chrisvoncsefalvay/vaers-outcomes huggingface dataset:
both Vaxelis and Pentacel was given to patient at 2 month visit by nurse with no reported adverse event; Initial information received on 04-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2022SA321965(CLUSTER).  This case involves a 2 months old patient of an unknown gender and it was reported that both Vaxelis and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given to patient at 2 month visit by nurse with no reported adverse event .  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], (lot number and expiry date: not reported ) via unknown route in unknown administration site for  prophylactic vaccination (immunization) and also received an unknown  dose of suspect VAXELIS not produced by Sanofi Pasteur, ( lot number and expiry date: not reported) in unknown administration site. for prophylactic vaccination (immunization)  It was reported that both Vaxelis and Pentacel was given to patient at 2 month visit by nurse with no reported adverse event (extra dose administered) (latency: same day). It is unknown if there were lab data/results available  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 guidelines. 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 spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information about the patients medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L032391, expiration date: 26-AUG-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. There was no adverse event reported. This is one of two reports received from the same reporter. Additional information has been requested.
Mom states after 2 month shots were given on 12/8/05 baby cried for 3 hours straight.
At 7:00pm felt  like I would faint & nauseated. Blood pressure 96/57. Laid down & drank a ton of  fluids. Bp came up after 45 min. Felt extremely nauseated, dizzy, sick, nose ran constantly, weak, lethargic, shaking chills for 4 hours. During that time, continued to feel faint, chills, weak & very nauseated. Extremely restless. Temp with ear thermometer was 98.4. Never vomited. Around 11 pm I began feeling better.
The next day the lymph node underarm is swollen. On 10th day, my left boob is swollen, and tender and painful. left Shoulder blade, underarm l,left chest very painful
After 9 days I got a rash about two inches longer and an inch wide at injection site
Stood up, sat down and got light headed before blacking out. Nurses on-site said I had a seizure. Rushed to hospital. Blacked out for 1.5 minutes
This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 30-DEC-2016, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection (lot # M031557, expiration date: 07-APR-2019) for prophylaxis (strength and route was not provided), rather that the intended VAQTA, due to human error. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Two days after vaccination, erythemateus induration on left arm and then diffuse pruritic maculopopular, some pin-point areas of erythema-trunk mild, extremities, palms and soles. No fever and no respiratory problems.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. Approximately on 14-MAY-2015 (yesterday) the patient was vaccinated with improperly stored LIQUID PEDVAXHIB VIAL WET SD (lot# K025066 and expiration date 02-JUL-2017) 0.5 ml, intramuscular. No adverse events reported. Additional information has been requested.
Patient reports that starting on the day of the vaccination, she had a fever as well as pain in both of her legs and pain in both of her arms. The pain in her legs and arms is still ongoing and she reports that her arms feel very heavy and that it is difficult to use them.
Lack of efficacy; Sleeping a little longer than usual; She had aches and pains (joint); She had aches and pains (muscle); Felt very bad; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy), HYPERSOMNIA (Sleeping a little longer than usual), ARTHRALGIA (She had aches and pains (joint)), MYALGIA (She had aches and pains (muscle)) and FEELING ABNORMAL (Felt very bad) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced ARTHRALGIA (She had aches and pains (joint)), MYALGIA (She had aches and pains (muscle)), FEELING ABNORMAL (Felt very bad) and CHILLS (Chills). On 14-Aug-2021, the patient experienced HYPERSOMNIA (Sleeping a little longer than usual). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy). On 17-May-2021, ARTHRALGIA (She had aches and pains (joint)) outcome was unknown, MYALGIA (She had aches and pains (muscle)), FEELING ABNORMAL (Felt very bad) and CHILLS (Chills) had resolved. At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and HYPERSOMNIA (Sleeping a little longer than usual) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         She received her first dose of Moderna covid-19 vaccine on 14-APR-2021 with lot no.007B21A No concomitant medications reported. Patient took advil at 12th hour of 15-APR-2021 and 3 times after.  Company Comment: This is a case of Drug ineffective with associated adverse events and Patient tested positive for COVID-19 after receiving 2 doses Moderna vaccine in the correct interval (25-35 days).  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing  COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, of Hypersomnia, Arthralgia, Myalgia, feeling abnormal and Chills, a causal relationship cannot be excluded.; Sender's Comments: This is a case of Drug ineffective with associated adverse events and Patient tested positive for COVID-19 after receiving 2 doses Moderna vaccine in the correct interval (25-35 days).  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing  COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the events, of Hypersomnia, Arthralgia, Myalgia, feeling abnormal and Chills, a causal relationship cannot be excluded.
