chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 10-MAY-2012, the patient was administered with a dose of VARIVAX (merck) (Lot # 1909AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 13-JUL-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K023534 and expiration date 22-MAY-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
SAT 4PM mom checked temp - 102.6 c/o hurting all over & headache.Taken to ER; MD said tonsils were red gave Amoxicillin to take 1 tsp TID & Tylenol q 4 hrs. Saturday nite temp to 103 c/o eyes burning & Sunday better still had low grade temp
have seizures is gut wrenching; This spontaneous report was received from a consumer referring to a male patient of unknown age. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.   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) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis.  The reporter stated that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) has altered the patient's life irrevocably. The reporter was guilt for allowing pediatrician to give the patient that shot. In 2014, the patient started having seizures. The event of seizures caused hospitalization. The reporter did not inform Merck at the time. The reporter stated that the patient was up to date on vaccines, including the meningitis shot. The reporter stated that human papillomavirus (HPV) was a sexually transmitted disease that could be detected and treated. Limiting sexual partners (what a novel idea!) and having regular physicals and living in a healthy way was so much more sensible than injecting this poison. The healthy young patient had his dreams of playing college sports and going away to college stepped on due to unexpected, vicious seizures was not how preventative medicine was supposed to work. The patient was strapped to electroencephalogram (EEG)s waiting to see if a seizure happens, paid over $1800 out of pocket with insurance just to drive him 2 blocks from the emergency room (ER) to the best epilepsy unit, paid $1000/month for a name brand medication that worked the best because insurance won't pay because "there was another anti-seizure medication, just use it". The reporter stated that the healthy, smart young man was a victim of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The reporter wished that Merck would take that money and help some family that has also been damaged by hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Medical attention was sought. Treatment was given to the patient. The outcome of the event was unknown. The causality assessment was related.  Upon internal review, the event of seizure was determined to be medically significant.
Injection hit nerve; Pain in arm; Stinging; Tingling in shoulder blade and neck; A spontaneous report was received from a consumer concerning herself, a 71-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain, injection hit nerve (wrong injection technique), stinging, and tingling in shoulder blade and neck.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 013M20A) in the left arm for prophylaxis of COVID-19 infection.  On 03 Feb 2021, after the vaccination, the patient experienced arm pain, injection hit nerve, stinging, and tingling in shoulder blade and neck. The patient was concerned that the shot was not administered properly. Treatment information included tylenol.  Action taken with mRNA-1273 in response to the events was unknown.    The outcome of the event, injection hit nerve (wrong injection technique) was considered as recovered on 03 Feb 2021. The outcome of the events, arm pain, stinging, and tingling in shoulder blade and neck, was considered as unknown at the time of this report.; Reporter's Comments: This case concerns a 71-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot # 004M20A), reporting that wrong technique in product usage process with injection that hit a nerve with associated adverse events of unexpected pain, paresthesia and expected injection site pain. The events occurred the same day as first dose mRNA-1273. Treated with Tylenol. Adverse event outcomes unknown.
Pt reported hx of vasavagal. Client fainted for 25 seconds and threw up within 5 min. The pt threw up again 50 min later and felt better and less dizzy. Pt left facility in stable condition 70 min later.
red face; tingly lips; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red face) and PARAESTHESIA ORAL (tingly lips) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (red face) and PARAESTHESIA ORAL (tingly lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Mar-2021, ERYTHEMA (red face) and PARAESTHESIA ORAL (tingly lips) had resolved.        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 provided by the reporter.
Intermittent itching and rash starting the day after receiving the vaccine.   No shortness of breath, wheezing, lip/tongue swelling, vomiting, or diarrhea.
