chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ocean sound in head making not sleep and not put head down/whistling in head; ocean sound in head making not sleep and not put head down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: TINNITUS (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down/whistling in head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down".  Additional information: Reporter called about an "ocean sound in their head" making them not sleep and not put their head down. Also, there was a whistling in their head while on the phone. Reporter stated that she knows five people off the bat that has the same experience.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124718 same reporter, product and event, different patient;
Within 45 minutes of vaccination - developed red face with tingling; recipient felt "extremely warm". Patient was medicated with Benadryl 100mg and felt fine after a short period of time.
Rash appeared on right side of face 3 days post vaccination.  Rash has spread to the entire face.  Patient tried Benadryl 3-4 days with no improvement in rash.  Saw PCP on 4/30 - given a steroid shot, prednisone tablets, and a cream.
Information has been received from a physician concerning a 4 year old male with no allergies or medical history who on 5/1/2001 was vaccinated IM in the right arm with a 0.5ml first dose of varicella virus vaccine live (lot 636574/1466K). Concomitant therapy included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. On 3/8/2005, the patient developed severe pneumonia immediately following the crusting of a lesion. It was progressive and the patient was hospitalized for two weeks. The patient had two chest tubes and Iv vancomycin and ceftriaxone sodium (Rocephin) for one month. On organism was recovered but MRSA was suspected. At the time of the report, the patient had not recovered. Follow up information was received from the physician who reported that on 3/8/2005, the patient had varicella consisting of mild skin lesions but subsequently had within 48 hours severe pneumonia requiring a chest tube and intravenous antibiotics for four weeks. It was noted that no organisms grew. The patient was hospitalized for two weeks. Additional information was received from the physician who reported that the patient is now better. The patient still has residual finding on X ray but is asymptomatic. No further information is expected.
Sore arm 4/24, am Severe fatigue 4/24, pm Fatigue 4/25, all day 4/26, all day - severe body aches, severe fatigue,  low fever, chills,  severe headache,  nausea  4/27 - headache,  nausea  4/28 - headache,  nausea
Small nodule to each side of her face at the marionette lines; This spontaneous case was reported by an other health care professional and describes the occurrence of NODULE (Small nodule to each side of her face at the marionette lines) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product HYALURONIC ACID, LIDOCAINE (RESTYLANE L) for an unknown indication.    No Medical History information was reported.   On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient started HYALURONIC ACID, LIDOCAINE (RESTYLANE L) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NODULE (Small nodule to each side of her face at the marionette lines). At the time of the report, NODULE (Small nodule to each side of her face at the marionette lines) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received Restylane Lyft on 13-APR-2021. She received 0.4 mL to each cheek (0.8mL total); 0.4mL to each marionette line (0.8mL total) and 0.4mL to her chin. Total of two syringes of Lyft were given her. Fast forward to this year. Patient would like to get more filler. She mentioned that she experienced a small nodule to each side of her face at the marionette lines, almost immediately from that initial visit, but she did not report it to anyone. Today (10-JUN-2022) one nodule has resolved on its own, and the remaining nodule has shrunk-- it's now the size of a BB.
Six days after receiving the Pfizer vaccine, patients developed transient ischemic attacks.  Had a full evaluation at Medicine Center.  Work up negative and symptoms resolved; atorvastin dose was doubled.  He has had some short term memory loss and decrease in neurocognitive function.  He had the second dose of the vaccine as scheduled, following which he had a severe unilateral headache but he did not seek care/evaluation.
Covid arm, 2" diameter red circle,  arm itch, Covid toe, right foot, small toe
PT.HERE STATED AREA WHERE VARICELLA WAS GIVEN WAS SWOLLEN, RED AND TENDER TO TOUCH SINCE WEDNESDAY MORNING. OBSERVED LG. 20CM X 18CM RED WHELPED AREA TO LT. OUTER ARM. AREA WAS SL. WARM TO TOUCH. PT. GIVEN HYDROXIZINE 25MG TID AS NEEDED, PER MD. INSTRUCTED PT. TO PUT WARM COMPRESSES TO AREA AND RETURN TO CLINIC IF SX. WORSEN.WILL FOLLOW UP ON PT. IN 7DAYS.
