chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to a 14 year old patient of unknown gender. No concurrent condition and medical history was reported. On 12-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot # K006117, expiry date: 14-JAN-2017, intramuscularly in the left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Case number PHEH2014US013404 is an initial spontaneous report received from a pharmacist on 03 Jul 2014. This report refers to an 18-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number: X12104), subcutaneously on 02 Jul 2014. No adverse reaction was reported following this administration error.
Initial unsolicited report received from family nurse Practitioner on 21-FEB-2017. This case involves a three-month-old male patient (Age reported as four months) who was vaccinated with a dose of PENTACEL (batch number: C5249AA and expiry date: 27 Nov 2017) intramuscularly in right thigh, dose of HEP B (batch number: 443A2 and expiry date not reported ) intramuscularly in left thigh, PREVENAR 13 (batch number: N90908 and expiry date not reported) intramuscularly in right thigh and dose of ROTAVIRUS (batch number: M005732 and expiry date not reported) orally on 30 Jan 2017. The patient did not have any Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medication was not reported. On 30 Jan 2017, six hours following vaccination, the patient had a seizure lasting 30 seconds, lost consciousness; patient was shaking, and turned blue. It was reported that mother picked the child up and he was still trembling. On an unspecified date patient was taken to the emergency room. Diagnosis was reported as febrile seizure. Patient's mother had taken the temp at home and it was 100.3F. Other laboratory data and corrective treatment were not reported. On an unspecified date patient was recovered from events. Duration for seizure reported as 30 minutes. Upon internal review the case was considered as serious because of important medical event: febrile seizure. List of documents held by sender: none. Sender's Comments: This case concerns 4 month old male patient who received DIPHTHERIA/TETANUS/5HYBRID AC PERTUSSIS/IPV(MRC5)/HIB (PRP/T)VACCINE along with HEPATITIS B VACCINE, PNEUMOCOCCAL PLYSACCHARIDE VACCINE and ROTA VIRUS VACCINE. Patient developed febrile seizure. Time to onset is compatible with the role of vaccination. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case. Multiple vaccines administered simultaneously making it difficult to assess role of particular vaccine.
My daughter got the Moderna vaccination & she still got Omicron.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My daughter got the Moderna vaccination & she still got Omicron.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced COVID-19 (My daughter got the Moderna vaccination & she still got Omicron.). At the time of the report, COVID-19 (My daughter got the Moderna vaccination & she still got Omicron.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. Patient had unknown allergies. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Company Comment: This spontaneous case concerns a female patient of unknown age, with unknown medical history, who experienced the unexpected non-serious AESI of COVID-19, Omicron variant. The event occurred unknown number of days after receiving a dose of mRNA-1273 vaccine, dose number unknown. As reported, patient had a COVID positive test or diagnosis at an unknown date. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with unknown medical history, who experienced the unexpected non-serious AESI of COVID-19, Omicron variant. The event occurred unknown number of days after receiving a dose of mRNA-1273 vaccine, dose number unknown. As reported, patient had a COVID positive test or diagnosis at an unknown date. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt reported soreness in right deltoid area going down into right forearm with some tingling in her whole hand. Pt stated swelling around her right wrist which has been present before vaccine, possibly ganglion cyst.
Patient states that she is experiencing tiny red rashes all along the torso, the chest, and legs.
On 13th day after immune vaccine, forearm rash. On 14th day, spread to trunk, neck, legs, face. No buccal or oral lesions. Rash is vasculitic- blanches with compression.
Doses of the Moderna vaccine were administered after 12 hours since the vials was first used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of the Moderna vaccine were administered after 12 hours since the vials was first used) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of the Moderna vaccine were administered after 12 hours since the vials was first used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of the Moderna vaccine were administered after 12 hours since the vials was first used) 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.   Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received on 05-Aug-2021 and included non-significant information
pt recvd vax 10AM 22MAR95 & exp t014 R had sz @ 4AM 911 called taken to hosp ER-cold compresses-temp down to 101 R pt sent home w/parent-pt is playing & eating @ 11AM 23MAR95
tachycardiac; Low grade like a 99.8; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 17Dec2020 at single dose at the left deltoid for immunization. Medical history included tachycardia heart condition (had an underline heart condition that was a tachycardia heart condition). There were no concomitant medications.  Patient got Pfizer vaccine on 17Dec2020. Patient really had not had any side effects except had a low grade like a 99.8 yesterday (in Dec2020). Which was probably just the vaccine patient was assuming probably just the vaccine had to do like kid when they get in then they get a little fever. On 19Dec2020, though however patient had tachycardia. Like right now patient was in 130 and blood pressure didn't read when went to stand. And patient had drink plenty fluids all day on 18Dec2020. Patient previously did have an underline heart condition that was a tachycardia heart condition. Patient had not had any issues with heart for about. Because the last time had it was about 2 years ago. Patient had a cardiac condition that caused her to be tachy-cardiac. But it was usually only when she was pregnant. But patient was not pregnant and it had been about 2 years since last episode of this. And the only this that changed was this on 17Dec2020. So, this was the first time patient had had anything that changed after getting that vaccine. Patient did not take any medication. She used to be on a beta blocked but she was recently taken off of that (She don't know 3 months ago). Outcome of events was unknown.
