chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative.  My wife caught Covid from me so I did have ongoing exposure.  Relapse or reinfection? I am a reti; Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative. My wife caught Covid from me so I did have ongoing exposure. Relapse or reinfection?; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 at 13:00 as dose number unknown, single (Lot number: 301358A) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22May2022, outcome "not recovered", described as "Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative.  My wife caught Covid from me so I did have ongoing exposure.  Relapse or reinfection? I am a reti"; COVID-19 (medically significant) with onset 22May2022, outcome "not recovered", described as "Recurrent Covid symptoms and test one week after stopping Paxlovid and 3 days after testing negative. My wife caught Covid from me so I did have ongoing exposure. Relapse or reinfection?". Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.The case will be reevaluated should additional information become available.
Information has been received from a Doctor of Pharmacy concerning a patient with no medical history or drug reactions/allergies, who on 28-APR-2010 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (lot # not available). There was no concomitant medication. On 28-APR-2010, the patient experienced pain at the injection site after vaccine administration. The pharmacist added that the PNEUMOVAX 23 administered had expired on 18-APR-2010. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. No further information is available.
Upper shoulder discomfort, swelling, and pain pt used Ibuprofen and ice the next day to help with pain. Pt believes the discomfort was due to improper placement of the injection too high on the deltoid muscle possibly hitting the bursa in the shoulder.
patient received an expired dose of QUADRACEL with no adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received an expired dose of Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine live (enders-edmonston), mumps vaccine live (Jeryl lynn), rubella vaccine live (Wistar ra 27/3), varicella zoster vaccine live (Mka/merck) (Proquad) for Immunisation.  On 08-Sep-2022, the patient received first dose, 0.5 ml once of Diphtheria-15/tetanus/5 hybrid AC pertussis/IPV(MRC5) vaccine (lot C5763AA, exp date: 26-ug-2022) via intramuscular route in the right thigh for Immunization.  On 08-Sep-2022, (latency: same day) the patient received an expired dose of quadracel with no adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.    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 the 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.
Itching skin - rash - hives around neck and on stomach, hips, lower back. Occurred about 4 hours after receiving vaccine.  Hives continued to occur for almost 2 1/2 wks.   Used oral benadryl, cortison cream and cold packs.  Cool showers as warmth caused the hives to flare.  Loose clothing as pressure caused hives to occur.
Note this is in reference to initial report filed 03/31/2021  -  Received Janssen vaccine for COVI-19 in mid-March 2021. Over the next couple of days, became very ill, spent five days experiencing severe headache, disorientation, confusion, neck, shoulder, and back pain together with generalized arthralgias and myalgias. Around the 2nd week post-vaccination began to experience ?numbness and tingling? initially, affecting all fingers and toes; symptoms gradually evolved into ascending paresthesia affecting the upper and lower extremities. (worse in the upper extremities). Neurological symptoms are accompanied by painful electrical-like impulses running along my spine and elicited by flexing my neck (Lhermitte neurological phenomenon). Neurological signs and symptoms prompted me to go to the emergency room. Currently, I am under the care of a neurologist and undergoing extensive diagnostic workup.  Present treatment: Glucocorticoids (tapering) and Gabapentin. Among the initial rule out diagnosis, were transverse myelitis, and Guillain Barre. Present preliminary r/o diagnosis: Post-vaccine immune reaction ? No definitive diagnosis yet.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sulfa-based medications allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lortab [loratadine], reaction(s): "Allergy"; Morphine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received treatment with Paxlovid from 15Sep2023 to 20Sep2023 for COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt developed induration, erythema, >5inches extending from deltoid to below the elbow with tingling in his fingers. Pt treated with a Prednisone course taper and recovered fully.
RN administered Pentacel (Dtap/IPV component) in addition to fully reconstituted Pentacel (Dtap-IPV-HIB) vaccine. Provider and family were informed, no treatment indicated. Family reported low grade temp within 24 hours, no additional symptoms.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 13-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion with 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49.1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
J&J given at 17 years of age.  No adverse reactions noted at time of reporting.
This spontaneous report was received from a registered nurse and refers to multiple refers of unspecified age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was reported. On an unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # K026242, expiration date: 28-JAN-2017; dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Got COVID; Got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EN6207) and on 14Apr2021 as dose 2, single (Lot number: ER8733) at the age of 58 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Chronic Kidney Disease Stage 2 mild" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "gastric issues" (unspecified if ongoing); "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 30May2022, outcome "recovering" and all described as "Got COVID". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High; Blood pressure measurement: High; Computerised tomogram: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical course: She states her Covid-19 Vaccinations were Pfizer. She was fine after her first dose of the Covid-19 Vaccine but she had a reaction after her 2nd dose. She was out of commission for 10 days with an inner ear infection in both ears. Her rheumatologist said given her reaction and being a lupus player and trying the Benlysta Infusion, she should not receive any boosters for the Covid-19 Vaccine. The Benlysta Infusion was done at a center and she had her last one in March because the infusion was not working. Caller got Covid on Monday, 30May2022. She has today and tomorrow left to take Paxlovid that was prescribed.  No follow-up attempts are possible. No further information is expected.
DILUTED VARICELLA WITH BOOSTRIX - ADMINISTERED TO PATIENT SUBCUTANEOUSLY; NO REACTION OR ADVERSE EVENT NOTED; PARENT INFORMED OF ERROR. REVIEWED POSSIBLE REACTIONS TO IMMUNES AGAIN.
