chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received the Pfizer COVID vaccine (lot#FK1527) in the L deltoid and the Fluarix Quadrivalent Influenza Vaccine (Lot#3NA4M) in the R deltoid at approximately 1050 from vaccinator RN. After the client received both vaccines, he stood up to wait next to his mother who was receiving her COVID vaccine from the same vaccinator. Due to a limited supply of chairs at the mobile event there was not an available chair to allow the client to sit down while waiting with his mother. At approximately 1055, as the client was standing next to his mother, he began to slouch over the vaccination table and vaccinator RN's assisted client to the ground. Client lost consciousness for approximately 2 seconds. RN assessed non obstructed airway, no respiratory distress, and raised the client's legs while he was laying on the floor. RN assessed client who presented with mild pallor of the face, no diaphoresis, and pupils equal and reactive. RN took client vitals at 1103 with BP 100/60 in the L arm laying down, 70 HR, and 16 RR. Lead RN assessed client at 1103 presented A&O x4 and talking in full sentences,  grip strong and equal, cap refill < 3 seconds, and skin pink and warm to touch.  Client's mother reported that the client ate breakfast at 0830 and had a muffin. Client denied dizziness, SOB, headache, numbness, or tingling. Client was assisted to zero-gravity chair and Lead RN advised that the client be observed for 30 minutes. Client's father reported that he has a history of fainting but reported that the client has never fainted in the past. Lead RN provided client with water, juice, and graham crackers. Client took sips of the water and juice and ate his snacks. Client reported to Lead RN that he was "feeling good now" and denied any dizziness, SOB, headache, numbness, or tingling. RN reviewed when to f/u with PCP. At 1140 the client left the vaccine site with his parents. Client walked out of the vaccine site with a steady and symmetrical gait.
Information has been received from a nursing student concerning her 4 year old daughter who on 22-JUL-2005 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) 0.5 ml (Lot number not reported).  On 21-AUG-2008 she was vaccinated with a second dose of VARIVAX (Oka/Merck) (Lot #654130/0920F) which had expired on 27-JUL-2008.  The patient also received MMR II (MSD), DTAP (manufacturer unknown) and (Vero)  IPOL on the same date.  On 21-AUG-2008, the patient complained her leg hurt and later developed a fever.  On 22-Aug-2008, the patient recovered.  The patient sought medical attention from her mother.  There was no product quality complaint.   Additional information has been requested.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4377125-00. A 24-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 24 years intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unknown (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "rheumatoid arthritis flare up". The action taken for adalimumab was unknown. Clinical Course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter considered "rheumatoid arthritis flare up" related to BNT162b2. The reporter's causality for the event of rheumatoid arthritis flare up with HUMIRA (ADALIMUMAB) was no reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
2-3 days of feeling heaviness on the left arm, pain, swelling, and low fever.   A couple of weeks afterward, pain on the upper back area, tingling on the arm down to the fingers.
experiencing colds; head was stuffy; This is a spontaneous report from a contactable consumer (patient) to report from a Pfizer sponsored program.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the second dose was due for tomorrow but currently (as reported) the patient experiencing colds and head was stuffy on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
4 days after receiving oral vaccine, started having increased fussiness and bloody stools. Self resolved after 2 days.
Pain in arm, chest and whole body, went to emergency center was told she may have had a heart attack
Member in observation approx 10 mins after receiving vaccine became diaphoretic with complaints of nausea,.  Member then began to vomit x 2.
4 year old received Moderna COVID-19 Vaccine Bivalent Booster, dark pink cap, 6m-5y
Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the second dose; 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 PRODUCT DOSE OMISSION ISSUE (Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the second dose) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past 35 days for second dose/patient received the 1st dose of the vaccine in March and they are wondering about the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
A few hours after vaccination infant developed hives on stomach, chest, arms, legs, and back. Within an hour of initial onset, hives spread to infant's face. Parent contacted on call pediatrician who advised to monitor for other symptoms of an allergic reaction. No other symptoms were apparent. Hives were gone by the next morning, February 21, 2017.
surgery; blood transfusion; This spontaneous case was reported by a pharmacist and describes the occurrence of SURGERY (surgery) and TRANSFUSION (blood transfusion) 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 SURGERY (surgery) and TRANSFUSION (blood transfusion). At the time of the report, SURGERY (surgery) and TRANSFUSION (blood transfusion) outcome was unknown. Not Provided      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.
Patient called me late on 6/6/14 with pain in the arm with injection. Instructed her to take APAP and call me the next day. She came in to see me with pain and numbness in the fingers. Told her to give it one more day.
