chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose Number:1, Date of start of drug: 23FEB2021/ Dose Number:2, Date of start of drug: 2MAR2021; Dose Number:1, Date of start of drug: 23FEB2021/ Dose Number:2, Date of start of drug: 2MAR2021; Headache; Lethargy; Injection site pain; This is a spontaneous report received from a contactable other hcp. A 41-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 02Mar2021 08:30 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient had not covid prior vaccination. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Patient received first dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration in Arm right on 23Feb2021 08:30 as single dose for covid-19 immunization. The patient experienced headache, lethargy, injection site pain on 02Mar2021 11:00. Patient received inappropriate schedule of vaccine on 02Mar2021, which is off label use. No treatment was received for the events. The outcome of the events headache, lethargy, injection site pain recovered, and the other event was unknown.  No follow-up attempts are Possible. Information about lot/batch number can-not be obtained. No further information is expected.
Vesicular rash on patient: It is mainly on his back spreading to his left and right axilla and  Upper and lower extremities.  It looks like chickenpox.  He is not complaining about itch or pain.  We did not give him anything for it since he did not complain.  The staff noticed when they were bathing him and felt the bumps on his back. It was hard to see initially bc of his skin color, so it was noticed 9/9/19 during his shower. It could have been there this past weekend, but possibly not noticeable yet.
It's been six months since my shots, suddenly I'm getting soreness in my arm muscles and joints.  Nothing has changed in my daily routines. so this constant soreness and pains seem totally not normal.  I'm just curious is others are experiencing delayed reactions also?
loose joint; joint pain; This spontaneous report has been received from an unspecified reporter from healthcare office reported to her daughter of unknown age (reported as in college now). The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On an unknown date in 2017 (reported as possibly 4 years ago, when the patient was in high school), the patient was vaccinated Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiration date not provided) for prophylaxis. On an unknown date in 2017, around the same time, the patient was diagnosed with loose joint, joint pain. The patient had done every kind of therapy for years. The outcome for the events was unknown.  The causality between the events and the suspect vaccine was not provided.
Moderna COVID-19 Vaccine EUA. Tingling in the right arm. Also sore ness on the right shoulder. Itchy ness in the throat and miner headaches.
Patient developed general joint pain after first dose of LYMErix. On 3/8/00, the patient received her second dose of LYMErix. As of 6/20/01, the patient continued to have general joint pain. Additional information has been requested. The follow-up states that the vaccinee had gastroesophageal reflux disease and hypertension. On 02/04/2000, the vaccinee received her first dose of LYMErix. That day after the vaccine had been administered, she began to experinece eneral joint pain. The reporter stated that the adverse event was of moderate intensity. she was treated with ibuprofen. Follow up states that she had no history of gout, psoriasis, Crohn's disease, or Lyme disease. She had no family history of rheumatoid arthritis or lupus. The joint pain persisted. The vaccinee's joint complaints have not been evaluated by a physician. No swollen or warm joints have been noted on physican examination. No joint fluid was obtained. Erythrocyte sedimentation rate, measured on an unspecified date was within normal limits. Antinuclear antibody titer, measured on an unspecified date was negative. The reporter stated that the LYMErix immunization series was to be completed on the recomendation of the centers for disease control and prevention. The vaccinee was to receive her third injection of LYMErix on her next visit. Outcome of the joint pain was not provided. The follow-up states allerigies and concomitant medications were not specified. The vaccinee had gastroesophageal reflux disease and hypertension. On 02/04/2000, the vaccinee received her first dose of LYMErix. That day, after the vaccine had been administered, she began to experience "general joint pain." The reporter stated that the adverse event was of moderate intensity. She was treated with ibuprofen. 07/26/2001, the vaccinee continued to have "general joint pain." Additional info has been requested.
pt recvd flu & pneumovax 2PM 10NOV by 11NOV t101, ached all over, lt arm painful, difficult to move, erythema shoulder to elbow; stayed home in bed; 12NOV very tired, temp up to 101 by evening, diaphoretic; by noon tired, h/a in bed for 24;
A vial of a previously diluted and mostly empty vaccine was diluted with saline (instead of a new vial). Accidentally assumed to be the correctly concentrated vaccine. Thus, patient was given an extremely diluted vaccine that was mostly saline instead of the correct concentration of the vaccine. The error was discovered approximately one hour after vaccination. Offered to revaccinate with the booster dose 3.