Patient received vaccine 31 days after refrigerated.; No adverse event; 4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (first dose ,Lot AS1414B) on 27-Jun-2022, Moderna COVID-19 vaccine (second dose and Lot AS1412B) on 02-Aug-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 31-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4-year-old patient received an expired 3rd dose Moderna Bivalent Pink Cap COVID-19 vaccine on 31AUG2023, beyond 30 days use by date.) and PRODUCT STORAGE ERROR (Patient received vaccine 31 days after refrigerated.).    No concomitant medication was reported. t was reported that looked up date was 22-Nov-2023. No treatment medication was reported.
On 3/7/01, phone contact from caregiver; she reports child has a local reaction to the vaccine in left arm. Has an area of redness and induration somewhat larger than a quarter, child complaining of soreness, there is no fever. Reports active movement of arm but is fussy if the arm is touched. No loss of appetite. Told to use Tylenol every 4 hours and apply cold pack to site. Family to return to clinic on 3/8/01 for PPD reading. On 3/8/01, arm was checked and left deltoid still swollen and red. Redness extends about midway of the arm but not swollen down the arm. Area is still sore. On 3/9/01, called and spoke to grandmother who is his caretaker during the day. She reports that he is much better today. Arm is not sore and the redness is going away. Activities are normal.
Swelling of arm extending into shoulder and below elbow. Tingling of hand, sore shoulder & elbow. Hurt ot move arm. Hand cold. Treated with ibuprofen, rest, cold compresses.
Started with break out on scalp, Then lymph Nodes swollen in neck area.  then turned into hives break out over entire body.
Patient reports shoulder or elbow joint pain and immobilization after each Anthrax injection which would last anywhere from 2-3 weeks, with each injection on the following days 7 Nov 98, 20 Nov 98, 6 Dec 98, 15 May 99 12 NOV 99, and 11 May 2000.  Subsquently, has developed lower back pain, neck pain and generalized body arthralgias with exercise and with activities of daily living.  Pain has waxed and waned over time, somewhat relieved with NSAIDS (Vioxx).  Patient currently being followed by a Rheumatologist.
Patient received her Shingrix vaccination and then the next morning she had a rash starting on the right side of her face. She experience itching, and burning. Today (01/30/2021), she called our pharmacy to let us know that the redness and rash are now spreading to the left eye. I referred her to urgent care, and informed the on call provider to make a note in patient's chart in her PCP's office.
Myopericarditis, chest pain. Started roughly 9/15/2021. Vaccine received on 9/13/2021. Admitted to the hospital.
Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 03BA21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Adhesive tape allergy (Adhesive allergy, allergic to tape.), Seasonal allergy (Seasonal environmental allergies), Drug allergy (Allergies to medicines for osteopenia) and Drug allergy (Allergies to medicines for osteoporosis). Concomitant products included CALCIUM and PREDNISONE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose) outcome was unknown.            The patient was receiving immune drugs for cancer when she received the first and second doses of the vaccine. The patient never had positive COVID-19 test or diagnosis. The patient received  seasonal allergy shot last fall and believes it was on Sep 2021. No treatment information was provided.   This case was linked to MOD-2022-527617 (Patient Link).
Child received orange (5-11yrs) COVID bivalent vaccine as dose 1. no reaction to vaccine, child tolerated vaccine.
Pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event; Initial information received on 14-Nov-2022 regarding an unsolicited valid non-serious case received from the patient's parent.  This case involves child of unknown gender patient whose parent reported that pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event, after receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], meningococcal vaccine A/C/Y/W conj (Tet Tox) [Menquadfi], influenza quadrival A-B multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection (strength, dose, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for immunisation.  On an unknown date, the patient received a dose of suspect, meningococcal vaccine A/C/Y/W conj (Tet Tox) (strength, formulation, dose, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect influenza quadrival A-B multidose vaccine preserved suspension for injection (strength, dose, frequency, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient's parent reported non-serious event of, pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event (product dose omission issue) (latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine, meningococcal vaccine A/C/Y/W conj (Tet Tox), influenza quadrival A-B multidose vaccine preserved.  It was reported that, "Pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused. She asked how long these vaccines will be good for. Vaccines involved are; Menquadfi, Adacel and Fluzone QUADRIVELENT. MIS discussed and emailed stability SRD".  Action taken: Not applicable.  Outcome: Unknown.  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 the 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.
I got shingles approximately two weeks after the vaccination date. The doctor didn't think it was related to the vaccine, but I wanted to report it since it is rare in people under 50.
swollen lymph nodes/inflammation of lymph nodes; now she has pain in the area where they were taken out and then she had swollen lymph nodes another place; inflammation is on the left arm; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 16Jun2021 as dose 1, single for COVID-19 immunization. Medical history included I had cancer 4 years ago, she had lymph nodes taken (removed from radiation), glucose issue and she was allergic to flu vaccine. Concomitant medications included anastrozole (Estrogen blocker). She did not take any vaccines within 4 weeks prior COVID vaccination. The patient previously took flu vaccine VII (Batch/Lot number and Expiry date: Unknown) for immunisation and experienced allergic to flu vaccine. On an unspecified date in 2021, the patient experienced with swollen lymph nodes/inflammation of lymph nodes, now she has pain in the area where they were taken out and then she had swollen lymph nodes another place and inflammation is on the left arm. On an unspecified date patient stated that there was a diet sugar in the COVID vaccine. She got the COVID vaccine already. She clarified if she had a glucose issue and just wanted to know what type of sugar was in the vaccine. After the first dose of the Pfizer COVID vaccine she had inflammation of lymph nodes. she was allergic to flu vaccine (got bronchitis and cough for 3 months). Patient did not receive any treatment for the events. The outcome of the events was unknown.   Information on Lot/Batch information has been requested.