This case meets vaccine breakthrough criteria.  SXS SOB, SORE THROAT, RUNNING NOSE, BODY ACHES, FEVER
Felt feverish the morning following the shot (about 24 hours later). Just really cold and could not get warm. Decided to take my temperature expecting a high one and it read 94.8. Thought maybe something was wrong with my thermometer and decided to try another one I had in the house. Read 95.0. Temperature stayed super low for about 4 hours (from about 0800 to 1200) and then finally went above 96 again. By that evening it was 97.8 which is pretty normal for me.   I also had a swollen/puffy armpit on the right side (shot side) of my body for 10 days following the vaccine.
Patient arrived to County joint mass vaccine event. After vaccine was given patient told administrator that she had received the Moderna vaccine 3 weeks earlier. Came to this event as she didn't want to return to previous county for second Moderna vaccine.
1st injection - large, tender, red, swollen lump on arm lasting approximately 5 days. Pain treated with tylenol.   2nd injection - 99.5-102.0 fever, chills, sensitive skin, fatigue, headache lasting about 48 hours. Symptoms treated with tylenol and ibuprofen. Asymptomatic after 48 hour window.
Approximately one month after treatment, round lump the size of a marble appeared at vaccination site. It is not red and is not painful. Still persists as of 9/22/20.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Tiredness; Pain at injection site; Low grade fever; Pain in upper arm; Swollen left arm pit lymph nodes; Tenderness in left side of neck; Dose 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 13:00 (Lot number: FE3592) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "adult ADD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; ALEVE; LORATADINE. Past drug history included: Ephedrine, reaction(s): "known allergies: ephedrine", notes: known allergies: ephedrine/ pseudoephedrine; Pseudoephedrine, reaction(s): "known allergies: pseudoephedrine", notes: known allergies: ephedrine/ pseudoephedrine. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021, when the patient was 68 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 03Feb2021, when the patient was 68 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 13:00, outcome "unknown", described as "Dose 3"; FATIGUE (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Tiredness"; VACCINATION SITE PAIN (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Pain at injection site"; PYREXIA (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Low grade fever"; PAIN IN EXTREMITY (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Pain in upper arm"; LYMPHADENOPATHY (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Swollen left arm pit lymph nodes"; TENDERNESS (non-serious) with onset 25Nov2021 12:00, outcome "recovering", described as "Tenderness in left side of neck". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of fatigue, vaccination site pain, pyrexia, pain in extremity, lymphadenopathy, tenderness.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Treatment included:Naproxen, rest, warm packs applied to pain sites. concomitant therapy included multivitamin.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 14-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
chills-6 to 24 hours after vaccine fevers (Tm 101.6 F)-12-24 hours after vaccine myalgias-6 to 24 hours after vaccine
Had severe back pain right away Stayed in store felt better We called her doctor and talked to her. She was instructed if it became worse to go to the er which was 2 minutes down the street.
Patient broke out in rash around and below injection site, claimed rash was itchy and warm to the touch. doctor prescribed triamcinolone cream
FRIDAY 2/5: FATIGUE, SORE THROAT, NASAL CONGESTION, BODY ACHES, PAIN ON INJECTION AREA, CHILLS AND FEVER. TEMPERATURE 7PM:38.1 C (TOOK TYLENOL), 9PM:37.7 C, 10PM:37.4C SATURDAY 2/6:NASAL CONGESTION, COUGH, MINOR FATIGUE, MINOR PAIN ON INJECTION AREA. TEMPERATURE ALL DAY 37.1 C. TOOK TYLENOL AT NIGHT FOR THE THROAT PAIN.  SUNDAY 2/7: MASAL CONGESTION, COUGH, MINOR FATIGUE, LOSS OF TASTE AND SMELL. BODY TEMPERATURE ALL DAY: 36.8 C.  MONDAY 2/8: COUGH (DRY-ISH), MINOR NASAL CONGESTION, SENSE OF TASTE IS BETTER, SENSE OF SMELL COMES AND GOES AT TIMES.  BODY TEMPERATURE 37.2 C.
