chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH AFTER VACCINATION; This spontaneous report received from a consumer via a company representative through media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died 4 days after the vaccination. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event was fatal. This report was serious (Death).; Sender's Comments: V0: 20210915824-COVID-19 VACCINE AD26.COV2.S-death after vaccination. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I had mild fever for about 3 hours; Developed axillary lymphadenopathy / lymph node about 2 inches under my armpit had swelled up to the size of a golf ball; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Bnt162b2 (DOSE 3, SINGLE, Lot number: 30135BA,, Anatomical location: Left arm), for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 17Dec2022 at 19:00, outcome "unknown", described as "Developed axillary lymphadenopathy / lymph node about 2 inches under my armpit had swelled up to the size of a golf ball"; PYREXIA (non-serious) with onset 17Dec2022 at 19:00, outcome "recovered", described as "I had mild fever for about 3 hours". Therapeutic measures were taken as a result of pyrexia, lymphadenopathy.  Additional information: The patient received treatment of 2 tablespoons of ACV in water. The patient had no known allergies. 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.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
anxiety everyday soon after waking up; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included anxiety and panic attacks. Patient had been free of anxiety/panic attacks for 6 years. The patient's concomitant medications were not reported. Patient previously received the first dose of Pfizer Covid vaccine on 16Mar2021. The first week he felt fine, then the second week he began to feel his panic and anxiety increase and he had a panic attach in which he was admitted to the emergency department. The patient experienced anxiety everyday soon after waking up after the second vaccination. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
12 hours after injection total body aching and feeling cold started. Got up in middle of the night for bathroom . made it to bathroom before I couldn't hold urine. Remember thinking "O my gosh"  Disorientated trying to get back to bed. Kept running in to walls. 75 hours after injection still not fully recovered but feeling much more normal.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (route, lot#, dose and frequency unkonwn). No adverse effects were reported. It was unspecified if the patients sought medical attention. Additional information has been requested.
has a temperature over 100; Headache; Feels horrible; She doesn't feel well; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) dose 2 via an unspecified route of administration on 20May2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Historical vaccine included BNT162B2 for COVID-10 immunisation on an unspecified date as dose 1, single and experienced sore arm. No PQC was present. On 21May2021 the patient experienced has a temperature over 100, headache, feels horrible, she doesn't feel well. The patient underwent lab tests and procedures which included body temperature resulted over 100 Fahrenheit on 21May2021. Caller reported that she didn't feel like this after her first dose. She stated that she only had a sore arm for two days. Caller would like to know how long her side effects may last. Caller did not want to transfer to Pfizer. She stated that she doesn't feel well and just wants to get off the phone. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Patient 1st dose of COVID 19 Vaccination was March 12, 21 of Moderna COVID-19 Vaccine 0.5 ml IM in Left Deltoid Lot#; MOD; 026A21A; 08/26/2021. Patient reported for scheduled visit on April 9, 2021 and received Pfizer Vaccine in left Deltoid Lot#: ER8727 07/31/2021. Chief of Primary Care and assigned Team Provider notified. No adverse reactions noted. F/u with patient the next day. No issues verbalized.
Headache & Myalgia Narrative: headache and body aches 4/29/21, stayed home 24 hrs from work, then sx resolved.
Hypotension, dizziness; possibly precipitated by Percocet taken for post-surgery
Myalgia Per patient: "started haveing sinus drainage and muscle aches 2 days after and still going on no temperature, no diarrhea or loss of taste or smell" Narrative:
pt reported a/MD visit 30JUL96 a sense of numbness, tingling, & pain immed following inj 19JUN96;pt felt was less competent & less strong in baseball & many other activities;
Patient reported bruise on vaccinated arm (left) the size of a baseball with tenderness. No other reported common symptoms (denies fever, headache, nausea). Patient was vaccinated around 11:30am 9/29/2017 and first reported symptoms to pharmacy 4:28pm 10/5/17. First noticed bruising 10/4/17 when husband noticed her arm.
