chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 single dose injection for the prevention of pneumococcal disease. No concomitant medications were reported. On an unknown date the patient experienced swelling under the arms after administration of PNEUMOVAX23. The outcome of swelling under the arms was reported as recovering/resolving. Additional information has been requested.
o Parent/Guardian attested and submitted 2 separate forms confirming that patient date of birth is October 16th 2016 o I tried to correct DOB but the system wouldn?t allow it. Guardian did not want to provide birth certificate to submit to the agency for change o Patient received the Pfizer 5-11
Left arm pain and swelling  started approximately 12 hours after receiving vaccine, patient was seen in the ER and dx with Acute Deep Venous Thromboembolism, patient started on Eliquis
Shortly after injected patients color pale, pupils dilated and skin clammy to touch. Mom shared patient history of passing out with injections. Patients seat reclined and ice pack applied to head and nape of neck. BP 102/50 ,pulse 60 BPM and SPO2 93%. Patient pupils back to normal after a few minutes. Given apple juice.  After 15 minutes, seat elevated and vitals were BP 110/88, pulse 67,and SPO2 100%. Observed for additional 15 minutes, patient had returned to baseline and was released with mom.
ITCHING, SEVERE PAIN, RASH, BODY ACHES, SLEEPLESSNESS, WEAK
full series of standard vaccine with Pfizer and Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspect possible psoriatic arthritis (mild)" (unspecified if ongoing), notes: not currently diagnosed or undergoing treatment.; "known allergies: certain metals and dyes" (unspecified if ongoing); "known allergies: certain metals and dyes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Rabies vaccine (known allergies: Rabies vaccine), for Immunization, reaction(s): "known allergies: Rabies vaccine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "full series of standard vaccine with Pfizer and Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Test was never negative, but had faded to faint positive; Positive, notes: now much darker than initial positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: This report was about covid treatment. Patient received covid vaccine Moderna Bivalent (rec'd full series of standard vaccine with Pfizer and Moderna). Vaccine lot unknown reason stated as not available/provided to reporter at the time of report completion. Patient received anti-viral product Paxlovid for COVID 19 Treatment from 25Jan2023 till 29Jan2023. Experienced rebound COVID symptoms approx. 4 days after finishing Paxlovid course.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events drug ineffective, COVID-19 and Interchange of vaccine products cannot be ruled out.
Inflammation on left side of face, left arm tingling plus numbness. She went into emergency room the next day after the shot and was put on steroid.
when getting dressed, same night of vax, started getting the chills. Woke up at 6 am, everything on left side of body was painful, aching, stayed that way the entire weekend. Has pinched nerve on right side, but reaction came from vaccine on left side. Very painful. This is first dose. Still has pain in area where muscles.
Approximately 24 hours after injection (05/16/21), lymph nodes became sore and painful under right arm.  Within 48 hours lymph nodes under left arm, right arm and breasts became very painful and felt swollen and remained like that for 5 days (through 5/21/21) when side effects began to diminish. In addition, 48 hours after injection, shingles appeared on right back, shoulder and chest. Still dealing with the shingles to date (5/30/21). Have a DR. appointment on 6/1/21.
two patients (twins) were administered expired doses of ACTHIB.; Initial information regarding an unsolicited valid non-serious case received from  via other health care professional on 02-Nov-2020.  This case involves a 01 year old patient who received administered expired doses of HAEMOPHILUS TYPE B (HIB) VACCINE (ACTHIB) (lot: UJ112AAB, expiry date: 21-Jun-2020), via unknown route, on an unknown date (PT Expired product administered)  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Expired vaccine used (LLT). It was reported that the vaccine was two patients (twins) were administered expired doses of ACTHIB.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.
