chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Confirmed COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Confirmed COVID-19 infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 07-Apr-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) at an unspecified dose. On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Confirmed COVID-19 infection). At the time of the report, COVID-19 (Confirmed COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided.  No treatment information was provided.  Company Comment: This spontaneous case concerns a patient, of unknown age and gender, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of a dose of the Janssen COVID-19 vaccine on 07Apr2021 and the booster dose of the Moderna mRNA-1273 vaccine on 25Oct2021. On 16Dec2021, the patient tested positive for the COVID-19 virus. On an unspecified date, it was reported that the patient experienced a mild case with congestion, headache and mild fever. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Non-significant information received.; Sender's Comments: This spontaneous case concerns a patient, of unknown age and gender, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of a dose of the Janssen COVID-19 vaccine on 07Apr2021 and the booster dose of the Moderna mRNA-1273 vaccine on 25Oct2021. On 16Dec2021, the patient tested positive for the COVID-19 virus. On an unspecified date, it was reported that the patient experienced a mild case with congestion, headache and mild fever. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
Metallic taste in mouth that started about five minutes post vaccination; persisted for about two hours post vaccination. Facial and hand swelling started two hours post vaccination, persisted for 24 hours after; itchy throat started at two hours after, persisted for about eight hours after vaccination.  18 hours post vaccination, severe headache and moderate nausea set in, both lasted for another 18 hours (36 hours post vaccination). Mild myalgias and nausea at 48 hours pat vaccination.
Woke up to sneezing and later in afternoon pain & burning in bladder. Will need to call doctor to get an antibiotic possible bladder infection.
(MODERNA COVID 19 VACCINE EUA)   Unknown, tried contacting patient back multiple times but was unsuccessful
This is a spontaneous report received from a contactable consumer (mother) reported for a daughter. A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided), dose 1 via an unspecified route of administration on an unspecified date in Aug2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller states her daughter had her yearly immunizations on Monday and has been running a fever/temperature on Aug2021 and her paediatrician said to wait a week to get her COVID vaccine. Caller states her daughter already had her first dose, and the family doctor told them to wait a week to initiate the second dose. Caller asks what vaccination provider to call to speak to Referred to call local health department for the information. Outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient is a 9 year old male who received the Pfizer covid-19 12+ dose instead of the correct 5-11 dose. This resulted in the patient receiving 30mcg of the Pfizer vaccine instead of 10mcg. Patient was observed for an hour in the clinic and did not have any adverse reactions.
Patient states night before shot she was bitten by noceum bugs outdoors . She recieved the shot the next day and itching intensified that evening. Days later she states her arms were so red and inflamed she had to ice them .  6-7 days later. She finally took benadryl 25 mg and the reaction started to subside. She then called us at the pharmacy and wanted it reported
body aches; head aches; sting on the hand's veins; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (head aches) and VACCINATION SITE PAIN (sting on the hand's veins) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Hypercholesterolemia.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), HEADACHE (head aches) and VACCINATION SITE PAIN (sting on the hand's veins). The patient was treated with NAPROXEN at a dose of 500 milligram. At the time of the report, PAIN (body aches), HEADACHE (head aches) and VACCINATION SITE PAIN (sting on the hand's veins) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: super high (High) super high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Difficulty swallowing, extremely painful sore throat, swollen, painful red tongue with bumps, swollen throat.
Information has been received from a 73 year old female consumer with a sulfonamide allergy and a history of shingles who on 05-OCT-2006 was vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. Subsequently "a few days" after getting the vaccine she developed a "really bad rash." As of 24-OCT-2006 the patient had not recovered. Medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Patient is 18 year old male who received his first dose of Pfizer COVID 19 vaccine.  graduate intern, administered the dose and within the first minute, patient tensed up and passed out.  He appeared to look like he had a seizure.  Patient was passed out for less than a minute.  When he came to, he said he fell asleep.  He said he felt warm.  We checked his Blood pressure and it 94/62 and pulse was 54.  We called 911 and laid patient on a mat.  He was given gatorade and a warm wash cloth.  Paramedics arrived and rechecked BP.  It was 110/66 and pulse was 66.  They evaluated him and told him to have someone drive him home.  Patient has not history of seizures and no history of adverse reaction to vaccine.  He did receive a tetanus booster on 5/17/21.  Only other medical history is asthma.  He uses albuterol prn but has not had to use it for > 4 years.
