chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles no bad I got them on the left side of my head; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles on the left side of head. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
A few days after the vaccine pt started to experience dizziness, nausea, vomiting and feeling weak, and then her eyesand her jaw and her face started to twitch and that moved down into her arms and legs muscle spasms and tremors sometimes very severe where she could not walk after her legs were so sore and weak.  Nerve pain and neck pain she started feeling very sick and was in a lot of pain  After dis charged from the hospital a few days after she started feeling sick again, vomiting and weakness and twitching again, the twitching never really went away it's just not as bad when ur first started
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 18-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "23-10pk-0.5ml-SD PFS LLok w Tip" which had a lot number of M005287 and expiration date on 08-OCT-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the PNEUMOVAX 23 had two temperature excursions; one for 32 hours with lowest recorded temperature of 34 F (1.1 celsius) and other one for 24 hours with lowest recorded temperature of 32 F (0 Celsius). The lowest recorded temperature was 32 F (0 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Patients chart was flagging patient needed 3rd dose due to being immunocompromised. Educated patient that he would be getting 3rd dose and why. After administering vaccine and patient leaving it was noted that the chart was flagging for 3rd dose but it had been given previously.
Vaccine was administered on 5/11/2021 but expired 5/6/2021 if you go by the 30 days since we received the vials on 4/6/2021.
Vasovagal syncope.  Immediately after injection pt. felt nauseated and blacked out for about 5 seconds.
Stomach ache- slept  Headache- slept Sore arm- rice pack
vials were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again) 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again).    No concomitant medication was reported.  Nurse reported that 100 bivalent boosters were given a day before reporting from vials that were put in the fridge and after that refrozen and thawed again.  No treatment information was provided.  This case contains information for the 94 of 100 adult male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752: case
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced side effects with the 1st dose of SHINGRIX and those side effects were not specified. For tolerance to 2nd dose of SHINGRIX, refer case US2019GSK025463.
I got COVID and have been sick ever since. Chronic sinus problems and 4 rounds of antibiotics
On 1/6/22 I started having period style cramps and  cramping in the groin area.  I had a hysterectomy 6 yrs ago and have been post menopausal for over 7 yrs.  Advil helps but the pain in the groin area has not subsided.
"Had 2nd dose COVID-19 vaccines on 3/5/21, + nausea, fatigue arm sorenss and swelling"
Severe Headaches, Extreme Fatigue, Ringing in Ears, Nausea, Bitter taste in mouth
Immediately saw sparkles, became dizzy, had poor color and was pale.  Became very hot then cooled about 5 minutes later.  Left clinic. Went to school.  Developed hives.  Developed flu like symptoms.  Fever, leg cramps.  Hospitalized in intensive care with Viral Sepsis. Discharge Summary received states vomiting, chills, rash, hypotension, tachycardia, and viral exanthema.  Follow up 03/07/05:Information on manufacturer, will have to be obtain from another facility. The patient has recovered from the adverse event(s) but states "It was hell".
She started to get a sore throat and drainage the day after the first dose of the vaccine. That day she had headache, sore arm with earache and joint pain. Those symptoms continued for several days with some loose stools which lasted for two to three days with abdominal pain which persisted for a little over two weeks. We visited the doctor because of ear and throat pain and nausea. All tests were negative, but the symptoms improved slowly but they are totally resolved right now.
12 hours after receiving vaccine I got sharp pains in back and legs. Burning sensation all over body. I was walking across my room and passed out waking up on the floor. Muscle cramps and tightness followed this.  I could not move my muscles for roughly 12 hours. After 24 hours from receiving vaccine these extreme symptoms seemed to fade and I was left with fatigue, soreness and fever as expected. This lasted for the next 3 days
Not smelling anything; Dry up sinus; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Not smelling anything) and SINUS DISORDER (Dry up sinus) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ANOSMIA (Not smelling anything) and SINUS DISORDER (Dry up sinus). The patient was treated with PARACETAMOL (TYLENOL) for Sinus disorder and Anosmia, at an unspecified dose and frequency. At the time of the report, ANOSMIA (Not smelling anything) and SINUS DISORDER (Dry up sinus) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 23-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # L007560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
PT REQUESTED US TO REPORT: NAUSEA/VOMITING, EXTREME MUSCLE PAIN, RAISED BUMP GREATER THAN 5 CM THAT APPEARED > 72 HRS FROM INJECTION AND INCREASED IN SIZE OVER TIME INSTEAD OF DECREASEING ,  FEVER OF 98 DEGREES
Patient called 2 weeks after her flu shot to report having had a reaction to the immunization.  She said she had itching, hives and some difficulty breathing.  She stated had had flu shot in past before with no issues.  Stated no allergies to eggs.