On 10-24-18 pt presented to the ED with a raised local reaction to his (R) deltoid region, it was raised and warm to the touch. Pt was treated with BENADRYL and an ice pack.
Patient was awakened in the night with left upper arm pain, redness and warmth. Pain worsened over the next 2 days and she was seen at clinic for evaluation on 10/31/2023. She rated her pain as a 7-8 out of 10 that was worse with ROM, pain was interfering with her ability to work and sleep. She was prescribed a Medrol Dosepak and Norco 7.5/325 for pain. She was seen ER on November first with c/o 10/10 pain in her left arm; she had a venous doppler US of her left arm, a CBC, CMP and EKG that were all found to be normal; she was prescribed Gabapentin to take in addition to the steroid and pain medications prescribed. As, of 11/3/2023 she was still experiencing sever pain in her arm; the redness had improved, but the arm continued to be warm
Day 9-13 arm red, slightly swollen at injection site. Now has faded. Topical Benadryl applied. Aspirin and oral Benadryl taken.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 06-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Information has been received from a 66 year old female pt. The pt's concurrent illness included osteoarthritis NOS, previously treated with Synvisc approximately ever 6 months. Past history included a knee arthroplasty 10-12 years ago. Therapy with Synvisc for osteoarthritis NOS included one 2mL injection every week for three weeks in the left knee in Jul-2000. Additional suspect medication included Flu Shield and Pnu Imune 23 vaccine. Therapy with Flu shield included one dose injection in the right arm on 10/14/2000. Therapy with Pnu Imune 23 vaccine included one dose injection in the left arm on 10/14/2000. The pt reported swellin gin bck of the knee (joint swelling) on 10/17/2000 and asked if there had been a Synvisc interaction with the flu or pneumonia vaccine. The left knee swelling is resolving. Additional information has been requested.
Rheumatoid arthritis flare up; Flu like symptoms; Total knee replacement; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296942-00 (Agency).  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) till 2022 at unk (citrate free) and second regimen subcutaneous since 28Feb2022 (ongoing) (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KNEE ARTHROPLASTY (medically significant) with onset 26Feb2022, outcome "not recovered", described as "Total knee replacement"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; INFLUENZA LIKE ILLNESS (medically significant), outcome "recovered", described as "Flu like symptoms". The action taken for adalimumab was dosage not changed.  Clinical course: The patient had flu like symptoms from the first Covid vaccine but not for the other two. She stopped medication for two weeks prior to surgery. On 26Feb2022, she had gone through knee replacement surgery. She stated that it was in the middle of an arthritis flare and possibly it was the result of stopping therapy. Her hands and feet were swollen and painful. She was getting back on therapy just now as of 28Feb2022. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient also received second and third (booster) doses of Pfizer Biontech Covid-19 Vaccine with intramuscular route of administration. HUMIRA (Solution for injection in pre-filled pen)(Adalimumab) administered subcutaneously for moderate to severe rheumatoid Arthritis. The reporter's causality for the event(s) of KNEE REPLACEMENT SURGERY and FLU LIKE SYMPTOMS with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare with Humira (Adalimumab) was a reasonable possibility. The causality as per reporter for Pfizer Biontech Covid-19 Vaccine (Tozinameran) was provided as possible for event flu like symptoms and causality for the events of total knee replacement and rheumatoid arthritis flare up were not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events influenza like illness cannot be totally excluded. Events total knee replacement and rheumatoid arthritis flare up are considered as intercurrent and assessed as not related to suspect product BNT162B2.
This spontaneous report was received from a nurse practitioner regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date in 2016 the patient was vaccinated with improperly stored ZOSTAVAX lot # M020071/expiration date-18-JUL-2017. No adverse event was reported. Temperature excursion of -5C, Time frame of 75 days as of 11-NOV-2016. There was no previous temperature excursion and call was not because of the data logger. The outcome of the event was unknown. No product quality complaint was involved. Additional information has been requested.