Location: arms (left deltoid area); Quality: itchy (a little); painful; red; Duration: has noted for <1 week; started a couple hours after the 3 vaccines were given on 10/17; Onset/Timing: abrupt onset;   Context: MCV4, Flu and Tdap given at site; Alleviating Factors: Tylenol given; Associated Symptoms: no fever; Notes: Was worse yesterday and first thing this morning. Feels better now per patient; Local reaction to vaccine, left arm. Cool compresses to area and Ibuprofen as needed for discomfort. Monitor for increased redness, fever or spreading of redness. Benadryl as needed for itching.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/the last dose; titer result was neg;
Stroke, Right distal M1 middle cerebral artery occlusion.  Transfermoral cerebral angiography and intra-arterial thrombectomy of right middle cerebral artery clot.  Complete recanalization of the primary occlusion.
Pain at injection site the next day on 01/28/21 the pain moved to pt shoulder then over time the pain went to her neck,left side of her face and has been on going since
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant drugs were not reported.  It was reported that there was a dark blue cap vial with a dose of 25 mcg for age group 6 months to 5 years instead patient was administered with 10 mcg dosage from the dark pink cap and a label with a yellow box.  Treatment medications were not provided.  This case was reported for patient 10 Out of 18(12 Patients-Initial Dose).   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
12:00  23 yo female c/o  dizziness, nausea while she was closely observed by EMS at the post vaccination area.  1230:  c/o dizziness, nausea.  Transfer the patient to stretcher. Alert & Oriented x 3.  Pt was diaphoretic, c/o constant nausea, headache. 1240: Peripheral Pulse- weak.  P 82. Oxygen sat 98. 1300: c/o constant nausea, headache, stated having swollen tongue. Facial flushing. Epiphen injected in Rt thigh. 13:15  Called 911 to transfer the patient to Medical Center BP 158/110, P110, R 20, O2 Sat 98%
Implanted defibrillator detected ventricular tachycardia and shocked me 19 times. Admitted to the ICU.
Pt vaccinated with MR developed joint pain. Called private MD advised to take Advil & use heat to joints. Symptoms lasted for 2-3 days.
This spontaneous report as received from a health worker refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in March 2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 lot # L020015 expiration date: 16-AUG-2017 (dose, site and route of administration were not reported). There was no adverse effects reported. It was stated that the vaccine underwent a temperature excursion of 31 Fahrenheit for an unspecified time frame. In reference to previous excursions the reporting nurse stated that excursions showed minimum reached 31 Fahrenheit on several days starting March 2016 in to April 2016. This is one of several report received from the same reporter. Additional information has been requested.
received the vaccine and got shingles after/suspected vaccination failure; very very painful; rub my skin so hard; received the vaccine and got shingles after; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: received the vaccine and got shingles after/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: received the vaccine and got shingles after), pain (Verbatim: very very painful) and chafed skin (Verbatim: rub my skin so hard). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 2 years) and the outcome of the pain and chafed skin were resolving.   The reporter considered the vaccination failure, shingles, pain and chafed skin to be possibly related to Shingles vaccine.     The company considered the vaccination failure, shingles, pain and chafed skin to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 31-May-2023 The case was received from the patient via interactive digital media. In the last 5 years as soon as she got the shingles shot and recently got shingles. The patient stated that they were very very painful and lasted almost 2 years. The patient rub her skin so hard that her body would bleed there was really nothing for shingles and she was in recovery so it would not take any painkillers. The patient believed that the medicine was not the alternative. The patient  prayed that you get better it was a tough road but eventually you did get better. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain). At the time of the report, INFLUENZA LIKE ILLNESS (I had mild flu like symptoms), RASH PRURITIC (Itching), BURNING SENSATION (Burning) and RASH (Within 24 hours of the Moderna vaccine I broke out in the most awful body rash with stabbing pain) had resolved.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were provided by reporter. The rash finally stopped after taking an antibiotic.