Extremely sore arm for 4 days with resolution on the 4th day. 9 days post injection, I developed nausea, slight chest congestion, and 100.0 fever. My Left deltoid where I received initial injection became sore again with sore lymph nodes to the surrounding area. L upper arm warmer to touch than R arm. It is now 1/16/21 and arm still with soreness and still warmer than other arm. No redness or edema noted however.
This spontaneous report as received from a Doctor of pharmacy refers to a 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 23-JUL-2014, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # K000328, expiration date 06-MAR-2015) subcutaneously in the left arm. The pharmacist report that on 25-JUL-2014, the patient sought medical attention at pharmacy by going into pharmacy and stated she experienced headache, felt horrible and had a super, bright red, golf ball size area at her left arm ZOSTAVAX injection site since an unspecified date after the administration of ZOSTAVAX. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Wednesday : No energy,  Chills,  Fever 101.7, degrees,  Injection site swollen and sensitive to touch,    joints & muscle pain all the time,   HEADACHE, left out of it like I had been hit by a truck. Took Tylenol, drank lots of liquids, slept, miserable Thursday:  Chills,  Fever  around 100.8 degrees,  chills,  headache,  some joint and muscle pain,  runny, stuffy nose and some coughing,  Injection site still sensitive to touch and swollen.  Had  a  little energy today. and more aware of surrounds.  Tylenol,  drank lots of liquids,   Firday:  No temperature and feel some better, but still some of all the problems.
The patient had the vaccination given at 10: 30 AM on 2/28/2021 and became lethargic and deliriums at 9 pm. She was alert and oriented to person, place and time at baseline, she became confused, not able to find her words, oriented only to person for 3 days. She presented to Hospital on Tuesday 3/2/2021 and improved with conservative measures on Friday 3/5/2021.
Pt  received FLUMIST.  Epistaxis noted after administration of FLUMIST.  Pressure applied immediately.  Bleeding stopped in minutes.  Pt examined per physician.
Patient received his Moderna Vaccines on 1/15/21, 2/12/21, and 11/2/21. He was admitted to medical facility  for Rehab-on 1/19/22. He tested positive for COVID-19 on 1/20/22. He was asymptomatic. On 1/24/22, patient was found unresponsive in his room. CPR and ACLS was performed but patient could not be resuscitated.
inadvertently administered the vaccines that were stored outside of normal range; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number DE7TB, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd April 2021, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The clinical supervisor called in to check stability of Flulaval vaccine stored at minimum 29 degree F temperatures for 48 hours. The clinical supervisor reported that the patient was inadvertently administered Flulaval tetra vaccine that was stored outside of normal range and needed to be discarded, which led to incorrect storage of drug. The reporter was unable to provide additional details. This case is one of 5 cases,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102718:Same reporter US-GLAXOSMITHKLINE-US2021102717:Same reporter US-GLAXOSMITHKLINE-US2021102720:Same reporter US-GLAXOSMITHKLINE-US2021102721:Same reporter
After I was forced to take the vaccine to keep my job, I had neurological symptoms following the first shot. Following the second shot my whole mouth was filled with cold sores and I got a yeast infection. I continued to have neurological symptoms from the first including left hand tremor, disorientation, forgetfulness, and headaches.
