chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine was administered on the 38th day; Moderna vaccine was administered 8 days beyond its expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered 8 days beyond its expiration) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 024C21A) for COVID-19 vaccination.     The patient's medical history was not provided. The patient had no known allergies.    On 09-Jun-2021 at 8:31 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021 at 11:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered 8 days beyond its expiration). On 07-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine was administered on the 38th day) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered 8 days beyond its expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up document received  contains no new information.
Horribe headache starting at 1150 pm. Headache lasted until aug 21. Felt sick and tired...Nonstop post nasal drip. Tight chest. Cough non stop.  Aug 28 started coughing up yellow mucus.
How long side effects last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long side effects last) 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 VACCINATION COMPLICATION (How long side effects last). At the time of the report, VACCINATION COMPLICATION (How long side effects last) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products reported.  No treatment products reported.
I just worried about if I have like that the a Myocarditis; I have like the pain on the left side of my chest pain and all the way penetrates to the back; I got the sore pain after like the 2 days gone; I have like the pain on the left side of my chest pain and all the way penetrates to the back; I have like the pain on the left side of my chest pain and all the way penetrates to the back; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiry date: unknown) dose 1 via an unspecified route of administration on 08Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, "I just had the first shot of Pfizer on 08Jun2021 and 3 or 4 days after and I had chest pain on the left side and all the way penetrates to the back. So it's like a pressure pain and but up to now I still had the pain but not as much like 2 or 3 days before. I just worried about Myocarditis. I just want to make sure, that my heart is ok on an unspecified date in Jun2021." The outcome of events i have like the pain on the left side of my chest pain and all the way penetrates to the back is not recovered and for the other events it was unknown.  Information about lot/Batch number has been requested.
50 minutes after shot, about 6:20 pm, my throat started to swell. My hands and wrists swelled. My skin got splotchy. Both of my arms started to itch. I took two Benadryl when I got home at 6:40 and the symptoms went away about 40 minutes later.
I received two doses of the Pfizer BioNTech COVID-19 vaccine via my employer.  The first dose was administered on 20 May 2021 and the second dose on 10 June 2021.  I then presented with significant swelling and redness on both feet in approximately August 2021.  After the symptoms persisted for several weeks I visited my primary care practitioner in October 2021.  Her initial conclusion was that my symptoms were consistent with psoriasis, and recommended I consult a dermatologist.  In November 2021 a dermatologist confirmed the psoriasis diagnosis, noting that the instances of psoriasis had spread beyond my feet to my arms and legs.  The dermatologist began a course of topical steroids.  While the steroids provided temporary relief, use did not provide long term resolution of my psoriasis, which has become increasing worse over time.  I m a healthy adult male with no history of serious illness, no family history of psoriasis, and I had no significant health incidents in 2021 other than receiving the vaccination.  There are several scientific papers published indicating a relationship between COVID-19 vaccination and the development of adult onset plaque psoriasis.  I consider this event to be permanent damage due to the inability to cure psoriasis.
3 day history, starting on 15JUN2013, of multiple round, pruritic, erythematous, raised lesions on front of chest and abdomen. Lesions are all at the same stage.
Information has been received from a licensed practical nurse concerning an 82 year old male patient with chronic obstructive pulmonary disease, hypertension, congestive cardiac failure, and coronary artery disease and a history of renal cancer and nephrectomy (in 2006) who on 15-NOV-2007 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot #658395/0966U).  The patient took other unspecified medications.  On 11-May-2009 the patient was seen in the office for shingles to the right side of the chest.  The nurse reported the lesions were "high blisters and pretty severe".  At time of reporting, the patient did not recover.  The patient sought unspecified medical attention.  Additional information has been requested.
POSSIBLE STROKE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. 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, 20 minutes after vaccination, the patient experienced possible stroke. As per reporter, "after having my first vaccine, within 20 minutes I had a complete collapse (they believe it was a possible stroke), and was completely out for over 4 hours, unable to walk or speak." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221159008- Possible Stroke. The event has compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
This spontaneous report as received from a registered nurse refers to a 5 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expiry date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Information has been received from a licensed vocational nurse referring to multiple unspecified patients of unknown age and gender. There was no concomitant medication reported. On unknown dates the patients received doses of improperly stored VARIVAX (Merck) (lot # L001335, expiration date 13-JAN-2016; lot # L021215, expiration date 10-JUN-2017; lot # K005428, expiration date 15-APR-2016) (dosage, strength and route not reported). There was no concomitant medication reported. No adverse effects was reported. This is one of two cases received from the same reporter. Additional information has been requested.
