chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female patient with a history of natural varicella as a child, who was also a physician and the mother of a 14 year old patient who on 14-NOV-1996 was vaccinated with a first dose of VARIVAX (Merck) (Lot # not provided) and on 16-APR-2010 her son received a second dose of VARIVAX (Merck) (Lot # 665969/1447Y), 0.5 mL, SC in the right upper arm. On the same day the boy received a dose of tuberculin purified protein derivative vaccine. It was reported that the mother contacted the physician's office on 28-MAY-2010 and stated that she now had shingles, which began two weeks after her child was vaccinated with VARIVAX (Merck) (approximately on 30-APR-2010). The patient was treated with acyclovir. Follow-up information was received from the registered nurse who reported that the female patient, who had had a mild case of chickenpox as a child, developed shingles by her C-5 clavicle and up, three weeks post vaccination of her son (approximately on 07-MAY-2010, previously reported as two weeks post son's vaccination). The patient took acyclovir. Shingles rash lasted 2 to 3 weeks and at the time of the report, the patient still had some redness. This is one of several reports received from the same source. No further information is available.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Shakiness-Mild, Additional Details: Patient experienced discomfort when swallowing and stated it was probably due to her large lymph nodes. Rph asked if patient had trouble breathing and offered epinephrine but patient denied sob/dyspnea and could hold a conversation/answer questions. Rph called emergency services at 5:54 pm and paramedics arrived around 6:01 pm. Patient was alert and aware of her surroundings and was able to answer paramedic's questions. Rph expressed feelings of speedy recovery and asked patient to follow up.
Today on 8/28 I woke up to a swollen face on my right side. It hurt to touch and to even blink or squint. I had to call into work due to the circumstances. I couldn?t sleep very well because even the ear in that side of the face felt swollen as well. I put a cold compress on it twice then went to sleep and woke up to the swelling going down. Then I took Tylenol to help with the pain which hasn?t fully worked. My face is still swollen.
a seizure in the temporal lobe of the brain; developed tinnitus; a large cold sore on her lower lip; a bright flash of light and large boom- seemed like an explosion inside her head/Episodic cranial sensory shock/Exploding head syndrome; neurological event; sleeping a her dream was interrupted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies eggs" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: GILENYA. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 43-year-old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0168, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), for COVID-19 immunization, reaction(s): "sleeping difficult", "tinnitus ringing in ears". The following information was reported: EXPLODING HEAD SYNDROME (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "a bright flash of light and large boom- seemed like an explosion inside her head/Episodic cranial sensory shock/Exploding head syndrome"; ORAL HERPES (non-serious) with onset 13Apr2022, outcome "recovered" (May2022), described as "a large cold sore on her lower lip"; SEIZURE (medically significant) with onset 13Apr2022, outcome "recovered" (2022), described as "a seizure in the temporal lobe of the brain"; TINNITUS (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "developed tinnitus"; NERVOUS SYSTEM DISORDER (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "neurological event"; SLEEP DISORDER (non-serious) with onset 13Apr2022, outcome "recovered" (2022), described as "sleeping a her dream was interrupted". Therapeutic measures were not taken as a result of seizure, tinnitus, oral herpes, exploding head syndrome, nervous system disorder, sleep disorder. Clinical courses: The patient again developed tinnitus within a week. She also developed a large cold sore on her lower lip that would almost heal then reappear. Lasted about 6 weeks. During that time she also had another neurological event. While sleeping a her dream was interrupted with a bright flash of light and large boom- seemed like an explosion inside her head. She had learned since it was Episodic cranial sensory shock or also known as Exploding head syndrome, it can be related to tinnitus or a seizure in the temporal lobe of the brain. No other vaccine in four weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 808C21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, 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 experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.            Patient had no concomitant medications but states he was crippled. He has taken no medications for his side effects.   This case was linked to MOD-2021-400055, MOD-2021-400030 (Patient Link).
Fussy, irritable, high fever (103.9), unable to sleep, rapid breathing (50 breaths per minute) rapid heart rate (160 bpm).
Patient complains for numbness and tingling to right forearm.  Some discomfort at injection site.  States the right arm feels heavy. There is not skin color changes, no swelling or discharge visible at injection site.  Mild tenderness to palp.  Full ROM of right shoulder, elbow, and wright.  Able to discriminate between 2 vs. 1 point in lateral, medial and posterior plane of right forearm, difficulty to discriminate between 2 vs 1 on anterior lane of right forearm.  Able to distinguish between soft and sharp in all 4 planes on the right forearm.  Patient does have lymph node swelling in bilateral axillary and this is chronic finding to her.  This is not worse since immunization.  No evidence of cellulitis.  Strength +5 bilaterally to the upper extremities.  DX  Paresthesia of skin.  Apply ice to the right arm for 20 minutes at the times for next 48 hours.  Take Tylenol 650 mg every 6 hours if needed for discomfort.  One time dose administered in clinic.  Follow-up on symptoms 4/20/21.  Patient did not come for follow-up appointment.