Shot was administered at 11:30 a.m. At 3:30 p.m. my left upper arm experienced intense pain.  The pain came on IMMEDIATELY and SEVERELY.  The muscle has been frozen and pain has been experienced since.  Now it is Tuesday 11/12/02 and the area is tender touch, still frozen in movement and pain is still severe.  A doctor has been called today, 11/12/02, and a visit is scheduled for 2:45 p.m. this afternoon. The follow up states adverse reaction-pain, and lack of mobility. 11/8/02 the pain is gone and mobility returned after use of ibuprofen andmuscle relaxent for several weeks 12/16/02. There was no adverse reaction where the influenza vaccine was administered.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 24Feb2021 at 14:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 25Feb2021, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event sore arm was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Guillain Barre Syndrome; 7/18/21 gabapentin started 7/19/21  IVIG (Privigen) 30g IV for total of 5 days 7/20/21  symptoms worse 7/21/21 -7/23/21 symptoms gradually improved 7/24/21 Patient is doing better. Strength continues to improve. Tingling in feet resolved. Minimal in fingers. No other complaints. discharged from hospital.
Mom states baby had a high pitched cry lasting greater than 3 hours. Baby also had vomiting and refused to eat.
loss of taste; short of breath; body aches; loss of appetite; Night sweats; burning muscles; tired; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received bnt162b2, (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 22May2021 at 13:15 (at the age of 48-year-old) in right arm as dose number unknown, single for covid-19 immunisation. The patient medical history included COVID long hauler, ptsd, shoulder surgery in November and COVID-19. Concomitant medication(s) included vitamin d nos (VITAMIN D NOS); vitamin b [vitamin b nos] (VITAMIN B [VITAMIN B NOS]); calcium (CALCIUM); duloxetine (DULOXETINE); alprazolam (XANAX) and multi vit (MANUFACTURER UNKNOWN) taken for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID prior vaccination, the patient was diagnosed with COVID-19. Not tested for COVID post vaccination. On 23May2021 02:00, the patient experienced night sweats, body aches/burning muscles, tired, loss of appetite, short of breath and loss of taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The clinical outcome of the events were not recovered.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].
Syncope & collapse in clinic as walking out the door, child also vomited. Child stabilized and released. Child also was pale in appearance. Child also has blood test drawn for lead and anemia at about same time as vaccination.
Burning arm, warm sensation all over body, got weak and sat down. Taken to the ED and put on observation and later released.
COVID test result Positive; COVID test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) and on 16Mar2022 at 15:00 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient had no relevant medical history or known allergies. There were no concomitant medications or other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID test result Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. The facility where the most recent vaccine was administered was other. The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination. The patient had tested for COVID-19 post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hives on back 3 hours after injection. Pt taking 50mg of diphenhydramine and following up w/PCP in AM.
The Moderna covid vaccination was given to an underage patient. Patient was 13 years old at time of vaccination. No adverse reaction noted.
Patient complained for pain and inflammation and redness on 11/17. Patient went to clinic on 1/18 then proceeded to a urgent care. At urgent care she was diagnosed with cellulitis and prescribed Bactrim. Patient came in at 4:50 pm to report her complaints.
chills; nausea; low grade fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), PYREXIA (low grade fever) and FATIGUE (fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 043L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), PYREXIA (low grade fever) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), NAUSEA (nausea), PYREXIA (low grade fever) and FATIGUE (fatigue) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-021571 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-021571:
Right thigh - 2.5x4.5cm mild erythema. Left thigh - some swelling, slight tenderness, barely warm.
ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT, UNSPECIFIED VEIN
Pt as admitted to the hospital with severe b/l pneumonia and hypoxia requiring high flow oxygen on 4/10/2021. He received his 2nd covid vaccination on 4/4/2021 and began to have shortness of breath 3 days later. He is still hospitalized with severe pneumonia as of 4/14/2021 and his condition has progressed to left upper lobe collapse which will require a pulmonary interventionalist as out pt.