Tightness in chest; Headache; This is a spontaneous case, reported by other non-healthcare professional to Med Communications [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 15-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medications were not provided.  On 30-Sep-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number and expiry date: not reported] for prevention of seasonal influenza.  On the same day, after vaccination, the patient experienced tightness in chest and headache. No further details were provided.  At the time of initial reporting, the outcome of the events was not reported.  This case was assessed as non-serious.   The reporter did not provide the causality assessment.  This case is linked to cases: 201905875, 201905876 and 201905878 (same reporter).  Company comment: The patient experienced chest discomfort and headache after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced chest discomfort and headache after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
This spontaneous report as received from an employee referred to her daughter who was a 3 years old female patient with no Pertinent Medical History and no Drug Reactions/Allergies. The patient was subcutaneously vaccinated with 0.5 ml VARIVAX (merck) (lot# unspecified) in September 2010. There was no concomitant medications. On 05-JAN-2013 the patient experienced had a few breakthrough chicken pox. She experienced a fever up to 103.8 which resolved by Monday (07-JAN-2013). She had three spots on her neck, one on her back and belly and one on her right calf. She wasn't getting any new spots. She was recovering and acting normal. She was not seen by her physician. Patient did not seek medical attention. No lab Diagnostics Studies Performed. Ibuprofen was given as treatment for the event. The outcome of a few breakthrough chicken pox was reported as recovering/resolving. The relatedness for a few breakthrough chicken pox was unknown for VARIVAX (Merck). Additional information is not expected.
admitted to hospital last Friday for aFib with a resting HR of 200.; Caller describes this as a "measley chicken pox"; Caller describes this as a "measley chicken pox"; he developed a "really weird rash" on his left upper arm, left side of stomach/chest, and inner left thigh; Caller states he has COPD; I'm quite alarmed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer, Caller received two Covid vaccines administered in his left arm.), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant), outcome "unknown", described as "admitted to hospital last Friday for aFib with a resting HR of 200."; MEASLES (medically significant), VARICELLA (non-serious), outcome "unknown" and all described as "Caller describes this as a "measley chicken pox""; RASH (non-serious), outcome "unknown", described as "he developed a "really weird rash" on his left upper arm, left side of stomach/chest, and inner left thigh"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "Caller states he has COPD"; NERVOUSNESS (non-serious), outcome "unknown", described as "I'm quite alarmed". The patient underwent the following laboratory tests and procedures: Heart rate: resting HR of 200, notes: He has COPD, was admitted to hospital last Friday for aFib with a resting HR of 200. Therapeutic measures were taken as a result of atrial fibrillation, rash, chronic obstructive pulmonary disease.  Clinical information: The 63-year old male seeking information regarding possible side effects of Covid vaccine. Caller received two Covid vaccines administered in his left arm 6 months ago, maybe a month or maybe two months between them, has not received booster. Caller does not have vaccine card or dates of vaccines available. Caller states that six months after second dose, he developed a "really weird rash" on his left upper arm, left side of stomach/chest, and inner left thigh. Caller describes this as a "measley chicken pox rash". Caller states he has COPD, was admitted to hospital last Friday for aFib with a resting HR of 200. He was prescribed medication for this as well as clotrimazole cream for the rash. Caller states the clotrimazole cream has not made any difference in the rash. Caller states he was really scared and concerned", "he was quite alarmed", "he don't wanna die", "there always has to be a casualty". Caller states he has seen images on the internet that look like his rash, stating it is only on the left side of his body.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed fever, headache, neck pain and myalgias several hours after vaccination. Then presented to our hospital 3 days after vaccination with chest pain. ECG concerning for STEMI and patient had cardiac catheterization which showed normal coronaries. Cardiac MRI suggestive of myocarditis.
I had a flu shot (FLUAD 65+ QUAD PF 2022-23) along with the Moderna booster.  The following morning, I experienced chills, headache, muscle/joint pain, and extreme tiredness.  There was no nausea.  I had a low grade fever (99.3) and treated with Advil.  Today, I am feeling much better.
Pt recvd vax & devel sore tongue-feels like it is raw; pt states sore tongue is subsiding now;
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Severe, Systemic: Hypotension-Severe, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: PT REPORTING SHE CANNOT MOVE HER LEG/WALK ALONG WITH ALL ABOVE SYMPTOMS, SHE REPORTED FALLING DOWN AND WAS BROUGHT TO ER. ACCORDING TO PT, ER MD TOLD HER THAT HER SYMPTOMS COULD BE DUE TO COVID VACCINE
First 72 hours after injection - all muscles and joints aching and burning sensation, no fever. 2 inch diameter redness, golf ball sized swelling under the redness. After 3 days, marble-sized hard lump formed in arm at injection site.  Lump persists after 1 week.
After a few months out from receiving  my Dose 3 Pfizer, 11/05//2021 I was diagnosed with COVID positive on COVID positive 01/04/2022 . I was feeling unwell from 01/03/2022 -01/07/2022 head ache, fever, sore eyes, and fatigue.  I went to urgent care who provided testing and diagnosis.  I was advised that it was okay to take the over the counter medication that I had on hand at home.  I feel that I have fully recovered from this issue.
Dizziness started 5 days after getting the vaccine and I'm still experiencing it. A week after getting the vaccine: Skin rash on neck, arms, chest, belly and back. Almost three weeks after the vaccine I still have some arm rash.
Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredness   Treatment, sumatriptan for headaches, Advil for aches , pain and fever.  I was in bed for 2 1/2 days because I felt so sick and was very tired  Most of my symptoms were better after 3 days but the headaches and tiredness are still bothering me today 3/18/21.