10:15 Post vaccination reports feeling dizzy and anxious; medical monitoring x 30 min, rest w/po hydration offered, vitals assessed: BP 164/95 P 108 RR 19;  10:55 Denies any additional complaints or symptoms/ none noted, BP127/88 P74 reports "feels better". Released home w/self.
20 1/2 cm x 13 cm area of erythema (R) upper arm; entire (R) upper arm red, warm, & swollen.
The day after the injection, I had the normal reaction (headache, fatigue, nauseous, etc). Back to normal the following day.  Six days after  the vaccine -- the area around the injection site became very itchy and red. On day 7 and 8 there was tenderness, swelling, red and itchy. I took Advil on day 7 and 8. Day 9....symptoms have improved dramatically.
Extreme headaches lasting 10 hours a day.  Cold like symptoms for a few days immediately following vaccine
Reconstituted incorrectly, only given the Lyophilized MenA component and reconstituted in sterile water. Patient reports no reactions.
No additional adverse events reported; a dose of Improperly Stored VARIVAX has been administered to a patient; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.   On 18-JAN-2022, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (route not reported; lot #U020244, expiration date 28-JUN-2023) for prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion in the range 6 Fahrenheit degrees up to 14 Fahrenheit degrees (13.8 Fahrenheit degrees) for 1 hour 45 minutes and 0 seconds, and in the range 14 Fahrenheit degrees up to 46 Fahrenheit degrees (14.4 Fahrenheit degrees) for 0 hours 25 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse events reported.
Vaccine administered one day beyond manufacturer's expiration date of 11/28/2022.  Patient notified on 11/30/2022.  She is not experiencing any adverse symptoms at this time.  Online Adverse Event report filed with Moderna as well.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 13:00 as dose 1, single (Lot number: En9264), in left arm and on 27Feb2021 at 09:00 as dose 2, single (Lot number: En6203) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Dec2021 at 15:30 as dose 3 (booster), single (Lot number: 029h21b), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 18Jun2022, treatment stop date: 22Jun2022.
Temp of 103.7, heart rate 120, respirations 36, Blood pressure 164/60, Oxygen level 94% @ 2 liters per nasal canola. States does not feel well. Flushed face with heavy breathing. Transported to Medical Center ER.
Pt recvd vax & exp swelling, redness & fever for 1 day; fussy, redness, swelling to inject site; rt lateral upper thigh w/5-6cm indurated erythematous area; poss allergic react;
This case was reported by a healthcare professional and described the occurrence of pain in hip in a 43-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On 24 January 2008 at 13:30 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm.  On 25 January 2008 (11:00) 1 day after vaccination with TWINRIX, the subject experienced pain in the hip, had trouble walking and developed a rash.  The subject experienced a systemic reaction.  On 27 January 2008, the subject's hip pain resolved and he was able to walk without a problem.  As of 28 January 2008, the subject's rash had improved, but it had not completely resolved.  The healthcare professional considered the events were possibly related to vaccination with TWINRIX.  Follow-up information received 28 February 2008 confirmed the previously reported events.  It was reported that the rash experienced by the subject had a hive-like component on both inner thighs and some on the upper thighs.  The rash later developed into a chicken pox - like rash, then scabbed over.  The subject developed pain in his hip joints that progressed to severe pain, leading him to go to bed.  He was unable to walk due to the pain.  By approximately 16:00 on 27 January 2008, pain had subsided completely and the subject returned to an ambulatory state.  By 28 January 2008, 13:00, only a small amount of the rash was still present and by 04 February, the rash was gone.  The events were reported to have ended by 04 February 2008 and were considered by the reporter to possibly be related to TWINRIX.  The TWINRIX immunization series was discontinued.
Cellulitis - Evening 10-18-07 hospitalized 1 day. Pneumonia - Evening 10-21-07 Hospitalized 8 days. 1/4/08-records received for DOS 10/25-11/2/07-DC DX: Pneumonia. C. diff. colitis.  Presented to ED with 1 day HX rigors, disorientation.  Temp 102,  Diminshed sounds in RLL. No cellulitis.On day 4 became acutely drowsy and unable to stay awake. . Spiked fevers. Loose stools and history of c. diff.
pt recvd vax 21SEP95 & devel petechiae; 5 new ones appeared over next 5d as other went away; plts 322K
DTAP and Polio ordered for 7 month old patient, given KINRIX by mistake instead.
inadvertently administered the vaccine by intramuscular injection; This case was reported by a nurse via other manufacturer and described the occurrence of inappropriate route of vaccination in a 1-month-old patient who received Rota (Rotarix lyophilized formulation) (batch number AS35G, expiry date unknown) for prophylaxis.   On 18th October 2019, the patient received Rotarix lyophilized formulation (intramuscular). On 18th October 2019, unknown after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was inadvertently received a dose of Rotarix by intramuscular injection, which led to inappropriate route of vaccination. The patient did not experience any symptoms. The reported batch number was updated from AF35G to AS35G, as per sales data sheet.
