chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6/14 Received 2nd dose of Pfizer vaccine 6/22 Woke up at 8am voilently vomiting - 7 times during the day - last time @9:00 pm 6/23 Realized tongue was lacerated, legs feeling heavy 6/24 Legs feeling extremely heavy - hard to stand up and walk 6/25 Went to Urgent Care - took blood tests - sent home  6/26 8:00 am Received call from Urgent Care - CK levels were extremely high 8:15 Went to Emergency Room, CK levels = 120,000 Admitted to hospital - received IV, CMP blood tests,  6/27:  CK levels reduced to 66,000 6/28:  CK levels reduced to 30,000 6/29:  CK levels reduced to 18,000 6/30:  CK levels reduced to 6,000 - released from hospital 7/7:  Follow-up with primary care physican - CK levels 3,000 7/8:  Follow-up with neurologist (telehealth visit) 7/14:  Follow-up with primary care physican - CK level 300 7/28:  Follow-up with primary care phyiscan - CK level 198 8/1:  2nd seizure at 7:45 am witnessed by parents - called 911 - went to emergency room, released with Levetiracetam 500mg 8/4:  Follow-up with new neurologist - scheduled EEG, brain MRI, stress test, 24 hour monitor  8/10:  3rd seizure at 7:15 am (found on floor) - called 911 - went to emergency room, admitted to hospital for brain MRI 8/11:  Brain MRI normal, released from hospital - cause for seizures unknown - blood work and MRI normal 8/18:  Scheduled for EEG
Injection site red traveled across chest and to left side up face and into hairline. Red areas not raised, no SOB. BENADRYL 25mg P.O. administered 9:03, red areas calmed slightly pt observed for 2 hours reddness and swelling w pain at site remained x3 days.
At the time of injection, after 5 minutes she had muscle pain from what she thought was the vaccine. By noon, she could not move her arm. That did not subside until 4 days later. Day 5 it still hurt but was getting better. She reports she is still not sleeping well at night. She said she can barely put her sports bra on or pull up her pants without it hurting. She did try Motrin, and it helped with the throbbing pain but not with her range of motion. Ice does help a little bit.
Fever, generalized body aches, headache, nausea,diarrhea, malaise.
Systemic: Fainting / Unresponsive-Medium, Additional Details: pt passed out and hit head on glass screen behind chair then woke up in a few minutes completely responsive afterwards.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 26-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008383; 1310USA008385; 1310USA008386; 1310USA008388; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
expired dose of Daptacel was inadvertently administered to a patient, no adverse event; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who was vaccinated with a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5202AA and Exp. Date May-2019) on an unknown date.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was not reported at the time of reporting whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
(Rt) arm pain, growing erythematous patch (rt) arm at varicella injection site. Dx cellulitis. Treated with Clindamycin.
reported feeling itching, abdominal pain, unusual swelling ( inside mouth upper lip and left side of face), swelling of throat, pain on soles of feet and swelling hands on 4/19, she took an antihistamine and symptoms lessened and went away
Completed COVID vaccine series on 02/17/2021; tested positive for COVID 04/21/2021
While at a UVAX event, a client was scheduled to have his second dose of the Pfizer vaccine. While interviewing the client, he reported experiencing a linear rash on the abdominal area and slight difficulty breathing during the first dose of the Pfizer vaccine on 7/16/21. We edited our records, gave the 2nd dose of the vaccine, and monitored the patient for 30 minutes for any anaphylactic reactions. The patient did not report having any allergic signs and symptoms during and after the 30 minute monitor time. The patient mother verbalized understanding instructions.