Information has been received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patient vaccinated with the improperly stored VARIVAX (lot # M010481, expiration date of 01-MAR-2018; route, dose and frequency were unknown) reconstituted with properly stored sterile diluent (manufacturer unknown), for prophylaxis (incorrect product storage). No adverse effects were reported. The administered doses of vaccine was underwent the temperature excursion from 47 to 77 degrees Fahrenheit for 10 hours 30 minutes. The previous temperature excursions was reported as from 47 to 77 degrees Fahrenheit for 2 hours. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of four reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000552: US-009507513-1709USA009700: US-009507513-1709USA009698:
Mom noticed redness around neck later in day after vaccinations.Pt has a pink-red collar-like ring around neck. Given Benadryl in office.                                                Addendum to #21: HIB at 4 mo. SP UF441AA;              PCV at 4mo.  WLV D07543                ROTATEQ  at 4 mo  MRK 0967X
Neuromuscular symptoms of excess saliva, dropped neck, shuffling, eventually diagnosed with ALS on 8/29/2022.
Acute fever 101 degrees and headache the night after vaccination that resolved after 2 days  Chronic pain at the injections site 2/10, dull, aching pain
Swelling, redness, hardness, itching, hot to touch at injection site that started 6 days after and spread across upper arm
This spontaneous report as received from a billing manager refers to an unknown number of child patients of unknown ages or genders. No information was provided regarding the patients' concomitant medications, pertinent medical history, drug reactions or allergies. On multiple dates since 13-OCT-2017 until 17-FEB-2017, unspecified number of patients received improperly stored doses of ROTATEQ, orally (exact dose and dose number were not reported; lot # N010707 with the expiration date of 03-DEC-2018, and lot # N000193 with the expiration date of 20-OCT-2018) for prophylaxis. On multiple dates since 20-NOV-2017 until 20-FEB-2018, 18 unspecified patients received improperly stored doses of M-M-R II (therapy type recombinant Human albumin (rHA); exact dose, dose number, route of administration were not reported; lot # N009172 with the expiration date of 20-MAR-2018) for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute M-M-R II was stored properly. On multiple dates since 22-NOV-2017 until 21-FEB-2018, 19 unspecified patients received improperly stored doses of GARDASIL 9 (exact dose, dose number, route of administration were not reported; lot # N017686 with the expiration date of 02-FEB-2020) for prophylaxis. On multiple dates since 13-DEC-2017 until 23-FEB-2018, 20 unspecified patients were vaccinated with improperly stored doses of VAQTA (exact dose, dose number, route of administration were not reported; lot # N020689 with the expiration date of 22-OCT-2018) for prophylaxis. No adverse effects were reported. The administered doses of vaccines underwent multiple temperature excursions since 10-OCT-2017 (also reported as since 06-OCT-2017). Digital data logger was involved to capture the temperature excursions. This is one of two reports received from the same reporter. Sender's Comments: US-009507513- 1803USA012773.
Dizzy, pale, ringing in ears, blurry vision all subsided after 20-30 min. Sore arm for 2 days.
daughter with covid at home last week and then she had sx 16May and Ag positive 17May; daughter with covid at home last week and then she had sx 16May and Ag positive 17May; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. The reporter is the parent.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 16Mar2021 as dose 2, single (Lot number: EL3247) and on 15Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16May2022, outcome "unknown", COVID-19 (medically significant) with onset 16May2022, outcome "recovering" and all described as "daughter with covid at home last week and then she had sx 16May and Ag positive 17May". The events "daughter with covid at home last week and then she had sx 16may and ag positive 17may" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical information: Other vaccine in four weeks was unknown. COVID prior vaccination was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID - 19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vaccine was stored in freezer and took out one or two vials and place in freezer each day as needed.
This spontaneous report as received from a health care worker refers to a 37 year old female patient with no drug reactions or allergies. Pertinent medical history was none. On 20-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number was reported as H04196, expiry date was 19-MAR-2014, dose was not reported), subcutaneously. Concomitant medical history was none. On 22-FEB-2013, the patient was seen in an unspecified emergency room due to severe pain in the injection site and fever. No laboratory test was performed. The patient was diagnosed with cellulitis at the injection site and was prescribed BENADRYL, BACTRIM and VINCODIN and was sent home. Patient sought medical attention and again on the 22-MAR-2013, the patient was seen in the physician's office and was prescribed KEFLEX and prednisone. Approximately on an unknown date in 2013, the event of cellulitis at the injection site was recovered/resolved. Additional information has been requested.
No additional AE reported; Temp excursion 47.9 F; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the 1st dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W023937, expiration date: 06-DEC-2023 (both confirmed to be valid), administered intramuscularly into the left thigh for prophylaxis (strength and dose were not provided). The vaccine was improperly stored for 47 minutes in the temperature of 47.9 degrees Fahrenheit. The temperature excursion occurred as a result of a reading from a Digital Logger. It was not reported if there was a previous temperature excursion. The was no other adverse events reported (no adverse event).