It's warm and red; Not majorly sore but I'm starting to feel something again that I haven't felt; Feeling itchy in that spot (at injection site); After scratching, area is red and it's been getting bigger; Arm got a little sore and sensitive to touch; Arm got a little sore and sensitive to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch), SENSITIVE SKIN (Arm got a little sore and sensitive to touch), VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt) and VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch) and SENSITIVE SKIN (Arm got a little sore and sensitive to touch). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt), VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) and VACCINATION SITE ERYTHEMA (After scratching, area is red and it's been getting bigger). On 10-Mar-2021, PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch) and SENSITIVE SKIN (Arm got a little sore and sensitive to touch) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt), VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) and VACCINATION SITE ERYTHEMA (After scratching, area is red and it's been getting bigger) outcome was unknown.        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 relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a health professional concerning her 14 yr old son who at the age of 12 on 13Nov00 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. Two years later, on 28Mar02, the pt experienced a full blown case of chickenpox. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient has red swollen area, size of an egg on the back of the left arm. No fever, no rash. Taking Advil.
Rash developed near injection site approximately 12 days after vaccination. Circular rash was about 3 inches wide, sensitive to touch with very light pain (less than a bruise), but otherwise was not very noticeable. Rash is also slightly warm to the touch. Inside of circle fading faster than outer ring. Currently, rash is fading and a smaller rash appeared above the large circle.
Pfizer COVID vaccine (1st dose) use for COVID-19 under Emergency Use Authorization (EUA): 5 min after receiving vaccine, patient developed severe allergic reaction requiring evaluation in ER (inflammation, rash, and pain)
tested positive for Covid-19 even though fully vaccinated; tested positive for Covid-19 even though fully vaccinated; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 28Jan2021 (Batch/Lot number and expiry was not reported) as single dose, and second dose of BNT162B2 (Solution for injection) via an unspecified route of administration, administered in arm left on 18Feb2021 (Batch/Lot number and expiry was not reported) as single dose, both for covid-19 immunisation at clinic (at the age of 29years and was not pregnant). There was no other vaccine in four weeks and no covid and covid test prior vaccination was done. No Medical history was none and there were no known allergies. The patient's concomitant medications were not reported. On 08Apr2021, the patient tested positive for Covid-19 even though fully vaccinated and Covid-19 was confirmed on 10Apr2021 with lab tests SARS-COV-2 antibody test (via nasal swab with PCR test). The patient went to doctor or other healthcare professional office/clinic and however no therapeutic measures were taken. The outcome of the event tested positive for Covid-19 even though fully vaccinated was recovering. Information on Lot/Batch number has been requested.
8 days after injection,  itchy, swelling, redness then went away. 9 days after, redness returned with pain  at injection site and shoulder joint
4:09 pm c/o a feeling of pins and needles sensation from shoulder to finger tips.  Nail beds pink with quick capillary refill.  Above sensation occurring in left arm and hand.  Instructed to remain in observation an additional 30 min. Agreed. 4:20 pm stated tingling and other sensation of pins and needles subsided somewhat in left arm.  Stated felt well enough to drive home.  Instructed if symptom returned call 911or seek medical advice.
Left hand swelled up; Left arm was a little tender; This spontaneous case was reported by a consumer and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy, Drug allergy (Codeine Allergy), Drug allergy (Sulfa allergy), Iodine allergy and Sun sensitivity (Allergic to sun (causes eczema)).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included Vitamins. Treatment medications were unknown.    This case was linked to MOD-2021-035104 (Patient Link).
questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle). On 23-Jan-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle) had resolved.            No concomitant and treatment medication details was reported. The injection was given in the upper arm instead of the muscle.
I have severe pain in my left arm.  Has lasted 48 hours!  Injection area sensitive.  However, entire shoulder and surrounding area is painful.  Cannot even lift my arm above my waist without sever pain,  Cannot even pick up a cup off coffee/soda.  Feels like a muscle tear in my deltoid muscle area.  Able to bend my arm at the elbow, but that is the extent of my mobility.   No other pain throughout my body.