At 0915 she reported arm and finger tingling, chest and throat tightness, and heart racing. Took sips of water. Able to talk and hold conversation with nurses. At 0925 she reported that she had another "wave" of these symptoms which would quickly resolve. EMS called at 0930 because she had a third "wave" of these symptoms and stated that the tingling extended down into legs. Went to Medical Center at 0940 with EMS.
COVID-19 Breakthrough. I think my son had it first. I started feeling bad that Saturday. I had fever , chills, congestion, sore throat and cough. I also had watery eyes. I have also been experiencing a lot of fatigue. I lost my taste and smell capabilities about 3 days into my symptoms.
very stiff neck (day 1-2) and headache (day 2) lasting over 24 hours, extreme fatigue  & sleepiness (days 2-3), swelling  (day 2-present day) at the injection site longer than 5 days, low grade fever and chills (day 3), cold sore appeared on the right side corner of the mouth by April 4.   She was monitored at home. Given Tylenol for the headache, stiff neck, and fever. Given plenty of water when not asleep. For the cold sore looking effect, simple OTC cold sore topical medication
initially had fever, sore throat and body aches after 3 days felt a swelling in his neck and more drainage in his throat with swallowing but no shortness of breath
Pt accidentally given saline injection only. Pt was asked to come back to be revaccinated  the same day.
received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna vaccine on 28Apr2021 and has not gotten the second dose yet) had resolved.        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 product reported by reporter. No treatment medication reported by reporter. Patient want their second dose now but HCP wanted to know what the recommendation is since its been 84 days since the first dose.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up received, contain no new information.
No adverse event; Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received 0.2mL dose of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation.).    No concomitant medications was reported. Suspect product dosage text was reported as unknown. It was reported that 4 patients received 0.2mL doses of the presentation of the vial with the dark pink cap instead of the 0.25mL dose of the dark blue cap presentation. Doses were administered on 21-APR-2023 and 28-APR-2023. Each was administered as a second dose in the series. Patients ranged from 10m-5y old.  No treatment drug details was reported. This case contains information of 4th out of 4 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723264 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723264:Patient 1
No adverse effects reported; the patient was administered a dose of PNEUMO VAX 23 which was improperly stored; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.       On 31-OCT-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route were not reported; lot #: S026366, expiration date: 17-SEP-2020) for prophylaxis (product storage error). The vaccine experienced the following temperature excursion: below 2 degree Celsius: 1.1 Celsius (C) for 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. Outcome was reported as supported.
Pt c/o of tickle in throat followed by a cough. Pt reports lower back pain that radiates to lower limbs ; condition is chronic.
A report has been received from a Health Professional concerning a, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The patient experienced expired FLUMIST. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
expired ACTHIB was administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00818652) and transmitted to Sanofi on 19-Oct-2021.  This case involves a six-month-old female patient who vaccinated with third 0.5 mL (once) dose of expired HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ404AAB and expiry date 04-Oct-2021) via intramuscular route in the left thigh on 18-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This was the booster I received. Symptoms: Extreme fatigue and disorientation 20 hours after I received the injection. It resolved in 12 hours. I noticed some tenderness in my collarbone area about 48 hours after the injection. The supraclavicular lymph nodes are swollen on the left-side. The lump(s) are palpable on the surface and move around when pressure is exerted (pretty gross). It has been four days, and the area is still the same.
Pt recvd vax & devel pain inject site which lasted about 7 to 8 mins a/resolving; pt also c/o sore & heavy arm all day;
injection site became red, hot, hard by the next morning, and very sore. I let it go for a couple of days as those are all listed as possible side effects from having an injection. But by Thursday nothing had gotten better, so I drew a circle around the affected area with a marker to see if it was spreading and Friday morning it had spread about an inch and a half out of the circle. Given that this was four days after the injection, and I had had a similar problem with a tetanus booster (and had to receive IV antibiotics and was told I was now considered allergic to any future tetanus booster)  I went to the clinic to get it checked out. This time they were not sure if it was an infection or an allergic reaction, so they prescribed cephalexin and prednisone for about a week.