chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have not have a normal bowel movement; Random nose bleed almost dails /She stated it was horrific; Chills; Slight Fever; Fatigue; Sore arm; Weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weak), BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement), EPISTAXIS (Random nose bleed almost dails /She stated it was horrific), CHILLS (Chills) and PYREXIA (Slight Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 939904, 036B21A and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced ASTHENIA (Weak), CHILLS (Chills), PYREXIA (Slight Fever), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement) and EPISTAXIS (Random nose bleed almost dails /She stated it was horrific). At the time of the report, ASTHENIA (Weak), BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement), CHILLS (Chills), PYREXIA (Slight Fever), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and EPISTAXIS (Random nose bleed almost dails /She stated it was horrific) had not resolved.            No concomitant information was reported. Patient height was reported as 5.6 or 5.7 F. Patient was neither tested nor diagnosed with COVID and had no acute and chronic illnesses at the time of vaccination. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient was still taking medication at the time of reporting. No treatment information was provided.   This case was linked to MOD-2022-594157 (Patient Link).
The technician was under the impression that you added 1.8 ml of diluent (NaCl 0.9%) to the vial prior to drawing up each 0.3 ml Pfizer dose.  She added 1.8 ml of diluent to the non-punctured vial and drew up the first dose correctly.  She then proceeded to add another 1.8 ml to the same vial and drew up dose #2, which was administered to a different patient.  She then added another 1.8 ml to the same vial and drew up dose #3, which this patient ended up receiving.  The patient received a dose that had been over diluted with NaCl (a total of 5.4 ml of diluent had been added to this vial prior to drawing up that 3rd dose).  We contacted Pfizer to seek guidance on an administration error and to clarify if another dose was to be given.  The representative informed us that Pfizer did not have any specific guidance other than the recommendations outlined by Agency for administration errors, which outlined that doses administered with diluent volume greater than 1.8 ml do not require the dose to be repeated.  This was the patients first dose, so the patient will receive their second dose at the recommended interval of 21 days as outlined in Agency recommendations.
Patient developed facial swelling on the left side of his face on 08/18/21. He was taken to facility in the area. There is was diagnosed with parotitis and prescribed cephalexin. He was seen in our clinic on 08/20/21 for a follow up exam His medication was changed to Augmentin.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 10-APR-2017, the patients were vaccinated with improperly stored doses of M-M-R II which had the lot numbers reported as N010246, expiration date 25-SEP-2018, and N008825 expiration date 12-SEP-2018, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 35°F and the higher was 48°F for 68 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA012767: US-009507513-1709USA012769: US-009507513-1709USA012770: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012768:
10/25--cough and runny nose 10/26--shortness of breath (today) seemingly associated with stuffy nose.  Very weak, much worse than baseline.  Granddaughter-in-law says that she was having hard time even moving her feet after she stood up.  At baseline she needs help getting out of a chair and is standby assist for walking.  No falls as the granddaughter in-law studied her.  Eating well.  Granddaughter lawn notice that she seemed to have trouble breathing this morning.  She asked the patient if she wanted the doctor called and the patient said no, called the ambulance --so they did.   ER:  37.2, 87, 20, 190/71, 96% room air.  COVID test positive.  CMP, CBC normal.  CXR:  NAD.   Patient is being admitted observation for profound weakness.  Granddaughter in-law adamantly opposed to Remdesivir.  