No additional AE information/ What was the patient's response? Well tolerated; Clinical supervisor calling to inquire about safety of dose of VARIVAX that expired 24MAR2022 that was administered to patient; Indicate at which point in the process the medication error occurred: Preparation for Administration; This spontaneous report was received from a physician and the clinical supervisor referring to a 1-year-old male patient. The patient's pertinent medical history, drug reactions, allergies, and concomitant medications were not reported.   On 28-MAR-2022, a medication error occurred in preparation for administration of varicella virus vaccine live (oka/merck) (VARIVAX) (product preparation error). Therefore, the first 0.5 milliliters (ml) dose (valid lot number T010313, expiration date 24-MAR-2022) was administered subcutaneously (once) for prophylaxis to the patient (expired product administered) by a healthcare professional. The product did not undergo any temperature excursions.   No additional adverse events (AE); the patient well-tolerated varicella virus vaccine live (oka/merck) (VARIVAX).
Significant increase in tinnitus symptoms over the last several months.  I have had to increase the amount of "white noise" (masking) in order to sleep.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:03 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.87 for dose administered on 02-Mar-2021 and 68.95 for dose administered on 30-Mar-2021. No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021. Batch number 014M20A administered on 02-Mar-2021 underwent temperature excursion with temperature range 27 to 36 degrees Fahrenheit from 09:00 Am to 03:00 PM . This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Vaccine was given by a pharmacy. Per mom's history with in 30 hours post vaccine patient began with rash on ankles that moved up body. Initially macular papular . Became more target / (fixed) hive like  over entire body . No rash on face , macular papular on palms,  no rash on soles . No lip/facial  swelling or trouble breathing. Unclear if pruritic- mom said "only at night" .  (I have pictures) . Fully resolved with in 7 days - likely before
Right side parotitis and fever developed 8 days subsequent to vaccine administration.  Required parenteral antibiotic administration and hospitalization.
10 minutes after injection developed bright red hives from chest to thighs, across abdomen and back, inside of arms.
A few hours after receiving the 2nd does of the Pfizer Covid19 vaccine patient started experience chest discomfort which grew increasingly worse over the next few hours. She went to the Emergency Room at the  in , . The provider indicated she had either low-grade pericarditis or early myocarditis related to the Covid vaccine. Patient has had subsequent visits with Cardiologists who recommended ongoing treatment with anti-inflammatory medications.
muscle ache; fatigue; Chills; little bit fever; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle ache), FATIGUE (fatigue), CHILLS (Chills) and PYREXIA (little bit fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle ache), FATIGUE (fatigue), CHILLS (Chills) and PYREXIA (little bit fever). At the time of the report, MYALGIA (muscle ache), FATIGUE (fatigue), CHILLS (Chills) and PYREXIA (little bit fever) outcome was unknown. Not Provided      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.   Concomitant medication was not reported. Treatment medication was not reported.     Reporter did not allow further contact
local reaction of swelling; also could taste the vax about 5 mins p/inject; irritable in the evening; 7MAY92 f/u phone report, had 3rd dose c/o muscle ache, was pale & pasty & could taste the vax again;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 23-APR-2013 the patient was inadvertently vaccinated with an expired PEDVAXHIB (dose 0.5 ml, intramuscular route) (lot number 0437AA) vaccine that has expired on 09-APR-2013. No concomitant medications were reported. No adverse effects reported. This case is linked to MARRS 1304USA015547 and 1305USA000264. Additional information has been requested.
Raised red rash, small red bumps throughout rash. Rash is roughly the size of a half-dollar. Rash was itching and burning.
Mom called 05/16/05 and reported child had fever of 101 F rectally. 05/13-05/16/05. 05/16/05 had 20-30 Chicken Pox lesions over body- mostly arms and face. Pox starting to dry up 05/17/05. Child seems to be recovering nicely 05/18/05..
NUMBNESS AND TINGLING RIGHT SIDE FACE ULTIMATEL ENTIRE FACE Narrative: MONITORED FOR SEVERAL HOURS WITHOUT PROGRESSION OF SYMPTOMS GIVE 40 MG PREDNISONE PO
Received vaccine on the 19th of August.  On the 20th of August 25 hours later had a stroke.  Flown to  Medical Center.  Left side was left useless.  Can't move arm or leg.  Can't see out of left eye.