Received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid; Received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid; This is a spontaneous report from a contactable Nurse. A 59-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid and was given monoclonal antibody -Bamlanivimab on an unspecified date. She was directed by her physician and the manufacturer of bamlanivimab (monoclonal antibody) to wait 90 days to get 2nd dose of the covid vaccine. The patient underwent lab tests and procedures which included Covid which was positive (received her first dose of the Pfizer BioNTech covid vaccine then became positive for covid) on an unspecified date. The outcome of the events was unknown.  Information about batch/Lot number has been requested. ; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19  cannot be totally excluded
Vaccine was given 1 week after BUD.   I spoke to patient on 6/9 about the issue as above and her father reported that she seemed fine and that she was feeling more tired than usual which was similar to prior reaction to covid vaccines.
Noon time arm was painful and felt hot;by 3:30 pm high gever chills (no temp taken), no appetite & arm swollen around from elbow to below axilla.  By 3:00 am the next day (11/18/06) felt better, swelling down but bruised on entire upper (from elbow to shoulder)appetite returned, and some coughing from cold. Client believes he had contracted a slight cold around the time of the immunization and at the time of the immunization adamant at denying previous PPV-23 vaccine.  (Noted later on investigation with local provider that one was given 5/27/05).
I started to feel a mild pain in the chest from the first night after my first shot of Moderna with a fever and extremely pain arm. Next day during the daytime, my fever got away, as well as the pain arm. But during the night, my chest was pain enough to wake me up and kept in pain.
Swelling, red, warm, blotchy raised rash, as soon has shot was given. Patient had to wait in office for 20 minutes, after 20 minutes rash begain to fade. Patient went home with mother. This is the third reaction like this in a month, to the MMR.
No adverse event; Patient received an expired monovalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent dose).    No concomitant medications were reported. Vial size was reported as 2.5 mL.. Vial was initially stored in the refrigerator on 01-Nov-2022.Vial did not undergo any temperature excursions. No treatment information was provided.
Patient went to ER 8/13/09 with complaint of swelling in arm, redness and fever. ER visit 8/13/09 temperature = 100.1, BP 106/74, patient was placed on Doxycycline 100 mg PO BID, VICODIN 5mg, 1 or 2  tabs every 6hrs prn.  Dx: cellulitis
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # J014407, expiry date 13-NOV-2015) (lot # L000454, expiry date 06-JAN-2017) (dose, route and dose number were unspecified). No adverse effect was reported. Additional information has been requested.
Redness, warmth, swelling and pain over left deltoid.  She took Benadryl 50mg. PO at 1930 without significant relief of symptoms. Denies pruritus, other rash, wheezing, SOB, throating swelling, chest pain/tightness, diarrhea, fevers, chills.
First shot was sore neck about twenty minutes after, headache a couple hours later, headache lasted until next evening and next day also had fatigue and sore muscles and was fine next day Second shot was achy,exhausted, and did not feel good until next Tuesday, I received second shot on Feb 25, 2021
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. Since 15-SEP-2014, unspecified number of patients have been administered improperly stored doses of PROQUAD (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse events were reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse via a company representative, on behalf of the patient's mother, concerning a currently 24 year old female patient. The patient's historical condition, concurrent condition and concomitant therapy were unknown. On an unknown date (also reported as "years ago"), the patient received the 1 dose of GARDASIL (strength, dose detail, route,  lot# and expiration date were not reported) for prophylaxis. As it reported, the patient received all 3 doses of GARDASIL at unspecified age, with unknown dose detail, route,  lot# or expiration date. The patient's mother reported that her daughter experienced personality change which she described as "moody" on unknown date. At the time of reporting, the outcome of personality change and moody was unknown. The causality assessment between GARDASIL and the aforementioned events was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA001902.
Patient had temp of 101.5 degrees, left arm swollen 12cm in diameater, tender, pink, localized reaction.
Symptoms - Normal screening mammogram; diagnostic mammogram with ultrasound ;needle biopsy - breast cancer was confirmed at that point. Diagnosis was Invasive Ductal Carcinoma. I had a lumpectomy with removal of four lymph nodes at an outpatient center. No other treatment yet. I need to get radiation next.
got the 2nd dose beyond the approved time frame in refrigerator; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator) in an adult 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator) had resolved.            No concomitant medications was reported. No treatment drug details was reported.  Age of the patient was mentioned as mid 20s but not provided exactly.   This case was linked to MOD-2021-358910 (Patient Link).   Reporter did not allow further contact
Fever, shaking, chills.  Resolved within 48 hours without mild diarrhea, mild redness at injection site.