Client reported rapid heartrate, chills, muscle aches, "skin hurt to touch", headache, felt "worn out". Has mitral valve prolapse and is on meds. Has had increased HR before when sick, but this was worse. Had slight increased HR
I still have pain in my left leg; Have kind of muscle pain in my left leg above the knee on the back side; Sometimes my foot starts to sleep like tingling; Sometimes my foot starts to sleep like tingling; 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), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 15Apr2021, for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I still have pain in my left leg"; MYALGIA (non-serious), outcome "unknown", described as "Have kind of muscle pain in my left leg above the knee on the back side"; PAIN IN EXTREMITY (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "Sometimes my foot starts to sleep like tingling". Therapeutic measures were not taken as a result of pain in extremity, myalgia, pain in extremity, paraesthesia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
about 4 - inch area of redness, warmth and induration treated with KEFLEX 500 mg BID x 7d
Pt devl persistent, inconsolable crying x 4.5 hrs; t100.4 R; No treatment;
First dose had a cough for a week and a half, bad breathing, 4 weeks of being tired, after shot had to get COVID testing because she started having symptoms. 3 weeks later got shot two and had a headache for that 3 weeks with no relief.
Increasing Fever and stomach ache during the night.  To 101.2 degrees Farenheit by 8am 02/19/2009.  Patient complained of headache and nausea as well.  Patient vomited at 11 am 02/19/2009.             Fever noted as high as 102.5 degrees Farenheit by 12pm 02/19/2009.                                                                      Patient vomited at 10pm on 02/19/2009.               Patient's average temperature has been above 100 degrees Farenheit.  Her school denies that other children are calling in sick with high fever and vomiting.  Her temp. is now 100.2 and she is complaining of a stiff neck but denies any other listed symptom.  She has not vomited, had a temp. above 101 degrees, complained of headache, stomach ache, or nausea today.  If there is a return of any of those symptoms, we will be going immediately to a Dr. or Emergency Department.  The  vaccine was given at her junior high by the county health department personnel.  It is currently closed for the weekend, so I am unable to get a hold of them until Monday 02/23/2009 to get the manufacturer and lot number.
I tested positive for Covid-19 on 08/16/2021. I first started to feel like I had allergies. I had been outside so I did not think anything of it. A couple of days later I felt tired and I think I was getting a fever. Over the next five days I started to feel worse and I had some nausea. By one week my fever broke and I had scheduled to get a home test. I tested positive. I had severe fatigue for a week with congestion. The congestion seemed to go from one side to the other. My appetite returned gradually. I quarantined for 10 days and when I got tested again my Oxygen level was a little low. It has been three weeks and I still feel a little winded sometimes when I do any activity. I normally go to the gym for two hours every day.
flavors started changing; loss of taste; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old (she just turned 50) female patient received bnt162b2 (BNT162B2), dose 1 on an unspecified date (Batch/Lot number was not reported) as single dose (at age not specified if 49- or 50-year-old), and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 50-year-old for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine included: bnt162b2 (BNT162B2), dose 1 on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient experienced flavors started changing on her and they continued to change, loss of taste on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ear, nose and throat examination: normal.   The course of events was as follows: She started to notice a decrease in her taste after her first dose but it was not much, she was still able to taste salty things but for example she was eating a sandwich and she was not sure what kind of sandwich it was, she was having in and out with salt and sweet. Then she had her second dose and she noticed as time passed that her sense of taste has become less and less and not it was hard for her to taste salt, everything just became dull and duller and duller. She cannot tell if she was eating something crunchy like an apple or a turnip or something.  She went to an ENT on 12May2021as she realized flavors started changing on her and they continued to change and they put a tube up her nose and into her ears and said that visually everything looked normal and that there did not appear to be any cause for this loss of taste upon their exam. Now, it was hard to decipher to her what she is eating.  She was concerned. The doctor said they are going to give her some vitamins and see if it helps. They asked if she had been vaccinated and when she said yes they told her to contact Pfizer as Pfizer would know more information that they did because the doctor said it was not on side effects listed. She wished to know if this has been reported and queried how long can this side effects last and if it is temporary. She stated no misconduct was done in administering the vaccine.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
administered 1ml to five patients; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1ml to five patients) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (administered 1ml to five patients). At the time of the report, ACCIDENTAL OVERDOSE (administered 1ml to five patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Corrective treatment was not reported. Reporter did not allow further contact.; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273 with no associated AEs.
PATIENT WAS SCHEDULED TO RECEIVE 2ND DOSE OF MODERNA MONOVALENT 6MO-5YEAR AND INADVERTENTLY RECEIVED MODERNA BIVALENT 6MO-5YEAR AS THEIR 2ND DOSE.