chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possible COVID infection between doses; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Possible COVID infection between doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COVID-19 (Possible COVID infection between doses). At the time of the report, COVID-19 (Possible COVID infection between doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided. Reporter asking if second vaccine is needed if subject had Covid  Company comment: This spontaneous case concerns a patient, unknown age and gender, with no reported medical history, who experienced the non-serious unexpected event of Possible Covid-infection on unknown date after the unspecified dose of mRNA 1273 vaccine. Subject was asking if a second dose of vaccine is needed if he had Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, unknown age and gender, with no reported medical history, who experienced the non-serious unexpected event of Possible Covid-infection on unknown date after the unspecified dose of mRNA 1273 vaccine. Subject was asking if a second dose of vaccine is needed if he had Covid.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Patient states on 10/17/19-10/19/19 he had abdominal pain and aches which abated on 10/20/19.  Then he had constipation but was able to have a bowel movement on 10/21/19.  Later on 10/21/19 he was seen in the ER with a complete bowel obstruction.  He states he is still having issues with abdominal pain and is going to have an upper and lower endoscopy on 11/26/19.  Dr. wanted to wait until then due to patient still having inflammation of his bowels. He was prescribed famotidine 40 mg every night and augmentin 875/125 mg twice a day for 5 days on 10/25/19; then on 10/28/19 he was prescribed pantoprazole 40 mg every morning; on 11/5/19 he was prescribed a suprep bowel kit; on 11/13 he was prescribed VSL #3 probiotics.
right, upper lip twitching immediately following injection, still occurring off and on diarrhea around 8 hours after injection some fatigue
Later in the night had soreness to right arm. Woke up next am 02/18/2003, symptoms increased-red line down arm, pain up into right side neck. Pt called on 02/19/2003 to report the symptoms. Still with red line down right arm, redness, pain, knot to injection site. States has generalized aches to body. Advised pt to see M.D. or go to ER. Pt said will do so.
Muscle cramps on the outer side of his right lower leg; A spontaneous report was received from a consumer concerning a 71-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle cramps on the outer side of his right lower leg/muscle spasms.  The patient's medical history mentions radiation therapy for prostate cancer and anterior fusion of the neck in 2003. Concomitant medications were not provided.  On 10 Feb 2021, approximately 22 days prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, post the first dose of the vaccine, the patient experienced muscle cramps on the outer side of his right lower leg between the knee and the ankle. This would occur when he puts pressure on his right butt cheek. The cramps had become worse to the point that he cannot walk.  On 10 Mar 2021, the patient received the second of the two planned doses of mRNA-1273 (Batch number: 001B21A) in the right arm for prophylaxis of COVID-19 infection.   The event, experienced muscle cramps on the outer side of his right lower leg, was deemed a disability due to mention of not being able to walk.  Treatment information mentioned baclofen and applied foam patches and a hot and cold compress. Lab tests were not provided.  Action taken with mRNA-1273 in response to the events was not applicable as patient took both doses of the vaccine.  The outcome of the events, muscle cramps on the outer side of his right lower leg, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Joint pain started after first 24 hours across entire body.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 16:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 15:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 after the first 24 hours (also reported at 15:30), the patient experienced joint pain across the entire body. It had since subsided everywhere, but constant, persistent pain continued in both the knees, whereas previously, there was no joint pain. The patient had no history of joint pain. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain across entire body and persistent pain continued in both the knees was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a health care worker refers to a female patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H013581; Exp date 03-MAR-2014) (dose and route not reported) a "couple of weeks ago" (approximately in 2012). No other co-suspects were reported. No concomitant medications were reported. The health care worker reported that the patient developed cellulitis, high fever and chills after receiving a dose of PNEUMOVAX 23. The patient was admitted into a hospital (unknown name and location) for 24 hours. The outcome of cellulitis, high fever and chills after receiving a dose of PNEUMOVAX 23 was reported as recovered on an unspecified date (in 2012). The relatedness for the reported events was not provided for PNEUMOVAX 23. Additional information has been requested.
Visual defitict: floaters and blurry vision, headaches, swollen lymph nodes, involuntary tremors, numbness and tingling, progressively worse since his 2nd Moderna vaccine on March 29, 2021  Unable to see neurologist, earliest appointment 30 days out.
Pt was given a Pfizer booster diluted with children Pfizer instead of normal saline. Was given approximately x2 dose. Reporting error to VAERS in case there are future side effects.
