing. The vial was expired on the 05-Aug-2022, and it was administer on the 08-Aug-2022. It was unknown, when the vial was initially stored in the refrigerator. The vial was first punctured on 05-Aug-2022 at 10:25 AM and for a total of 72 hours. It was unknown whether the vial was stored in room temperature or fridge post puncture. The vial did not undergo any temperature excursions.   No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2022: Follow-up received contains updated batch number.
8/7/03 P/C from Dr's office reporting swelling and redness of right arm 2 hours after DTaP given 8/5/03. Mom's report that symptoms started evening of vax and worsened 8/6/03. Child in MD office at this time. MD measured redness at 2cm and arm circ. of 21 cm. No obvious distress. Was given Keflex to take for 7 days for possible cellulitis.
pt recv vax & c/o seeing double vision, felt ill, color pasty, diaphoretic, pulse 80 7 thready;alert;BP 92/68;AP 80;states had only juice box for lunch;dizzy;stomach hurts;
Around the first of May, I noticed leakage of urine - I had a little prior to the vaccination, but by May 1st, it was much more pronounced and accompanied by urgency and frequency of urination.  I have to wear a pad at all time now.
pt recv vax 10AM 15MAY95 APAP given x 1 mid morning; mom awakened 2AM 16MAY95 to pt crying & screaming; pt was shaking & jerking for period of 10 mins; mom described episode as a sz, t102 ax that time; mom states pt fell asleep p/sz