chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; MILD POST VACCINATION REACTIONS; This spontaneous report received from a patient concerned a 46 year old white and not Hispanic/Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 to left deltoid as prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the patient had mild reaction post vaccine but was fine (got this after probing). On 02-APR-2021, the patient had Covid symptoms like a cold with runny nose. On 13-APR-2021 the patient took a Covid test and got positive test result on 14-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild post vaccination reactions, had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210432529-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
During the course of 2 weeks following the injection my arm, shoulder, shoulder joint and radiating up my neck and down my biceps was unbearable. Given pain meds, no help.
DIARRHEA, BODY ACHES, SEVERE SORENESS IN ARM THAT INJECTION WAS GIVEN.
Rt arm pain after tetanus shot. Arm and elbow sore. No fever. Slight swelling. Tender lateral deltoid, tricep and brachioradials. No warmth. Hurts at night. No chills.
knee replacement; Hidradenitis suppurativa flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4436002-00.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "knee replacement"; HIDRADENITIS (medically significant), outcome "unknown", described as "Hidradenitis suppurativa flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "knee replacement" and "hidradenitis suppurativa flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Walking difficulty; Back pain; Rash; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), BACK PAIN (Back pain) and RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain in arm). On 16-Mar-2021, the patient experienced RASH (Rash). On 23-Mar-2021, the patient experienced GAIT DISTURBANCE (Walking difficulty) and BACK PAIN (Back pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), GAIT DISTURBANCE (Walking difficulty), BACK PAIN (Back pain) and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment. Treatment for the symptoms included Benadryl and Hydrocortisone. The patient received the first dose of the Moderna covid 19 vaccine on March 13th and reported that the next day the arm was just sore, the next day to that one it had a little rash, and the following next day a rash on the whole length of the arm. The patient said that on March 23th had pain on the arm and then in the back to the hips, started having a lot of pressure on the back, and with the right leg hard time walking. The caller didn't clarified when but had chemotherapy.
On 1.8.21, woke up with a temp of 101.8 oral, chills, body aches, terrible headache
pt recvd vax 12JUL95 & 18JUL95 pt broke out;@ the time of report on 20JUL95 pt had 13 to 15 lesions;No further details were provided;
Rash on forearms; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and RASH (Rash on forearms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Rash as a chil), Contrast media allergy (Delayed while body rash), Osteoporosis and Osteopenia. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and CALCIUM for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). On an unknown date, the patient experienced RASH (Rash on forearms). At the time of the report, RASH ERYTHEMATOUS (Red rash) and RASH (Rash on forearms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  Patient took second dose on 19- Feb-2021 in left arm.   This case was linked to US-MODERNATX, INC.-MOD-2021-065221 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up updated on 28-Jun-2021, added patient demographics, relevant medical history, concomitant product details, new event-Rash on forearm.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065221:Dose 2
I have had COVID-19 twice since being vaccinated. My mother has had the same vaccine as me and we have both gotten COVID. I have experienced headaches, body aches and fatigue.
Started out with a rash behind my knees in early morning.  Quickly moved to groin area, behind and on ears, back of head/neck, hip area, under/around breast & underarm area.  Intense itching.  Saw clinic nurse practitioner at an Urgent Care facility around 6:30pm that night.  She gave a steroid injection and Prednisone for me to take for next 5 days.
Swelling of right thigh (entire); erythema to medial portion, warm to  touch.
Extreme chills, low grade fever, nausea, very lethargic, horrible headache - symptoms lasted 2.5 days
pt devel a fever preceded by a gen tonic-clonic sz;had temp of 40.5 in ER & had a febrile sz lasting about 2min;pt put on CR monitor & watched for any sz;
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were probably received doses of improperly stored PNEUMOVAX 23 (lot # M006141; expiry date: 28-MAY-2017) (incorrect product storage) The vaccine was stored at a temperature of -13.6 degrees C for 48 hours. There was no previous temperature excursion. Data logger was involved. No adverse effect reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
The patient developed hives within 15 minutes of receiving the vaccine. The patient was 1st treated wtih Benadryl cream or pills. After 2 weeks and they still kept appearing, the patient was treated with methylprednisolone tablets.
Within 12 hours extreme flu like symptoms; Shooting pain down the leg; Nausea; Vomiting; Serious fatigue; Maybe chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Within 12 hours extreme flu like symptoms), PAIN (Shooting pain down the leg), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Serious fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included ESTRADIOL and LEVOTHYROXINE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Within 12 hours extreme flu like symptoms), PAIN (Shooting pain down the leg), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Serious fatigue) and CHILLS (Maybe chills). In April 2021, INFLUENZA LIKE ILLNESS (Within 12 hours extreme flu like symptoms), PAIN (Shooting pain down the leg), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Serious fatigue) and CHILLS (Maybe chills) had resolved.      Concomitant medications includes over the counter allergic pills as needed.  No treatment medications provided.   This case was linked to MOD-2021-378207, MOD-2021-378216 (Patient Link).