AFTER GIVING ZOSTAVAX (SHINGLE VACCINE) SHE WAS HAVING ITCHING AND SHE TOOK BENADRYL TABLET. AFTER THAT ITCHING WAS GONE AND NEXT DAY SHE WENT TO PRIMARY CARE DOCTOR. AND HE TOLD THE SAME THAT SHE IS ALLERGIC TO THAT DRUG. NOW PATIENT IS FINE AND WE UPDATE THE PATIENT PROFILE WITH ALLERGIC TO ZOSTAVAX.
I felt like my whole body was one big bruise; If I touched my skin, it felt like it was on fire; I literally could not move without aches everywhere; I couldn't bend my elbows cause the pain was excruciating; severe headache; exhaustion; muscle pain that was horrible; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating) and HEADACHE (severe headache) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for Ache NOS. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included PARACETAMOL (TYLENOL) for Pain, OXYCODONE for an unknown indication.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 24-Oct-2023, the patient experienced CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating), HEADACHE (severe headache), FATIGUE (exhaustion) and MYALGIA (muscle pain that was horrible). At the time of the report, CONTUSION (I felt like my whole body was one big bruise), BURNING SENSATION (If I touched my skin, it felt like it was on fire), MOVEMENT DISORDER (I literally could not move without aches everywhere), JOINT CONTRACTURE (I couldn't bend my elbows cause the pain was excruciating), HEADACHE (severe headache), FATIGUE (exhaustion) and MYALGIA (muscle pain that was horrible) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available.  No treatment medications were provided.
Flu like symptoms; Low grade fever; body aches; chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:15 (lot number and expiry date: unknown) at the age of 48-years-old, as dose 2, single for Covid-19 immunisation. Medical history included shellfish allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 at 09:15 AM, at the age of 48-years-old, in the right arm, for Covid-19 immunisation. The vaccine was administered in a hospital. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 16Feb2021, at 01:30 AM, the patient experienced flu like symptoms, low grade fever, body aches, chills, and fatigue. The patient did not receive treatment for the events. Outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021233905 similar report from same reporter
Vial of vaccine reconstituted improperly and administered on 07/08/2021. Patient's mother notified on 07/09/2021 and home visit was conducted on 07/10/2021 to re-vaccinate with appropriate dose of 0.3ml.
guillain-barré syndrome Paralysis of left had Chronic debilitating chest pain inability to function on daily basis
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical center/hospital (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUL-2016, the patient was treated (by an unspecified health care professional) at the medical center/hospital for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Mother reports that evening she put the child to bed and later noted on her video baby monitor it appeared the child was "gasping for air". She picked her up and her breathing returned to normal. She laid the child back down and shortly after it began again. This time she noticed wheezing so she took the child to the ER where they gave her "steroid" breathing treatments and monitored her overnight. Told her the child may have asthma. No further episodes. The child did not have any rash, hives, fever, or obvious lip/tongue swelling.
pt presented to emergency dept 1hr p/vax;pt exp hives lt side of face & swelling in throat;no local redness or rash on rt arm
Severe itching of both calves at all hours of the day but flared up the most at night. After a couple of weeks, the itching spread to both thighs (on the front and back) while also continuing on both calves. No topical treatment (including  0.1% Triamcinolone Acetonide Cream) or oral treatment (including Benadryl) alleviated the itching. The itching continued upon receipt of my second Moderna dose  on October 20, 2021 and continued for approximately four weeks, finally resolving around Thanksgiving 2021. There have been no flare-ups to date. There was no discoloration or swelling of the skin; just an intense itch.  Additionally, my menstrual cycle has been impacted as I now get my period every 14-21 days as opposed to my regular cycle of 28-30 days. This has been the case since receiving my first Moderna vaccine on September 22, 2021.