PATIENT ENDORSES A TOPICAL "KNOT" HAS DEVELOPED AT INJECTION SITE (LEFT DELTOID). AFFECTED AREA HAS INCREASED IN SIZE SINCE  DATE OF VACCINE ADMINISTRATION.  SITE REMAINS TENDER W/ TOUCH.  NO ERYTHEMA.  ENDORSES A FEVER DEVELOPED "SEVERAL DAYS" FOLLOWING INJECTION AND IS NOW RESOLVED.    PT REPORTS SHE HAS RECEIVED TETANUS/DIP/PERTUSSIS VACCINE 10 YEARS AGO WITHOUT ISSUE.
Pt experience dizziness & temporary blindness post vaccination. BP 88/56; HR 73; RR 17.  Rechecked BP 10 min later 97/68; HR 72; RR 16. Pt was stable & released from vaccination site
Patient started to develop nausea and a headache about 10 minutes after vaccination. About 15-20 minutes after vaccination, she complained of shortness of breath and difficulty swallowing. 0.3mg epi administer and patient sent to the hospital.
Vaccine administered at school clinic, 11/6/09, at approximately 6:50 PM. Mother noticed a few hives on several parts of childs body at 7:30. Called her MD - gave Benadryl and advised by physician to take Zyrtex. Parent called school today (11/9/09). Adivsed not to get 2 vaccine.
The day after the injection, I experienced sweating, chills, fever,  weakness, stomach upset, nausea and headache. Fell from weakness.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: fingers tingling-Medium, Additional Details: pt complained of chest pain after injection & tingling in fingers-bp was taken-143/82 -called  911 & they checked her out in ambulance-paramedics released her a few minutes later to go home
Pt received both doses of vaccine and has tested positive for COVID-19 on 3/9/21 via PCR testing.  Pt initially asymptomatic and reports no complaints.  VS: T 97.9, P 60, BP 144/84, R 16, O2% 99 today. Pt afebrile since positive test results obtained and had c/o headache on 3/9/21 with reported relief from Ibuprofen.
Jittery; Feels worse today than last Saturday and Sunday; nervous; Teeth, head, & ears hurt, headache; Nauseated; Body aches; Bloody mucusy diarrhea; Stomach cramps; Low-grade fever (100F); Bad chills during the night; Could not sleep; A spontaneous report was received from a consumer concerning a female patient who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Stomach cramps, Bloody mucusy diarrhea, Bad chills during the night, Could not sleep, Low-grade fever (100F), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse,nervous and headache.   The patients medical history was not provided.No relevant Concomitant medications were reported.  On 03 mar 2021,prior to the onset of events, the patient received her first of two planned dose of mRNA-1273(Lot number: 014M20A) vaccine intramuscularly in the upper left non-dominant arm for prophylaxis of COVID-19 infection.   On 05 mar 2021, about 48 hours later, patient developed stomach cramps and bloody mucusy for 24 hours then stopped. Had chills, during the night, could not sleep, and a low grade fever (100F)  at about 11:30 am.  On 09 mar 2021,patient had low grade fever of 99.8F with body aches and headache,nauseated, teeth, head, and ears hurt. Patient reports feeling jittery and nervous and felt worse.Treatment for the event included Extra Strength Tylenol and Probiotics.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The events Stomach cramps,  Bloody mucusy diarrhea, chills, fever,and could not sleep were considered resolved.  The outcome of the event Low-grade fever (99.8), Body aches,nauseated, Teeth, head, & ears hurt, Jittery, Felt worse ,nervous,headache was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
tested positive for COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of CORONAVIRUS INFECTION (tested positive for COVID) 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 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CORONAVIRUS INFECTION (tested positive for COVID). At the time of the report, CORONAVIRUS INFECTION (tested positive for COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. Patient stated that- patient got the vaccine on 8/12 and tested positive for Covid on Monday could it be a false positive?; Sender's Comments: Based on the information that the vaccine does not include virus capable of transmitting COVID-19, the event is assessed as not applicable.
Chronic diarrhea since about a week after the first vaccine. It's been two months now, and no relief.  I just saw a NP this week about it. Also, one week after the 2nd Pfizer injection, I had a headache all day (very unusual for me) and felt strange, not well, weird, had to go to bed at 6:30 pm because I just felt flu like symptoms. I slept all night and was fine the next day, accept for the diarrhea.
One hour after my 2nd vax on April 22, I experienced hearing loss in my right ear. I could only hear muffled sounds. This loss of hearing lasted nearly  24 hours and has appeared to have returned to normal.  After the subsequent loss with my 2nd vax, I realized that I exhibited the identical symptoms, hearing loss in the right ear after my 1st vax on March 25th. On March 28, nearly 3 days later, I exhibited an identical loss of hearing in my right ear. Both events seemed to be triggered by a sudden loud noise. One moment hearing was fine and the next, like a switch was turned on,  the hearing loss came on abruptly.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, IRBESARTAN and ATORVASTATIN for an unknown indication.    On 18-Mar-2021, 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 (Sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of couple of motrin. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-405832, MOD-2021-405834 (Patient Link).