adult was administered pediatric dose; adult was administered pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 31-year-old patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 3rd March 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK Receipt Date: 05-APR-2022 Reporter's Comments: The patient received Engerix B in left deltoid. The reporter did not consent to follow-up via email or postal. Other supportive information: An adult patient was administered a pediatric dose of Engerix-B inadvertently, which led to accidental underdose and adult use of a child product.
pt recvd vax 24SEP95 runny nose, cough 1 wk later, 3 days later fever; rash 6OCT95 hop 5-6;h/a 9photosensitive)
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number L040181, with an expiration date of 18-AUG-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 vaccine had a temperature excursion. The highest temperature excursion was of 47 Fahrenheit (F), (8.333333333 Celsius degrees) for a total of 24 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter.
pain in thigh bones; pain in my left hip; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in thiGH bones) and ARTHRALGIA (pain in my left hip) 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 PAIN IN EXTREMITY (pain in thiGH bones) and ARTHRALGIA (pain in my left hip). At the time of the report, PAIN IN EXTREMITY (pain in thiGH bones) and ARTHRALGIA (pain in my left hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
UTI; tested positive for covid; This is a spontaneous report from a contactable consumer. This consumer (granddaughter) reported for a female patient (grandmother) that a 92-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine), via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: unspecified) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was taken to emergency room yesterday. She was acting funny because she had urinary tract infection (UTI) on an unspecified date.  She had no symptoms but tested positive for COVID while in emergency room on 07Feb2021. The caller was asking if grandmother should be tested again for covid. The patient underwent lab test which included covid test (Sars cov-2 test) and the results were positive on 07Feb2021. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (sick the next day after booster 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. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick the next day after booster dose). At the time of the report, ILLNESS (sick the next day after booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant were reported. No treatment were reported.
Pt recv vax on 10/9/98; on 10/11/98 pt exp nausea & vomiting
In October 2000, the patient began experiencing chicken pox. Many lesions are noted, over 50, "peppered with lesions". The patient's sister had a similar experience following exposure to varicella virus vaccine live. Follow up information from the NP indicated that the patient developed varicella greater than 100 lesions, "peppered" in October 2000. The patient subsequently recovered in November 2000. No further information is available.
Had Anthrax rt arm-booster with ensuing area of erythema, (+) pain with any movement of tricpet muscle. No drainage noted #7 annual booster
Patient received the vaccine on 12/23.  Patient reports fever and fatigue from 12/24 ? 12/27 and developed hives on 12/26 and a diffuse red rash on 12/28.  Patient was treated in the ED 12/28. On 12/28/20 patient was diagnosed with Diverticulitis, Allergic Reaction. Patient discharged with antibiotics and corticosteroid.
pt recv vax 3DEC96 & was exposed to varicella on 6DEC96 & 12DEC96 pt exp t102, devel a gen rash;16DEC96 pt had greater than 50 lesions on body & an additional 35 lesions on face;pt was hosp;
Approximately 1 hour after the injection I experienced numbness on the right side of my face and and nose.  I also experinced throat constriction.  I self administered 25mg liquid diphenhydramine 10 minutes after the reaction started.  Symptoms lessened within 30 minutes and had resolved within 2 hours
Developed wheezing after receiving the doses of Vaxelis; This serious case was retrieved by partner on 19-APR-2023 with reference number: 02373539 and (Interaction # 02373518). The original narrative from the sender is confidential. It refers to a patient of unknown age who was treated with Vaxelis and experienced Wheezing.  Company Comment Wheezing was assessed as serious due to prolonged hospitalization.  Wheezing is unlisted for Vaxelis as per the Reference Safety Information (CCDS).  Considering the current knowledge on Vaxelis (wheezing unlisted), and that the events occurred after receiving the doses of Vaxelis on an unknown date, and lack of information in this case (medical history) and in absence of confounding factors (co-suspect vaccine) reported, and that the hospital doctor did not think that these symptoms were related to Vaxelis, the causal relationship between Vaxelis and the event Wheezing is assessed as not related.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Wheezing was assessed as serious due to prolonged hospitalization.  Wheezing is unlisted for Vaxelis as per the Reference Safety Information (CCDS).  Considering the current knowledge on Vaxelis (wheezing unlisted), and that the events occurred after receiving the doses of Vaxelis on an unknown date, and lack of information in this case (medical history) and in absence of confounding factors (co-suspect vaccine) reported, and that the hospital doctor did not think that these symptoms were related to Vaxelis, the causal relationship between Vaxelis and the event Wheezing is assessed as not related.  This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
severe fatigue, dizzy, palpitations, breathing issues Holistic treatment -stem cell supplements Cellorane #3 27 days
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS THE INITIAL DOSE (APPROXIMATELY AROUND 0.3ML); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose (approximately around 0.3ml). On 01-DEC-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the individual received less than 0.5ml of the janssen covid-19 vaccine as the initial dose (approximately around 0.3ml) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211210067, 20211209551, 20211210058 and 20211210160.