GUILLAIN-BARRE SYNDROME; GOT OUT OF BED ONE NIGHT AND HIT THE FLOOR; DEATH; This spontaneous report received from a consumer via a company representative through social media concerned a 7 decade old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was perfectly healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 7 decade. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-barre syndrome, and was hospitalized (dates unspecified). The number of days of hospitalization was not reported. On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. It was reported "My very best friend in the world could not wait to get the covid vaccine back in 2020. She had to wait until her age group was available, she was 63. She was finally okayed. About two weeks later she got out of bed one night and hit the floor. Her legs were paralyzed. After finally going to a few doctors she was hospitalized. Many tests later she was diagnosed with Gillian Barre' Syndrome. After living a nine month nightmare she passed away. J.and J.was contacted but nothing was done. A perfectly healthy woman went to a bedridden person who was sick everyday for the remainder of her life. So,so sad." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain-barre syndrome and got out of bed one night and hit the floor was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case is a duplicate of 20221240094. This case, from the same reporter is linked to 20221245268.  It was determined that Manufacturer Case Number 20221240094 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20221237321.; Sender's Comments: V0: 20221237321- Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  V0: 20221237321- Guillan-Barre syndrome. The event has a unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.  V0: 20221237321- Got out of bed one night and hit  the floor- The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
About 10 minutes after the shot, my chest felt very hot and spread to both my left and right arm down to my elbows. Simultaneously, I experienced a weird taste in my mouth that was not metallic. My heart rate increased. I sought help immediately. My chest was a bit painful. That subsided a bit and then both arms felt tingly from my elbows to my wrists. That subsided and came back, milder each time. This lasted for about 50 minutes before I was allowed to leave and go home. I am typing this 7 hours later and my tongue feels a bit swollen (not unusual based on my food allergies and am not concerned to go to the hospital), and my chest still hurts a bit. I am wondering if it's anxiety at this point. My breathing and speaking have been totally fine. I got home with no trouble. I rested for several hours just to make sure I did not overexert myself.
Patient developed a circular/ovoid area of erythema, edema and pain distal to the injection site.
Full blown cold; Sniffles; Dry cough; Arm soreness; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Dry cough), PAIN IN EXTREMITY (Arm soreness), RHINORRHOEA (Sniffles) and NASOPHARYNGITIS (Full blown cold) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 031M20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included Mouth cancer, Tongue neoplasm NOS, Knee replacement (Total right knee replacement surgery) and Radiation therapy. Concurrent medical conditions included Type 2 diabetes mellitus and Loss of taste.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm soreness). On 23-Sep-2021, the patient experienced COUGH (Dry cough). On 24-Sep-2021, the patient experienced RHINORRHOEA (Sniffles). On 27-Sep-2021, the patient experienced NASOPHARYNGITIS (Full blown cold). In September 2021, PAIN IN EXTREMITY (Arm soreness) and RHINORRHOEA (Sniffles) had resolved. On 24-Sep-2021, COUGH (Dry cough) had resolved. At the time of the report, NASOPHARYNGITIS (Full blown cold) had not resolved.            No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-042571 (Patient Link).
Moderna Covid Vaccine administered to 17 year old. Currently this vaccine is only approved for 18 years and up.
This spontaneous report as received from a registered pharmacist refers to an infant patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 03-OCT-2014 the patient was vaccinated with RECOMBIVAX HB (dose, dose number, lot number and expiration date were not reported). Co-suspect and concomitant therapies were not reported. On 04-OCT-2014, the patient received another dose of the vaccine. No adverse symptoms reported. Additional information has been requested.
1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches, lump in armpit.  *First dose; slight fever of 100 on day 3,4 and pain at injection site.
Initial case received from a health care professional on 29 September 2009.  This is a case involving a non-recommended site and route of administration.  A 47-year-old female patient, with a history of hypertension and overweight, experienced a red, tender area at the injection site after receiving a subcutaneous left buttock injection of ADACEL (C3355AA) on 24 September 2009.  It is recommended that ADACEL be given intramuscularly in the deltoid area.  According to the reporter, the vaccine was given intramuscularly, but the patient was very large, which resulted in a subcutaneous administration.  Approximately eight hours post-vaccination, the patient complained of her buttock being sore, with redness the size of a half-dollar noted at the injection site.  She was seen by her health care provider on 29 September 2009, at which time there was a 12-15 cm area of erythema which was tender.  The patient also complained of pain radiating to the abdomen.  At the time of the report, the events were ongoing. Follow up information received on 20 November 2009 from a health care professional. The patient did not require further treatment. The patient recovered. Follow up information was received from the health care professional on 23 November 2009.  The patient was treated with Ibuprofen, and the event recovered after a "few days".  No additional information was reported.  Documents held by sender:  None
Edema > 10cm of arm with induration and erythema. ( Encompassed >2/3 of upper arm ).
Vaccine given at 8am on 09/27/2005. On 09/28/2005 at approximately 1am developed soreness at injection site profuse diaphoresis and muscle weakness in both legs. Continued throughout day until 09/29/2005 am when he felt no further symptoms.
On 11/08/2021 I hit my left ankle with my right foot, and it was sore, I felt it with my hand, and it was sore. On 11/09/2021 I did not do my normal activities/exercise because I had thought that I had pulled a muscle. I called my doctor and went to see him on the 11/10/2021, Two clots were found in my left leg. (DVT clot) I am now on Xarelto, 15mg twice a day (21day), 20mg once a day on 22 till my Dr appt, then I have a prescription for 20mg once a day till I visit my doctor again in February.