Does not believe she has COVID in asked for 2nd test.   ROS:  10 point review of systems negative except as outlined in history of present illness   Exam 37.2, 58, 16, 156/60, 94% room air General:  WDWN, NAD. HEENT:  EOMI, PERRLA, TMs intact, septum midline, oropharynx w/o erythema or exudate, MM moist. Neck:  no masses, JVD, bruits, thyromegaly Heart:  RRR, no S3/S4/m Lungs:  CTA, no rales, ronchi, wheeze Abd:  Soft, NDNT, no G/R/R/M/B  No organomegaly Ext:  No C/C/E Neuro:  CN 2-12 intact, No focal deficites Psych:  Calm, cooperative Skin:  no rashes or open sores MSK:  Generally very weak.  Cannot sit forward in bed w/o assisstance.  Can lift legs off bed about 1 inch.  Dorsi- and planrarflexors are 5/5, though.  Grips 5/5.   Labs:  Reviewed   CXR:  Moderate cardiomegaly with LV configuration.  Indistinct hila and mild chronic disease.  No consolidative opacity, pleural fluid or pneumothorax.  Degenerative changes of the shoulders and spine.   IMPRESSIONS/PLAN   1. Profound weakness.  Obtain film array, UA, PCT, magnesium.  PT/OT evaluations.   2. Rapid COVID test positive.  Not hypoxic.  CXR does not show GGO.  Sx day #2.  Will obtain film array as family requests repeat test and to r/o other viral illnesses.  Introduced monoclonal antibodies to the patient.  We will rediscuss if the 2nd test is positive.  Discussed Remdesivir.  I do not think the granddaughter-in-law changed her mind. Moderna vaccine 2/10/21 and 3/10/21.     3. CAD.  Continue aspirin, statin, beta-blocker, Imdur.  Lexiscan Myoview 2016:  No ischemia, old apical inferolateral infarct.  Echo 2016:  EF 60%, mild concentric LVH, diastolic dysfunction, LA mildly dilated.  I cannot find a heart cath anywhere, although Epic states she had a heart cath with a stent at some point in time..   4. HTN.  Coreg 6.25 mg 2 times a day, Imdur 30 mg daily   5. Chronic pain.  Tylenol 500 mg 3 times a day.   6. GERD.  Protonix 40 mg daily.   7. Tremor.  Mysoline 100 mg a.m., 150 mg bedtime   8. Chronic constipation.  MiraLax 17 g 2 times a day.   9. Hypothyroidism.  Synthroid 88 mcg daily.  TSH 5/8/2021 normal.   10. Anxiety/depression.  Effexor XR 150 mg daily, does a role 100 mg at bedtime.   11. History of vascular dementia (per chart.)  Patient is her own decision maker.       DVT Prophy:  Lovenox Code Status:  DNR
Dizziness -- also experienced with first dose. Observed for 30 min. Stable, released.
Lot expired 12 hour ago- no adverse reaction.  Patient notified on same day.
Localized redness hardness at L upper deltoid sit of vaccine. Dx otitis media, URI 5/10/01.
On date of injection and for 3 days:     chills, fever, body aches (especially joints), dizzy episodes,  swelling under arm; injection site pain with red and itchy rash encircling arm 3  by 3 inches in size
felt a little bit dizzy and light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROBIOTICS; DIGESTIVE ENZYMES; CALCIUM; CALCIFEROL VIT D.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt a little bit dizzy and light headed".  Additional Information: Patient stated that she had experienced inflammatory issues before, such as having a severe allergic reaction to the flu vaccine and other vaccines. She has been taking probiotics, digestive enzymes, calcium, vitamin D to boost her immune system and anti-inflammatories as needed prior to the vaccination. She had since stopped taking them after the first dose of the Pfizer BioNtech COVID-19 vaccine. She also states that she and her husband, 57 years old, felt a little bit dizzy and lightheaded after taking the first dose of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 8/1/99, the pt developed an injection site reaction characterized by a 2 cm by 3 cm area of induration, erythema, and warmth. The injection site drained 3 cc of sterile pus. The pt was treated with an antibiotic.
Breakthrough case admission after 4 vaccines Pfizer 1/28/21 lot# EL9265;  Pfizer 2/18/21 lot# EN6200;  Pfizer 10/7/21 lot# 30155BA;  Moderna 4/21/22 lot# 002M21A
Immunizations adm. about 4 PM. Parents noted child red skin, itching, scratchy throat and chills and presented to the office. He was dazed, throaty, pruritus but ///. Given dexamethasone 4mg and Benadryl 25mg for acute symptoms. Completely improvement in 2 items. Had ///. Placed on Orapred for 48 hours.