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown  date the patient was vaccinated with ZOSTAVAX (lot number, expiry date, route and site not reported). On an unknown date the patient experienced disseminated zoster. The outcome of disseminated zoster was unknown at reporting time. The reporter considered disseminated zoster to be related to ZOSTAVAX. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Heart was racing became very tired, hard to breathe. Blood in stool. Rash on face left cheek, chin. Sore throat, slept a lot, chest pain.
Nausea and throwing up, headache, stabbing stomach pain and as of today weak and red lump at injection site.
Information has been received from a licensed practical nurse referring to an unspecified patient of unknown demographics. On 07-DEC-2015, the patients were vaccinated with improperly stored ROTATEQ (lot # M029252, expiry: 14-MAR-2018) for prophylaxis (dose and route unspecified) which were exposed to temperatures outside of the recommended range. No adverse effects have been reported. There was no product quality complaint involved. No additional information was provided. The outcome of incorrect product storage was unknown.  Temperature: 72 F Time frame: 1.5 Hours Was it administered (AE)? Yes Was previous temperature excursion? No Was call because of a "data logger"? Yes Additional information has been requested.
Fever up to 101 degrees F, left arm swollen at the area of vaccination-on Saturday 05/17/2003, Monday 05/19/2003 area only slightly swollen afebrile-98.5 degree F.
Shot in left arm - pain from shoulder to elbow - some tingling in fingers, take TYLENOL for the pain - helps for a couple of hours. Still have pain in arm.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Terrible pain; between my belly and vagina on my pelvic floor has been bruised; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "lump of inflammation under skin on low back for unknown causes (appeared after being exposed to Covid but did not test positive)" (unspecified if ongoing), notes: lump of inflammation under skin on low back for unknown causes (exposed to Covid test Negative). Concomitant medication(s) included: LETROZOLE; NORETHISTERONE; HYDROXYZINE. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19,, Previous dose brand: Pfizer,, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose number: 1), for Covid-19 Immunization; Bnt162b2 (Previous dose details, Previous dose product: COVID 19,, Previous dose brand: Pfizer,, Previous dose brand unknown: False,, Previous dose lot unknown: True,, Previous dose number: 2,), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 22Apr2022, outcome "not recovered", described as "Terrible pain"; CONTUSION (non-serious) with onset 22Apr2022, outcome "not recovered", described as "between my belly and vagina on my pelvic floor has been bruised". The events "terrible pain" and "between my belly and vagina on my pelvic floor has been bruised" required physician office visit.  Additional Information: Patient was in Terrible pain starting the day after for a week. Then, the space in between my belly and vagina on my pelvic floor has been bruised since a week after my booster.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Fever, cellulitis left arm, reddened, swollen area. Treatment: Keflex 250/5 lt. p.o. TIDx7 days.
Left shoulder bursitis Narrative: 36 yo male with PMH GERD, hx of positive covid test on 6/4/2020, and dyslipidemia reported having L shoulder pain with limited range of motion following Moderna Covid19 vaccine on 2/1/2021 at an urgent care visit. Patient received the vaccine on 1/18/2021. At that time, vaccine was administered w/o complications. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. Per patient, the injection went well but he developed pretty significant shoulder discomfort with the first 24 hours. Pain improved with a few doses of OTC NSAIDS. However, per patient, it has gotten worse over the past week with limited ROM. Patient was diagnosed with left shoulder bursitis Moderna covid19 vaccine, likely due to where the injection site was (higher up than normal) per PCP. Pt was prescribed naproxen 500 mg BID for 7 to 10 days, referred to PT and f/u with PCP in 5-6 weeks to see if MRI is needed.