One of three pts who exp dizziness, faintness, profuse sweating & was very shaky w/in 5 min following immun; recovered spontaneously;
This spontaneous report as received from a Nurse Practitioner refers to a 12 month old female patient developmentally delayed. The patient's medical history included left sided weakness and constipation. Nurse practitioner confirmed that all medical history developed on unspecified dates prior to receiving M-M-R II, VAQTA, VARIVAX (Merck) and PREVNAR (manufacturer unknown). None drug reactions/allergies were reported. On 05-JAN-2015, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneous, lot # K001997, expiry date 10-FEB-2016. Other suspect therapies included dose of VAQTA 0.5 ml, intramuscular, lot # K005958, expiry date 09-FEB-2017, dose of VARIVAX (Merck) 0.5 ml, subcutaneous, lot number K009757 and expiry date 09-JUL-2016 and a dose of PREVNAR (manufacturer unknown) dose, route, lot number and expiry date were not reported. None concomitant medication provided. The nurse practitioner stated that the patient developed a fever of 103.3f and a heart rate of 189 "within 20 hours" of receiving M-M-R II, VAQTA, VARIVAX (Merck) and PREVNAR (manufacturer) on 05-JAN-2015. The nurse practitioner reported that she saw the patient in the office "this morning" (on 06-JAN-2015) and the patient's temperature was 101/3 F and her heart rate was 178. The nurse practitioner stated that she referred the patient today to an unspecified hospital to have "routine lab work drawn", a chest x-ray, and an electrocardiogram (EKG). The nurse practitioner reported that the patient was in route to the hospital at this time to have the above tests done. The patient had not been admitted to the hospital yet. On 07-JAN-2015, the Nurse practitioner reported that the patient was still in an unspecified emergency room since yesterday but has not been admitted yet. At the time of the report the patient did not receive any treatment. The outcome of patient developed a fever of 103.3 F was reported as not recovered. Relatedness between the therapy with M-M-R II, VAQTA and VARIVAX (Merck) and the event: fever of 103.3 F was not reported. Additional information has been requested.
The patient returned to the pharmacy today to report that she was having shoulder/upper arm pain since the day after vaccination. She had not, as of today, visited a doctor/clinic to be checked out. I recommended she be seen by a doctor for symptom resolution.
pt. felt dizzy after receiving her vaccine, pt. went to stand and was assisted to the ground for vitals
There are no adverse events, yet, but after we administered the Moderna vaccine, his daughter-in-law called & told us that he already go the Johnson & Johnson COVID-19 vaccine.
Body Rash Itchiness; red rash; Flu-like Symptoms; Runny Nose; Dizziness; Lack of Appetite; Upset Stomach; Weakness; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness. On an unknown date, the outcome of the itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash, influenza-like symptoms, runny nose, dizziness, appetite absent, upset stomach and weakness to be related to Shingrix.  Additional details were provided as follows: The patient reported a rash at the injection site that started with three small red bumps, as well as a red streak near the injection site. The patient also reported that 8 hours after the injection the rash, like small red bumps, spread from her bottom, to her back, up to her hairline. The rash at the injection site and on her body, was itchy. None of the patient's symptoms have resolved. The reporter gave consent to follow up.
Vaccine 18 Oct and 2nd 2 wks later. Symptoms 11/13/02=SOB and increased heat rate. Pt sent for full work up. Dia: anxiety. Pt did have similar sx's one year prior. Feels better but not 100%.
After 2 weeks I still have deep muscle pain and cannot raise my arm without extreme sharp pain.
Patient first diagnosed with Covid infection on 5/19. Patient was seen in the emergency department on 5/28 generally feeling unwell with generalized weakness. Subsequently admitted from 5/28-6/8 for weakness and Covid.  This meets criteria for vaccine breakthrough case review.
Pain and ringing in both of my ears started a few hours after the test. I have never had ringing in the ears of any sort.  Ringing has continued for going on three weeks - no relief.  Saw a doctor.  Prescribed a dose of Prednisone.  No relief at this point - ring continues 24 hours a day
Dizziness, She began going sideways and had to hold on to the counter, which scared her; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, She began going sideways and had to hold on to the counter, which scared her) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033621A) for COVID-19 vaccination.     Concomitant products included OXYGEN for an unknown indication.    On 17-Jun-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 18-Jun-2021, the patient experienced DIZZINESS (Dizziness, She began going sideways and had to hold on to the counter, which scared her). On 18-Jun-2021, DIZZINESS (Dizziness, She began going sideways and had to hold on to the counter, which scared her) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Developed painful shingles rash after receiving vaccine.  Symptoms included pain , blisters , and oozing fluid
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 16-JUL-2013 the patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route, lot number and thimerosal status were not reported), and on 01-OCT-2013 the patient was vaccinated with the second dose of RECOMBIVAX HB inj 10 (dose, route, lot number and thimerosal status were not reported). No adverse symptoms reported. Additional information has been requested.
Had a eye infection; sore right arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE INFECTION (Had a eye infection) and PAIN IN EXTREMITY (sore right arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, Urinary incontinence and Dyspepsia. Concomitant products included OMEPRAZOLE for Heartburn and GERD, SOLIFENACIN for Urinary incontinence.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On an unknown date, the patient experienced EYE INFECTION (Had a eye infection). The patient was treated with MOXIFLOXACIN for Eye infection, at a dose of UNK dosage form, tid. At the time of the report, EYE INFECTION (Had a eye infection) had not resolved and PAIN IN EXTREMITY (sore right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that sore right arm recovered in 1-2 days. Treatment for the events included moxifloxacin and steroids   This case was linked to US-MODERNATX, INC.-MOD-2021-138797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional information received on 17-May-2021, events, concomitant medications and lot number updated.