Sudden onset (not gradual) bilateral hip joint pain with standing from a sitting position and with walking  . . . . I had never had similar pain before this time. The joint pain has been ongoing for 3 1/2 weeks and has not subsided with rest.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a 85-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included triamcinolone acetonide unknown for an unknown indication and triamcinolone acetonide cream for an unknown indication. The patient's past medical history included bruising of leg (Prior to getting the 2nd dose he had fallen several days before). Concurrent medical conditions included sulfonamide allergy. Concomitant products included liquid paraffin + wool fat (Lubriderm). On 10th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) and triamcinolone acetonide at an unknown dose and frequency. In October 2018, the patient started triamcinolone acetonide at an unknown dose and frequency. On 11th October 2018, 1 days after receiving SHINGRIX and triamcinolone acetonide, 1 day after starting SHINGRIX and triamcinolone acetonide and not applicable after starting triamcinolone acetonide, the patient experienced erythema and pruritus. In October 2018, the patient experienced pruritus aggravated. The patient was treated with benadryl (nos) (Benadryl). Triamcinolone acetonide was discontinued (Dechallenge was unknown). Rechallenge with triamcinolone acetonide was unknown. Triamcinolone acetonide was discontinued (Dechallenge was unknown). Rechallenge with triamcinolone acetonide was unknown. On an unknown date, the outcome of the erythema, pruritus and pruritus aggravated were not recovered/not resolved.  It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX and triamcinolone acetonide. It was unknown if the reporter considered the pruritus aggravated to be related to triamcinolone acetonide. Additional details were provided as follows: On 9th October 2018, the patient saw his dermatologist and was prescribed a triamcinolone ointment. On 10th October 2018, in the morning, the patient applied the ointment then later that day he received SHINGRIX. Next morning, the patient experienced redness and itching all over his chest, stomach, back and arms. Some time later the patient saw his dermatologist again for a previously scheduled appointment and he was this time prescribed triamcinolone cream to treat the itching he was experiencing. Less than a month after using the triamcinolone cream the really broke out and the itching was continuous. The patient received Benedryl to get some sleep. The patient's dermatologist thought that the itching was caused by SHINGRIX. The patient's pharmacist thought it might be caused by the triamcinolone. The patient had stopped taking both triamcinolone formulations, but still had the itching. The patient was going to a quick clinic on the reporting date to see a doctor. The physician details were provided.
I received the second shot on Thursday 2:30 pm. At 3:00 AM on Sunday, July 25, my heart started beating irregularly. My heart rate was extremely unstable and was fluctuating erratically from 60 to 130; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported for himself that a 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0181), via an unspecified route of administration, administered in Arm Left on 22Jul2021 14:45 (Age at vaccination 50 years) as dose 2, single for covid-19 immunisation. Patient had no medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : EW0181), via an unknown route of administration on 01Jul2021 in left arm at 02:45PM (Age at vaccination 50 years) as dose 1, single for covid-19 immunisation. On 25Jul2021 at 3:00 am on sunday, the patient stated that heart started beating irregularly. heart rate was extremely unstable and was fluctuating erratically from 60 to 130 for around 5 hours. Patient received no treatment for event. The patient underwent lab tests and procedures which included heart rate: 60 to 130 bpm on 25Jul2021 heart started beating irregularly. No prolonged hospitalization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug Store. Patient was not received any other medications within 2 weeks of vaccination. The clinical outcome of event was recovered on unspecified date in Jul2021.  No follow-up attempts are possible. No further information is expected.
Arm red; Arm swollen; Hurt arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and PAIN IN EXTREMITY (Hurt arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure and Diabetic.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and PAIN IN EXTREMITY (Hurt arm). At the time of the report, ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and PAIN IN EXTREMITY (Hurt arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
24 hours post injection (4/25/03) Hepatitis A and Typhoid pt developed hives, itching on face and neck and mouth - swollen lymph nodes neck. Pt had yellow fever vax 4/17/03.
shingles; This case was reported by a consumer via media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The reporter know the patient. The age at vaccination was not reported. The patient got shingles right after getting the shingles shot. The follow-up could not be possible as no contact details were available.