Patient was light headed and dizzy almost immediately after injection. She had not eaten so provided patient with orange juice. After 5 minutes or so, patient requested emergency services be called. They cleared the patient, she was not taken elsewhere for treatment.
Pt developed headache a few hours after vaccine that persisted for 3 days despite over the counter analgesics and greatly improved after an IM injection of Toradol 30mg on 1/14/21. Pt also had myalgias and grogginess that was self-limited.
Drug ineffective (tested positive for COVID); Tested positive for COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective (tested positive for COVID)"; COVID-19 (medically significant), outcome "unknown", described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down; The patient experienced on the right leg from the knee to foot was swelling; Feeling as if clot is coming up; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down), JOINT SWELLING (The patient experienced on the right leg from the knee to foot was swelling), COUGH (Coughing) and THROMBOSIS (Feeling as if clot is coming up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 038B71A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included SPIRONOLACTONE and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced COUGH (Coughing). On an unknown date, the patient experienced OEDEMA PERIPHERAL (The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down), JOINT SWELLING (The patient experienced on the right leg from the knee to foot was swelling) and THROMBOSIS (Feeling as if clot is coming up). At the time of the report, OEDEMA PERIPHERAL (The patient experienced on the right leg from the knee to foot was swelling/Swelling of Right leg from Knee down), COUGH (Coughing) and THROMBOSIS (Feeling as if clot is coming up) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: No specific follow-up information recorded. On 02-Jun-2021: Follow up
Bruising/bleeding and pain on both hands. Appears to be ecchymosis. Began 2 days after vaccination.
Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphedema and Breast cancer.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment also included Gatorade.   This case was linked to MOD-2021-162291 (Patient Link).
Suspected vaccination failure; Shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2023 This reporter had a question about one of her patient's with MS (Multiple sclerosis) who appeared to be presenting with shingles despite previously being vaccinated with Shingrix. The reporter shared that the patient had what she thought looked like shingles.  The reporter agreed to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient did not have a reaction until later that night  (after pharmacy closed) with symptoms of lip swelling and sores in mouth. She took benadryl and consulted a nurse practitioner. Patient claims to have received benadryl and antibiotic. Patient did not report these events to the pharmacy until 20 days later.
01/21/22 presents to ED for "worsening shortness of breath and cough". PMHx of "CHF, hypertension."
received only the liquid portion; received only the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMCA602A, expiry date 31st August 2022) for prophylaxis.   On 9th November 2021, the patient received Menveo. On 9th November 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccinaton was not reported. The patient might received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021AMR238864 and US2021AMR238865, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238864:same reporter US-GLAXOSMITHKLINE-US2021AMR238865:same reporter
I have had 4 Shingrix shots yet I still get Shingles. Why?/Suspected vaccination failure; I have had 4 Shingrix shots yet I still get Shingles. Why?; I have had 4 Shingrix shots yet I still get Shingles. Why?; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 4th dose of Shingrix, the 3rd dose of Shingrix, the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, Shingrix, Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix, Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had 4 Shingrix shots yet and he/she still got Shingles. The patient asked why. Additional supportive information: The patient had 4 Shingrix shots, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
pale and slumped over; pale and slumped over; Information has been received from a physician via a field representative referring to a 15 years old male patient. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. The patient had not eaten breakfast on the vaccination date.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R020949 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 04-MAY-2021; route, strength and dose were not reported) for prophylaxis. Other suspect therapy included meningococcal conj vaccine (unspecified) (reported as "MCV4 vaccine") (route, strength, dose, batch/lot # and expiration date were not reported) for an unknown indication on the same date.      On an unknown date, the patient experienced pale and slumped over. The patient was given orange juice.   The outcome of both events was reported as recovered. The causality was not reported.