Dizziness (1 day), nausea (3) days, sore arm (2days), sore shoulder blade ( 2 days), loss of appetite (2-3 days), low grade fever 24hrs, dehydrated ( 3-4 days)
swelled up everywhere that I had any injury; teeth have been pulled; gums all swelled up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12May2021 (Lot number: El00177) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stroke" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc; "brain bleed" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc; "arthritis" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc; "severe ruined disc" (unspecified if ongoing), notes: Other medical history: Stroke, brain bleed, arthritis and severe ruined disc. The patient's concomitant medications were not reported. Past drug history included: Remeron, reaction(s): "allergy", notes: Known allergies: Remeron, clonidine, doxycycline; Clonidine, reaction(s): "allergy", notes: Known allergies: Remeron, clonidine, doxycycline; Doxycycline, reaction(s): "allergy", notes: Known allergies: Remeron, clonidine, doxycycline. The following information was reported: SWELLING (non-serious) with onset 20May2021, outcome "not recovered", described as "swelled up everywhere that I had any injury"; TOOTH EXTRACTION (non-serious) with onset 20May2021, outcome "not recovered", described as "teeth have been pulled"; GINGIVAL SWELLING (non-serious) with onset 20May2021, outcome "not recovered", described as "gums all swelled up"; CEREBRAL HAEMORRHAGE (non-serious), outcome "recovered", described as "I have a brain bleed". The events "swelled up everywhere that i had any injury", "teeth have been pulled" and "gums all swelled up" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of swelling, tooth extraction, gingival swelling which included pain medicine.  Additional information: She did not receive any other vaccines in four weeks. Her reaction was that she had swelled up everywhere that she had any injury. her teeth have been pulled and her gums all swelled up. Prior to vaccination, she was not diagnosed with covid-19. She was not tested positive post vaccination.  Follow-up attempts are completed. No further information is expected.
Papular/pustular rash developed on right arm, on 12/7 spread to left arm with development of arthralgias both knees and shoulders, on 12/8 rash spread to both legs and became pruritic in all areas, on 12/9 went to physician's office where blood work revealed acute renal failure {Cr 4.3}, sent to ER for admission. Admitted 12/9 - 12/14; readmitted 12/15 with altered mental status, discharge home 12/24.
This spontaneous report as received from a 64 years old female consumer with COMPAZINE allergy and no other pertinent medical history refers to herself. The patient was vaccinated with a dose of ZOSTAVAX on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-AUG-2012, a few hours after vaccination, the patient experienced headache and injection site soreness. The patient had been taking TYLENOL. But it was not relieving her headache. The patient had not sought any medical attention. No lab diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information is not expected.
Pt. states that after receiving the 1st dose of Phizer 08/19/2021, started experiencing symptoms 08/25/2021 of a raised bump in the genital area and irritation. Urgent Care (08/28/2021) visit diagnosed with Bacterial Vaginosis, 2nd Urgent Care visit diagnosed with UTI. Treated with (2 rounds) Antibiotics and Anti-Viral. Still continuing to experience symptoms.
Patient had chest pain, abnormal EKG and was admitted to the hospital with a diagnosis of pericarditis
No adverse events listed - tested positive for COVID-19 on 4/21/21 04/21/21 0445  COVID-19 (SARS CoV-2,RNA Molecular Amplification)  Collected: 04/20/21 1126 | Final result | Specimen: Swab from Nares   COVID-19 SARS-CoV-2 Overall Result DetectedCritical
A dry patch of skin developed on the left side of face approximately 30 minutes after vaccine dose 1 was received. On 3/20/21 at approximately 07:30 AM EST, the patient removed the band-aid from the injection area. The band-aid easily came off...and so did some of her skin with it. Intermittent burning sensation (minor) throughout body, especially on the left side, lasting at least 3 days after injection. No treatment performed to date.
On 8/31/22 pt received first doses of Tdap, Menactra and HPV. Received call from Pt's mother today 9/2/22 she  called to report yesterday 9/1/22  pt's arm was red and swollen at injection site in muscle area of left arm. She gave pt benadryl and ibuproen, the redness and warmth swelling   was the size of quarter/ golf ball size, now  today 9/2/22 redness and warmth is size of soft ball on left arm. Mom stated pt does not have any fever, and no nausea or vomiting. Instructed mother to take pt to her primary care Dr for eval today. She stated dr.'s office does not have any appts open today. She will take her to urgent care today for evaluation.
Diagnosed with COVID-19; minor symptoms of Slight fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID-19) and PYREXIA (minor symptoms of Slight fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced COVID-19 (Diagnosed with COVID-19) and PYREXIA (minor symptoms of Slight fever). At the time of the report, COVID-19 (Diagnosed with COVID-19) and PYREXIA (minor symptoms of Slight fever) 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.   No concomitant medication and and treatment information was provided.
Starting on 13DEC2022 I had sinus issues for a couple of weeks and I went to the Doctors on 15DEC2022 with sinus pressure congestion a low fever slightly winded and was treated with antibiotics which helped and then on 04JAN2023 I had congestion and cough but went to the Doctors on 04JAN2023 with fever congestion sore throat and was treated with an antibiotic and a nasal spray Antrovent after that I had a hysterectomy on 10JAN2023 .  On 27FEB2023 I went to the Doctors again with a severe cough and was treated with cough medicine.  03FEB2023 I had   a shingles vaccine and had a fever a few days from that.  Starting 24April2023 through today I have had ongoing sinus issues that I am treating with OTC medication.