Patient had immediate sensitivity reaction on left leg/thigh with administration of MMR/Varicella vaccine. Diffuse erythema and urticarial over the thigh. No respiratory Sx's. Appearance seemed to be improving at the time of discharge (5 min) cool compress applied immed. 7 hr. later P.C. w/ FOC no problems reported left thigh clear.
Information has been received from a physician concerning a male patient who within the last 2 months in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 643249/0358M). Subsequently in October 2002, the patient experienced a very sore arm, developed redness and swelling that went from his shoulder down his entire arm. The patient was treated with anti-inflammatory agents (unspecified) and subsequently, all of his symptoms resolved. The physician indicated that in his many, many years of experience with vaccinations, he had never seen such an inordinate amount of reports of severe reactions to pneumococcal vaccine 23 polyvalent as he had recently. He requested a lot check of lot # 643249/0358M. The record of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The patient sought unspecified medical attention. The physician also reported on other patient's experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent. Additional information has been requested.
6JUN91 wake up from nap t103.6 @ 5PM; 7JUN91 Seen by MD rt otitis med & culture positive for strep throat; Given Amoxyl & APAP; 10JUN91 Seen by MD ear better, throat better, t102.4;
The pt received her 1st injection of Hep-B vaccine on 1/25/01. That evening, she presented to the local ER with shortness of breath, itching and a rash. She was sent home from the ER. She returned to the ER, 24 hours later, on 1/26/01. She was hospitalized for 3 days. The dx and outcome of these events were not provided. F/U rec'd from treating physician on 3/9/01 indicated that the pt underwent unspecified allergy testing which was positive for allergy to hepatitis B vaccine. The outcome of the event was not specified.
Fever 105.2 right. Leg pain - would not move leg. Presented 24 hours after immunization.
TOOK ALL THE DOSES ON CONSECUTIVE DAYS; This case (PVX2019-2200) was received from a consumer on 28-Aug-2019. It described a male consumer who "took all the doses on consecutive days" (PT: Inappropriate schedule of product administration), while being on Vivotif for an unknown indication.  Case report: The consumer took all the doses of Vivotif on consecutive days, last week. He stated that he would be travelling on 11-Oct-2019.  Action taken with Vivotif with respect to the events was not applicable.  The clinical outcome of reported events was unknown.  Company's Comment: The causality of the event "took all the doses on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took all the doses on consecutive days" was considered as not applicable.
This case was reported by a nurse and described the occurrence of injection site pain in a 63-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020) for prophylaxis. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 10th April 2018, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 07-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Initial report received on 11 November 2009 from a company representative for the manufacturer, who is a health care professional. A 13-month-old male patient had received a dose of H1N1 (lot number not reported) on 09 November 2009 that had been drawn up into a plastic syringe four days prior and kept in a refrigerator until it was given. The same day after vaccination, the patient developed "cold like symptoms". According to the father who is a physician, the patient had a cough at the time of the vaccination. No relevant diagnostic tests or laboratory data were performed. At the time of this report, it was unknown if the patient had recovered. Follow-up information received 04 December 2009 from a health care professional. The vaccine had been drawn up into a plastic syringe three days prior to administration (previously reported as four days). According to the reporter, the patient had a cold at the time of vaccination and did not experience any adverse event. The patient recovered from their cold symptoms with no issues and tolerated the vaccine well. No further information was provided. Documents held by sender: None.
mild case of varicella has been vaccinated 23FEB96;afeb onset of lesion (x4 small lesions) x 3 days;
earlier report filed yesterday addendum to prior report (initial symptoms of HA, vertigo, sweating and then chills) - see prior report filed 2/4/2021 - as patient ready for discharge, she then developed  Urticarial rash - treated with Epinephrine 0.3 mg IM, oral benadryl and famotidine with resolution of rash
tenderness in her left arm for the first two doses; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Feb2021 12:15 (Lot number: EL3302) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; VITAMIN B12 [CYANOCOBALAMIN]; CALCIUM; CINNAMON. The following information was reported: TENDERNESS (non-serious) with onset 2021, outcome "unknown", described as "tenderness in her left arm for the first two doses". No follow-up attempts are possible. No further information is expected.
Systemic: Non-specific reaction occured approximately 1 hour post-vaccination. Patient unable to provide clear answers regarding symptoms; symptoms lasted 0 days
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 30-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).