Dose #1 Hep B vaccine given. After approx 1 minute recipient complained of metallic taste in mouth. Within 5 minutes he c/o feeling dizzy. Unsteady on feet; face flushed. Small amt vomiting. C/O numbness at back of throat. VS 142/90, P 72 T 98.5 o2 sat 99. Taken to ER/ambulance.
Mother reports post vaccine that evening pt developed hives on her legs, the hives spread over her entire body. She was treated with acetaminophen. She recovered.
I got the second shot on 6/7/2021 around 9:00am. The Nurse provided me with Ibuprofen. I had some fatigue making it difficult to drive and work without fighting the urge to doze off.  Around 9am on 6/7/21 I started to experience body aches, fever, and headache. I took Tylenol and went to bed. Around 1:00 am on 6/8/2021 I started to have uncontrollable spasm and shaking.  Around 2:00 am went to see my PCP. He suggested that I take a rotation of Tylenol and Midol. on 5/11/21 I went to the emergency room for the bad muscle spasms and jerking
I was ''chilling'' like my body.; I was having fever; feeling like cold; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) as dose 3 (booster) , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization; Bnt162b2 (DOSE:2), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "I was ''chilling'' like my body."; PYREXIA (non-serious), outcome "unknown", described as "I was having fever"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "feeling like cold"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: It was reported that the patient enquired about administering Tylenol for headache after receiving booster dose. Have headache so, taking Tylenol but some people say, cannot take Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site of vaccine red, hot and patient desribed sore throat/ throat tightness 24 hrs after shot administration.
pt recv vax 10JUL96 & 11JUL96 pt exp local induration on arms from shoulder to elbow, & large, painful erythema;pt was afeb;
Menquadfi reached a low temperature of 32.9F with no reported adverse event; vaccine was administered to 8 people after the excursion. She says that the excursion was caused by additional gel packs being placed in the refrigerator with no reported adverse event; Initial information received on 18-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA157696(CLUSTER) and 2023SA157204(CLUSTER).  This case involves a 18 years old and unknown gender patient who was administered meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] after the excursion that reached a low temperature of 32.9f with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (YEAST) (Gardasil) and meningococcal vaccine B (Meningococcal Vaccine B) for Prophylactic vaccination (immunization).  On 10-May-2023, the patient received 0.5 mL dose 2 of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (lot: U7576AB; expiry date: 28-Feb-2025) via intramuscular route in the left arm for immunization with no reported adverse event (poor quality product administered) (same day latency) and on an unknown date underwent excursion, reached a low temperature of 32.9f with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805427 was crossed linked to original case 201804863 due to same reporter.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022 at 5:56 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 5:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (The Moderna monovalent and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).
Covid vaccine: left arm injection site is sore and red-looks like a rash. It is warm and arm is sore.
A catch-up immunization scheduled was used for immunization series. 1st doses were 1-25-07. No adverse event noted.
Pt reports being sick x 4 days after receiving vaccine then went into lupus flare Narrative:
pt recv vax 5SEP96 & exp nausea, lethargy & feeling lousy;
Meningococcal was mistakenly administered instead of Pneumococcal conjugate.
Presented with diverticulitis with perforation also positive for covid asymptomatic. once stable pt discharged home to follow up with GI.