Headache, HTN exacerbation, tachycardia, injection site redness and pain
On December 14, 2021, I gave the patient his second dose of the Pfizer vaccine 7 days early, after the child had received his first dose of the Pfizer vaccine on November 30, 2021. The patient was observed for 15 minutes after the second dose was received and no adverse reactions were noted. It was found around 4:30 pm that the vaccine dose was given at the incorrect interval. I have attempted to contact the parents to inform them of the error but voicemail stated they would be on vacation and not able to check their voicemails.
Swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling on the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling on the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Employee developed redness surrounding injection site, redness started to spread. 11/15 incident reported- given rx for antibiotic
About 30 min after the spray was given, started to get nausea, then a severe in head ache,  with a temperature of 100 degrees. Then started to vomit about a hour. After that my throat started hurting then I got very severe muscle and total body aches. I completely lost my voice. This all lasted about 5 days so far. I lost 5 days of work and I still haven't fully recovered yet! I couldn't go to the doctor or the hospital because I just can't afford it.
Varicella given in right arm 10/19/2001. On 10/22/2001 mom returned with child. Right arm swollen, large red area, warm to touch. Child complained of itching, no pain.
Slept a lot, harsh screaming, not alert, not playful, loss of appetite, staring off. Received medical records from PCP. Received ER medical records which states that patient arrived in full arrest & was unable to be resuscitated. Autopsy Report received which stated that patient experienced SIDS.
Patient received vaccine 12/7/04 am. Developed swelling and redness right arm around injection site that evening. Went to ER and placed on Keflex. Then on 12/8 area getting bigger went to walk in clinic Keflex. Discharged , prednisone started.
Five days after receiving my first dose of the Moderna vaccine, I experience some numbness in the 4th and 5th fingers of my left arm, which was the arm of injection.  I also experience the beginnings of a strange metallic taste in my mouth.  Sort of an iron/zinc/copper taste in my mouth that tainted the flavor of the morning cup of coffee and the other things I ate.  I thought it might be something wrong with me -- like some sort of cancer or something, but saw that others had experience the same symptom.  The taste sensation disappeared on 5/10/2021, a month after my second dose of my COVID-19.  I am still am experiencing episodic numbness in the 4th and 5th fingers on my left hand.
diarrhoea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhoea) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIARRHOEA (diarrhoea). On 17-Mar-2021, DIARRHOEA (diarrhoea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.     Reporter did not allow further contact
Extreme migraine headache lasted for 3 days, nausea, joint pain, body aches, brain fog
Observed redness/hives/swelling on site injection arm; advised LVN; LVN phone-consulted her supervisor who advised taking/administered 2@ Loratadine. Rash subsided (90%) by 3:00pm 03/26/21. Vitals monitored; BP observe out of range (high); o2 saturation  98 and 99. Pulse elevated. Temperature normal: 98.6. Closely monitored for 3 hours (BP, temp, O2, pulse, temperature) until BP was within normal range, then released. Patient observed headache beginning 3:20pm (03/26/21), continuing on thru Saturday night. No headache 03/28/21. Headache and slight nausea beginning 5:00am 03/29/21 and continuing; normal temperature.  Arm soreness above vaccine site location beginning 03/27/21 thru 03/28/21. Ice applied.
This case was reported by a physician and described the occurrence of muscle weakness in a 19-year-old female patient who received BEXSERO (batch number 153701, expiry date April 2017). Co-suspect products included FLUARIX QUADRIVALENT (batch number 9D325, expiry date 15th June 2017). Concurrent medical conditions included insomnia. On 3rd October 2016, the patient received BEXSERO (intramuscular) and FLUARIX QUADRIVALENT (intramuscular). On 4th October 2016, 1 days after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced muscle weakness (serious criteria clinically significant/intervention required), fever and chills. In October 2016, the outcome of the muscle weakness, fever and chills were recovered/resolved. The reporter considered the muscle weakness, fever and chills to be possibly related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were reported as follows: The patient did not have any known allergies and her concurrent condition included insomnia which was ongoing at the time of reporting. The patient received both BEXSERO and FLUARIX QUADRIVALENT vaccines in her right deltoid. The patient experienced weakness of right arm and leg. Multiple attempts were made to communicate with the patient to check the status but no call back was received till the time of reporting. The events were not result of suspected transmission of an infectious agent via medicinal product. The patient did not have any diagnostic tests details which were performed.