Systemic: Chills-Mild, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Severe, Systemic: Vomiting-Mild, Systemic: Weakness-Severe, Additional Details: shot 4:23pm, pt complained of seeing stars, being nausous, weak, was going in and out of concsiousness for 30 -45 seconds. Had patient elevate legs a while seated and took bp at 4:30pm was115/36 pulse 52. pt tried to vomit but nothing came up.Took 2nd bp at 4:44pm 137/91 pulse 75. Moved patient inside pharmacy had her lay down flat with legs elevated for 8 minutes. complained of tingliness in both arms up to elbows. 3rd bp at 4:50pm was 127/80 pulse 65, 4th bp 125/82 pulse 77, left at 5pm
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 01May2021, stop date: 04Sep2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccine and medications in two weeks. Paxlovid was given as treatment for COVID-19 from 05Sep2023 to 08Sep2023 .Patient did not have any known allergies.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Vaccinated with BioNTech, with doses 4 weeks apart, and then a third time with Moderna 8; After all doses: slight dent in the injection site; This is a spontaneous report from a Non-contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose and received second dose via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient also received third dose of covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), via intramuscular route from Jun2021 (Batch/Lot number was not reported), as single dose for COVID-19 immunisation. Medical history included hypochondriac and thrombosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient states that he was vaccinated two times with BioNTech, with doses 4 weeks apart, and then a third time with Moderna, 8 weeks later. The patient is now being offered a fourth dose 6 weeks after. The patient states they (the vaccination centres) don't know that he has previously been vaccinated. After all doses on an unknown date in 2021, patient had slight dent in the injection site. The event was considered as non-serious. Patient reports hearing discussions in the media about getting a third vaccination to boost the vaccination. The patient would make the effort to receive the fourth vaccination if advised to do so. The patient heard that the antibody count could be increased by 5 or 10 times if a third dose is received. The patient has also just read that BioNTech is more efficient with a larger time between doses. The patient says they want to be vaccinated again because they are a bit of a hypochondriac and have a medical history of a risk of thrombosis and want to avoid even having a slight case of Covid. The patient has the following questions: Are there studies for receiving multiple doses of vaccines? Is it worth it to receive the fourth vaccination dose from Moderna? Would It make sense to test the antibody numbers let this decide whether a fourth vaccination is necessary? It would be interesting to see the antibody levels in a young person that has been vaccinated so many times. When the patient was directed to contact their HCP, they stated that they were trying to avoid this as they knew their HCP would not be happy with them being vaccinated so many times. The outcome of the event slight dent in the injection site was recovered after 2-3 days on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Developed shingles - Vesicolor contivent 2-3 cm on Red base no surrounding erythema nontender no itch Distal Lat thigh and R lat buttock L3 distal bottom.
This spontaneous case, initially received from other non-health professional on 01-Nov-2018, concerns 64-year-old, adult, female patient. The patient was allergic to Monosodium glutamate (MSG), tetracycline sulfa, and dimerol. The patient did not take any medications at the time of vaccination. On 29-Oct-2018, the patient (of age less than 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250807 and expiry date: 30-JUN-2019] (explicitly coded as inappropriate age at vaccine administration). On 30-Oct-2018, 10 hours after the injection, the patient got up at about 3:30am to wash her hands and she fainted. The patient fell in her bathroom and hit the back of her head (reported as: on something either the wall or something). The patient got up from the floor and she immediately fainted again. The patient stated she was nauseated, and she threw up liquids. The patient had a slight headache, but the headache was not that bad. A registered nurse (RN) stated that the patient could have concussion, but the patient checked with a doctor. A RN was the one who alerted the patient to the possibility of a concussion and that the nausea and vomiting could be due to the fall rather than the vaccine. The patient had a chiropractic spinal adjustment. On 31-Oct-2018, the patient had recovered from the events. The outcome of the event- inappropriate age at vaccine administration was unknown. The reporter assessed the case as non-serious.
Vaccination failure; acute HAV infection;   This literature marketed report was received from authors of a published article, titled as above.  It refers to a 29 year old male patient. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient completed a 2-dose series vaccination with hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. After 3 years, the patient was diagnosed the human immunodeficiency virus (HIV) infection. After 7 years, the patient experienced acute hepatitis A virus (HAV) infection. Previous vaccination for hepatitis did not reliably provide protection among some persons with HIV infection (Vaccination failure). The patient did not received postexposure prophylaxis. The outcome of vaccination failure and hepatitis A was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of the several reports received from the same literature (link reports # 1905USA005761, 1905USA005762).; Sender's Comments:  US-009507513-1905USA005761: US-009507513-1905USA005762:
Tachycardia with symptoms of lightheadedness, shortness of breath, presyncope. Started 11 days after second dose of vaccine. Tachycardia is occurring daily now and appears to be associated with standing/walking and better/normal when sitting/laying.  Also new itching/hives on face, neck, and chest that began 4/1/2021. Lasts 1-2 days and happens once a week or so.
After 30 minutes, she left with her friend who also had recieved the vaccine.  Her friend later noted that her left eye lid had some slight swelling.  She had no hives, no shortness of breath, no other complaints.
10th day p/vax fever 103.2 R, on augmentin for purulent chronic rhinitis, tonsils 2+ enlarged w/small white follicles;pinpoint discrete red rash on trunk;24SEP96 t105 R, v;inc lymph nodes rt inguinal area;given med;25SEP96 t99, bloody
Patient stated. she got Moderna vaccine on 4/30 on Sunday got a rash on her back, the back of her knees, legs and arms that are itchy.  She stated she also has headache. RN asked her if they were hives and she stated yes they are.