I had a left trochanteric bursitis in my left hip. It caused severe pain and inability to stand. I was given prednisone dose packs initially. When that didn't work, I received a steroid injection in that hip. When that continued, I went to the emergency room in the beginning of august and that is where I was diagnosed with an acute renal injury. They thought it was from ibuprofen I was taking with the prednisone. I was in the hospital for two days to drop my creatinine and bun levels. After two days I was discharged after my numbers came down. I was referred to a nephrologist. With subsequent blood work my numbers went back to normal at the beginning of September. During this time my parathyroid and calcium were elevated. I am a seeing an endocrinologist to see if I have hyperparathyroidism.
Second dose that made him pretty sick.; This is a spontaneous report from a contactable consumer. A 52 years male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single Dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single Dose for covid-19 immunisation. The patient experienced second dose that made him pretty sick on an unspecified date. Caller stated what does it mean that vaccine may not protect everyone. Caller wanted to know if the second dose is same as first dose. And also ( 78 years old female) stated she received the first dose of the Pfizer covid vaccine on the Feb 25 and her second dose is scheduled on the March 25, 4 weeks later instead of the 3 weeks later. Caller stated the first dose did not bothered her but she wanted to know if its ok to take it 4 weeks later then the 3 weeks later and wanted to know if she experienced headache after the second shot can she take Tylenol for it. Caller stated her doctor told her that the first dose of the covid vaccine caller was not sure if that was Pfizer or moderna made him a little bit sick but its the second dose that made him pretty sick and also there is another male patient 52 years old stated the covid vaccine made him a little bit sick and more on the second dose caller was not sure if that was Pfizer or moderna. Several other people told her that the first dose did not bother them but they felt sick with the second dose caller was not sure if that was Pfizer or moderna. The events were assessed as Non serious by health authority. The clinical outcome of the event second dose that made him pretty sick was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a healthcare worker, via field employee, refers to a 10 year old male patient. The patient's current conditions and medical history were not reported. On approximately 03-JUN-2015 (reported as 2.5 weeks ago), the patient was vaccinated with GARDASIL. Concomitant medications were not reported. Four days later, on approximately 07-JUN-2015, the patient found that he "had no feeling below his navel". The outcome of the event was unknown. The patient's physician stated that the event was vaccine related, and hence related to GARDASIL use. There was no product quality complaint involved. Upon internal review, the event was considered serious due to possible disability. Additional information has been requested.
flu symptoms; fever; chills; body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 017B21A and 048F21A) 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 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). In 2021, INFLUENZA (flu symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.            Patient never had COVID positive test or diagnosis.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  After the primary series and first booster, the patient experienced flu symptoms like fever chills and body aches during 3 or 4 days.  The patient did not take any treatment.   This case was linked to MOD-2022-662419 (Patient Link).
I have pain in lower left leg, back side feels like somebody kicks me. It''s a real localize pain about 5-6 Inches up from the ankle.; I am a little tightened the chest for breathing, It is not extreme or anything but I do notice it breathing.; Off-label use; booster; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE3592), via an unspecified route of administration, administered in Arm Left on 01Oct2021 (at the age of 60-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation and received influenza vaccine inact split 4v (FLUZONE QUADRIVALENT) taken for an unspecified indication from 29Sep2021 to 29Sep2021. Medical history included Lyme disease, chronic pain. Concomitant medication(s) included hydrocodone and morphine. The patient previously received bnt162b2 dose 1 and dose 2 on an unspecified date for covid-19 immunisation and the patient reported having swollen testicles and the couple other issues (Further not clarified) after dose 2. The consumer stated that his left leg lower cap from back side feels like somebody kicks him in his sleep and little tightened the chest for breathing. It was not extreme or anything, but he did notice that breathing. He was having pain in lower left leg, back side felt like somebody kicks him. It was a real small localize pain about 5-6 Inches left from the ankle. The patient underwent lab tests and procedures which included blood oestrogen: unknown results, c-reactive protein: unknown results, full blood count(Hemogram): unknown results, haemoglobin: unknown results, immunology test (western blot line test): unknown result, investigation (Lyme test ): unknown results, lipids panel: unknown results, metabolic function test: unknown results, polymerase chain reaction: unknown results, red blood cell sedimentation rate (ESR): unknown results, sars-cov-2 test: unknown results, thyroid function test: unknown results, all tests on 29Sep2021. The patient did not receive any treatment for adverse events, he stated he has not taken anything since his 4 O clock morphine dose. He takes a bunch of supplements for his Lyme disease but did not take any supplement today (Further clarifications unknown). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101308580 same patient/drug, different dose/event