Aug2021 started to feel numbness on bottom of feet. By Oct2021 numbness encompassed feet and ankle.; Sural nerve damage; Idiopathic Peripheral Neuropathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 22Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing). Concomitant medication(s) included: NABUMETONE. The following information was reported: HYPOAESTHESIA (disability) with onset 21Aug2021, outcome "not recovered", described as "Aug2021 started to feel numbness on bottom of feet. By Oct2021 numbness encompassed feet and ankle."; NEUROPATHY PERIPHERAL (disability, medically significant) with onset 21Aug2021, outcome "not recovered", described as "Idiopathic Peripheral Neuropathy"; NERVE INJURY (disability) with onset 21Aug2021, outcome "not recovered", described as "Sural nerve damage". The events "aug2021 started to feel numbness on bottom of feet. by oct2021 numbness encompassed feet and ankle.", "sural nerve damage" and "idiopathic peripheral neuropathy" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) negative, notes: Results of all testing was negative for injury or disease; Electromyogram: (unspecified date) Sural nerve damage; Magnetic resonance imaging: (unspecified date) negative, notes: Results of all testing was negative for injury or disease; SARS-CoV-2 test: (14Sep2022) Negative, notes: Other. Therapeutic measures were taken as a result of hypoaesthesia, nerve injury, neuropathy peripheral.
since receiving the shot all his allergy symptoms have went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1,single and administration date 18Mar2021 (Lot number: 6198) as dose 2,single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 19Mar2021, outcome "unknown", described as "since receiving the shot all his allergy symptoms have went away".  Additional information: Patient who has taken the second COVID vaccine shot, and since receiving the shot all his allergy symptoms have gone away. The transfer agent states that the patient currently has several respiratory issues right now and has immune system challenges. The transfer agent states that the patient did take the two vaccines with no symptoms. Caller confirmed information provided by transfer agent as correct. Caller states that his regular ongoing symptoms have been reduced by 99 percent. His runny/stuffed up nose, itchy eyes, asthma, all was reduced to 0 after taking the two vaccines. Caller states that he wants to be in a Pfizer 3rd shot trial. Caller confirms that after receiving the vaccine that his symptoms went away. He states that he lives in (privacy) and it has a very large (privacy) community and he is significantly afraid of getting the variant. He states that the virus is already in (privacy). Caller states that's how the original virus started in (privacy). He states that a man went to a conference in (privacy) and then went back to (privacy) and they determined that he and everyone around him were carrying the virus. Caller states that he does not want to get the virus because he has had friends that died from the virus in April of last year. He states that he is interested in any possibility of a Pfizer 3 trial. He states that he does take allergy shots every week. He is on maintenance which means they don't increase the dose any further, which means he sufferers all week. He states Pfizer which is a great company should have a way of checking mRNA of people who have allergies and that may be the way to go. Caller states that he got better. He was taking Tylenol 3000 mg a day for sinus headaches. He states that his Tylenol usage has dropped almost to zero.  He says that every possible symptom of the sinus problem the eye itching, nose, throat problems, and nose have almost disintegrated. He states its almost amazing.   No follow-up attempts are possible. No further information is expected.
pt reports vaccine was put in lt side of heart & had surgery on genitals;MD witnessed this on 25JAN99;Annual follow-up received on 11/14/00 provides no additional data.  Follow-up: 4/2/99 admitted t Hosp. by coroner. Just awarded disability. Vaccine injected into heart near breast. Hx of sz. Pt seems to think that his mother and doctors were conspiring together to kill him. He thinks that his mother took the insurance money from his injuries and spent it on herself. He said he almost died several times and that he only received $3,000.00 and that he needs to be compensated for his injuries. He said when the good Lord takes him that he wants this to stop, because parents conspire to kill their kids for insurance money and the children either come out retarded or die from being vaccinated. (1) I'm requesting for new information such as copies of reports. (2) And do I O a hospital bills.
Presented with generalized weakness, nausea, and vomiting x 2 days; COVID-19+; tx w/abx, steroids, zinc, melatonin; did not require O2. dc home.
Information was received from a campus safety officer and an office manager concerning a male patient who, on  an unspecified date, was vaccinated with a dose of PPV.  On approximately 07 MAR 2005 the patient "broke out with a reaction" who was "not diagnosed".  Unspecified medical attention was sought.  At the time of this report, the patient had not recovered.  The office manager was requesting compensation for the PPV.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the center for biologics evaluation and research and was released.  Additional information is not expected.