ARTHRALGIA; THERAPEUTIC RESPONSE DECREASED. Information has been received from a woman in a physician's office concerning an adult female patient with no allergies or medical history who 20 to 30 years ago, in approximately 1983, was vaccine rHBsAg (yeast) (manufacturer unknown). There was no concomitant medication. It was noted that the patient had a positive titer at that time. Subsequently, the patient experienced achy joints and was told that "it was from the live virus in the vaccine." A toter on 13-OCT-2003 was negative. Unspecified medical attention was sought and a prescription drug was not required. A product quality was not involved. Additional information was received from the physician's office which indicated "patient no longer here." No further information is expected.
Patient received both Bexsero and  Trumenba at the same appointment in Error. The error was discovered on 6/1/22. The mother of the patient reported about an hour after receiving the vaccine the patient complained of right arm numbness/tingling and legs feeling numb. Patient also complained of headache and nausea. Patient reported he felt feverish the next day. mom had to pick the patient up from School due to patient feeling ill. Patient reports a constant headache since time of vaccine, has not resolved. Is now also complaining of neck pain, tightness.
Information has been received from a physician concerning a 5 year old patient (gender unknown) who "about 4 years ago" was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In approximately 2003 the patient experienced a mild case of chickenpox. Subsequently, the patient recovered from mild case of chickenpox. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful. This is one of several reports received from the same source. No additional information is expected.
Red papular rash. Employee states it began on 5/14/06. By 05/18/2006 rash was just on chest. Had been taking Benadryl25mg every 4-6 hrs. Had a script for Allegra for another issue from her personal Dr was not taking it. On 05/19/06 Dr advised. Allegra qd and Medrol dose pack.
Severe body chills, shivering from head to toe, couldn?t get hands and feet warm even with multiple layers of clothing. Body aches. Fingers, hands, back, knees, neck, arms, basically everything. Took two Advil. Didn?t help. Chills subsided at some point during the night, but body aches continuing despite taking Meloxacam. Currently 11:30am on January 5th.
Narrative: COVID infection following COVID vaccine series 02/04, Pfizer, dose #1 02/22, Pfizer, dose #2 11/12, Pfizer, dose 3 12/27 COVID swab, result: detected 12/27 pt cc: cough, fatigue myalgias, sore throat, exposure, family
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for himself/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
problems with her legs; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (problems with her legs) in a female patient of an unknown age 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 LIMB DISCOMFORT (problems with her legs). At the time of the report, LIMB DISCOMFORT (problems with her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the friend did not have diabetes. No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-403137 (Patient Link).
last dose of Covid vaccine on 9Jan and then had an antibody test on the 27 and it came back negative; This is a spontaneous report from a contactable pharmacist (patient) via Pfizer-sponsored program. A female patient of an unspecified age received the second single dose of BNT162B2 (PFIZERBIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 09Jan2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first single dose of BNT162B2 (Pfizer BioNTech) on an unspecified date for COVID-19 immunization. The patient received both doses of the Pfizer BioNTech COVID-19 vaccine. The patient's last dose of Covid vaccine was on 09Jan2021 and then had her blood tested on 27Jan2021. She wasn't sure about the type of test that she had but she had mentioned a "polypeptide nucleotide test" and said that she had the standard test for all blood centers. She further stated that her antibody test came back negative. She was wondering if the test should show that she has antibodies. She wanted to know if that was typical. The event was assessed as non-serious.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
LIQUID SEEN DRIPPING OFF THE ARM AFTER ADMINISTRATION OF VACCINE; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced liquid seen dripping off the arm after administration of vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of liquid seen dripping off the arm after administration of vaccine was not reported. This report was non-serious.
17 year old patient got the 1st dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got the 1st dose of the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got the 1st dose of the vaccine). On 03-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got the 1st dose of the vaccine) 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 drugs were reported. No treatment medications were reported.
Patient administered PCV, Hep A, and DTaP on 9/1/09. Within a few hours patient noted to have hive like rash on body. By 9/2/09, rash all over body. Reports same type reaction after 6 mos shots. No treatment other than BENADRYL.