After third booster experienced the following:  1. Swelling in left armpit noticed approx 2 days after booster - resolved in 5-7 days 2. Tinnitus and diminished hearing noticed 12 days after booster - diagnosed with asymmetrical sensorineural hearing loss (H90.3) and sudden-onset sensorineural hearing loss (HH91.20) - lost approx 30-40% hearing in left ear - treated with MethylPREDISolone 4mg dose pack starting 3 days after symptom onset + steroid injection in left ear 5 days after symptom onset; symptoms have not yet resolved; another steriod injection may be given in left ear on Dec 1, if needed
leukemia cancer; This case was reported by a consumer via interactive digital media and described the occurrence of leukemia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice). Concurrent medical conditions included pain (had awful extreme pain and still had pain on and off).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced leukemia (serious criteria GSK medically significant). On an unknown date, the outcome of the leukemia was unknown.   It was unknown if the reporter considered the leukemia to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient could not get the shot and had the shingles twice, 1st time was not to bad and 2nd time was awful extremely pain and still had pain on and off. The patient had Shingles shot long time ago since then diagnosed with leukemia. The cancer physician would not let the patient had the shot. The patient was hoping, he/she did not get the shingles 3rd time. The follow up would not be possible as no contact details were available.
Red hot swollen spot on left arm at injection site. Slightly itchy and hard to the touch
Complained of swollen lymph nodes on R side of neck, stiff neck and soreness under R armpit.
Positive for COVID/ before her second booster dose; Positive for COVID/ before her second booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 83 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Allergies to Penicillin" (unspecified if ongoing). Concomitant medications (all started years before) included: OLMESARTAN; BYSTOLIC; ZOCOR; CETIRIZINE taken for hypersensitivity; FLUTICASONE nasal; IPRATROPIUM BROMIDE nasal; OMEPRAZOLE; LORAZEPAM; DILTIAZEM. Past drug history included: Clonidine, reaction(s): "Allergies to Clonidine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Dec2021, outcome "recovered" (20Dec2021) and all described as "Positive for COVID/ before her second booster dose". The event "positive for covid/ before her second booster dose" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Dec2021) Positive; (20Dec2021) Negative; Weight: (unspecified date) 115-117 lbs. Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included an antibiotic.  Clinical course: The patient had 4 doses of Pfizer BioNTech Covid-19 Vaccine including 2 standard doses and 2 booster doses. She has had COVID twice since getting Pfizer COVID-19 Vaccine; the first was before her second booster dose. Since the first series of the vaccine she has had itchy rash all over her legs, arms and body that's like getting hives. Her doctor gave her antibiotic but it wouldn't go away. Doctor gave her the antibiotic in Dec2021 when she had COVID thinking it was hives and it didn't work. She does not know the name of the antibiotic, she only had it for a week or so in Dec2021. Patient stated, "The itchy rash gets worse when you get COVID."
Localized red swelling, soreness, warmth and bruise on left shoulder at injection site. Left eye developed conjunctivitis.
On day 8 following vaccination, developed welt-like area at and below vaccination site;  it itched, slight soreness, pink in color.  Only lasted overnight.  No raised area seen on following morning, but area was still a little pink.  Gone by 2nd morning.
Information has been received from a woman in a physician's office concerning a 5 year old male who on 30-OCT-2000 was vaccinated SC with a first dose of Varivax (lot # 634514/0539K). On 10-SEP-2006, the patient developed chickenpox. The patient recovered from chickenpox on an unspecified date. Additional information is not expected.
Breakthrough case admission after two vaccines Pfizer 3/30/21 Lot# ER8734;  Pfizer 4/20/21 Lot# Ew0161
Localized pain, swelling at injection site.  Low grade 99.8 degree fever.  Malaise.  Pain with movement of shoulder.
This is a spontaneous report from a Contactable Pharmacist, called by a daughter on behalf of her mother. A 93-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and medications were not reported. Her mother thought she may had received Prevnar 13 previously but she was uncertain about this. The patient experienced pneumonia on an unspecified date and was in the hospital at the time of reporting. The outcome of the event was unknown.
PAIN IN ARM AT INJECTION SITE, TIREDNESS,(WENT AWAY) SWELLING AT INJECTION SITE, HARDNESS AT INJECTION SITE,  ITCHING AT THE SITE
Pt recvd DTP/OPV/MMR on 31MAR92 & refused to move arm p/vax; Wed AM awoke crying c/o pain & can't move; mom noted redness & mild swelling1APR92 awoke from nap w/fever & edema extending to & including elbow; c/o malaise;
Information has been received from a 36 year old female medical technologist with no past medical history who on 04/30/04 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Advair. Subsequently, "over the week" the pt developed fever, chills, injection site erythema (6x6 inch in size) and continuous hot flashes with body aches and headaches. The pt contacted her allergist who recommended Motrin and ice. The pt did not believe that she ever had pneumococcal 23v polysaccharide vaccine before. It was reported that as of 0/06/04 the pt was doing "slightly better". No product quality complaint involved. Additional information has been requested.