3-5-02 left deltoid swollen cold compresses, 3/6/02 am swelling moved down towards elbow, cold and warm compresses Tylenol every hours, Advil, ice and heat, left arm bicep 9 inches right arm 7 ins, redness from top of deltoid to elbow's circumferential, swelling
10-15 minutes after injection, patient fell out of his desk, hitting his head on the way down. He was incontinent of urine and his body jerked before regaining consciousness. He was then alert and oriented. His mother arrived and transported him to clinic.
felt crappy; fatigued; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (felt crappy), FATIGUE (fatigued) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt crappy), FATIGUE (fatigued) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (felt crappy), FATIGUE (fatigued) and HEADACHE (headache) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reported no side effects after dose 1.  The next day after dose 2 the patient was fatigued, felt crappy and had a headache. It was stated that, events fatigued, and headache did not cause patient to seek medical care. Treatment medications were not provided.   This case was linked to MOD-2022-560438 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: The follow up information received contains no new information.
Low grade fever, fatigue, moderate abdominal pain/nauea, entire left side toes to head had mod-severe muscle and joint pain, headache for 3 days and gradually improved. Treated with tramadol and ketorolac. Other treatment: rest, warm packs to sore muscles and abdomen, and increased fluids.
24 hr after shot, got 1 X 1 inch red, raised area.  36 hr after shot, redness was lighter & more diffuse - 3 X 3 inch area, swelling and tenderness and hard area where shot was given.  A week after, it still looks like a line.
Warm red rash left of injection site. Patient states she felt a bump. Verified she did not bump into any object.
face itching   Narrative: 03/17/2021 ADDENDUM STATUS: COMPLETED S/O: reported L face itching while in the monitoring area after his 2nd Pfizer Covid vaccination. His VS as follows: 15:40 BP 11/76 HR 75 15:55 BP 135/78 HR 71 Provided juice and crackers Patient reports itching is going away at end of monitoring period. A:Patient with stable VS and reduction in facial itching s/p 2nd Pfizer Covid vaccination. P: Patient released from monitoring area as s/sx were resolving. /es/ Signed 03/17/2021 12:49
Initial solicited report received on 08 June 2016 from a consumer participating in the below-mentioned study. This case involves a 26-year-old male, who received a dose of FLUZONE Intradermal (site of administration and batch number not reported). On an unknown date after receiving a dose of FLUZONE Intradermal (site of administration and batch number not reported), the subject had severe muscle weakness. The outcome of event severe muscle weakness was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
He lost feeling in his entire arm.; He had complete numbness in his arm; Later in the day he got tingling and then had feeling back in his arm and hands; This is a spontaneous report from a contactable consumer (patients wife). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 57-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications. On an unspecified date, the patient had a reaction at the site and they kept him there to monitor him. He lost feeling in his entire arm. He had complete numbness in his arm. Later in the day he got tingling and then had feeling back in his arm and hands. Outcome of the events are reported as unknown at this point of time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A couple of weeks after the vaccine, I experienced accelerated heartbeat. I have been fatigued. I am having a stabbing, sharp pain in my chest that has been ruled out by having blood work. My heartrate went to 105 just sitting. This occasional happens often. I went to my doctor. I went to a cardiologist and had an EKG, echocardiogram and Holter monitor. I went to a cardiologist and still going through tests with a cardiac catherization. Heart attack has been ruled out.
As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my body was on fire. Also add headache could not hardly stand to lay my head on the pillow. About 4 AM I could not tolerate the situation any longer and took 600 mg of Tylenol. After that was able to rest some. The next day after the vaccination my joints were achy moderately and I have a headache. The injection site was tender to the touch and arm range of motion decreased and arm sore. Took 400 ibuprofen about 4 PM day after injection to ease Reactions
Patient admitted to Hospital on 8/31/2021 for Shortness of Breath. Patient in ER now, on supplemental oxygen and will be admitted to hospital.
Patient reported pain in the arm where she got the shot. She said the pain is radiating from shoulder to elbow and sometimes to wrist. She also stated that the pain is deep inside the arm.
Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around 10pm). Still felt a slight headache the next morning (5:30am) and took two more tablets. Felt fine after that. I felt kind of cold during the evening, but by the time I went to bed around 10pm, that was when the chills had hit full force. I could not get warm enough. I continued to increase the temperature of  my electric blanket and was not comfortable until I was at a 6 out of 10. When I woke up the next morning the chills were gone. Also experienced soreness in the left arm.
Early January: Extreme weight loss Extreme dry mouth constant thirst Frequent urination  Late January: DKA unconsciousness Glucose 861 A1C: 16.8 Diagnosed Type 1 Diabetic Insulin Dependent
Fever; Body aches; Chills; Tremors; Headache; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 32-year-old male patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date: unknown), intramuscular in the left arm, on 12Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included Sleep apnea, asthma, gastrooesophageal reflux disease (GERD), hypertension and anxiety. The patient did not have COVID-19 prior to vaccination. The patient had no known allergies. Historical vaccines included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), via an unspecified route of administration in the left arm, on 29Dec2020 for immunization; and the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date: unknown), intramuscular in the left arm, on 21Dec2020 15:15, for COVID-19 immunization. The patient experienced fever, body aches, chills, tremors and headache on 12Jan2021 23:00. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
No adverse effects reported.; the "14 year old" patient inadvertently received a dose of PROQUAD on 5/18/2020.; This spontaneous report was received from a medical assistant referring to a 14 years old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 18-MAY-2020, the patient inadvertently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot # S027463, has been verified to be a valid lot number, expiration date was reported as 22-MAR-2021, but upon internal validation established as 02-MAR-2021, strength, dose and route were not reported) for prophylaxis with Merck sterile diluent (batch/lot# and expiration date were unknown) (inappropriate age at vaccine administration). No adverse effects reported.
I received the vaccine in my left arm and noticed the pain in my left arm and armpit the day after receiving the shot. 2 days after receiving the shot, I noticed the swelling of my left lymph node in my left armpit. It was very painful to move my arm or leave my arm resting in a normal position since it would put pressure on my lymph node. I had very limited mobility on days 2,3 and 4 after the vaccine but quickly improved starting day 5 with very minimal pain. I had a video call with a doctor who recommended 800mg of ibuprofen every 8 hours & warm compress on the lymph node. In general, I had very minimal symptoms from the first vaccine except the lymph node swelling & pain. Starting day 5 post vaccine I was basically back to normal & have felt good ever since.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 15-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Jun2021 as dose 1, single (Lot number: EW0180), on 09Jul2021 as dose 2, single (Lot number: EW0196) and on 17Jan2022 as dose 3 (booster), single (Lot number: 33036BD) at the age of 14 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01May2022, outcome "unknown", COVID-19 (medically significant) with onset 01May2022, outcome "recovering" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course included no other vaccines in four weeks and No other medications in two weeks. No known allergies.
I had just resolved moderate reaction to a wasp sting that caused significant swelling, redness, burning, etc. and required Prednisone and constant Benadryl for 4 days. That night the site of the wasp sting began itching and mild swelling; resolved approx. 18 hours after injection.
hoarse throat; sore throat; feels like "Junk"; swollen lymph nodes in her throat and neck; little bit of rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash) and FATIGUE (fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in her throat and neck). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, THROAT IRRITATION (hoarse throat), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (feels like "Junk"), RASH (little bit of rash), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes in her throat and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not have any difficulty breathing and she felt "junk".
Information has been received from a Registered Nurse concerning a male in his 70's who was vaccinated with Pneumovax 23. Concomitant therapy included warfarin sodium (Coumadin) and influenza virus vaccine (unspecified). Subsequently the patient experienced a swollen and red arm. The patient went to the ER twice and it was not known whether he was admitted into the hospital. The patient was treated with IV antibiotics. As of 07-NOV-2007, the patient had recovered. The nurse felt that this was an other important medical event. Additional information has been requested.
He cannot breath; sick; pain; bones are aching; aching joints; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (He cannot breath), ILLNESS (sick), PAIN (pain), BONE PAIN (bones are aching) and ARTHRALGIA (aching joints) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (He cannot breath), ILLNESS (sick), PAIN (pain), BONE PAIN (bones are aching) and ARTHRALGIA (aching joints). The patient was treated with OXYGEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (He cannot breath), ILLNESS (sick), PAIN (pain), BONE PAIN (bones are aching) and ARTHRALGIA (aching joints) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 09-SEP-2021 contains NNI. On 09-Nov-2021: Non significant follow up received
Blood pressure went sky high. Shortness of breath. Retaining water. Kidney problems oxygen dropped. Wheezing.