chrisvoncsefalvay/vaers-outcomes huggingface dataset:
constant pain that radiates to her neck on left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (constant pain that radiates to her neck on left side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011l20a) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included METFORMIN and NADOLOL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (constant pain that radiates to her neck on left side). The patient was treated with THERAWORX RELIEF for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (constant pain that radiates to her neck on left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow Up received contains No new information.
Night sweats  Lymph node swelling & painful  Body aches, sore muscles  Extreme fatigue  Foggy brain / mixing words up/ birthday confusion  Dizzy Nausea  headache  Stuffy nose  Tongue pain  Tingling hands /cold  Elbow - tendinitis?   Dry mouth  Late period Lost milk supply (breastfeeding)  10 days post vaccine: Dizzy  Headache Dry mouth Nausea  Tired  Brain fog  Lymph node swelling  Overall yucky feeling Night sweats  Low grade Fevers nightly (continued for more than 3 months)
Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) 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.   Concomitant product use was not provided by the reporter.   No treatment information was provided.  Patient exhibited no symptoms and no treatment was given by the time of this call.
sore arm,headache, fever, nauseous   bed rest, ibuprofen 36 hour recovery from onset of symptoms
Sudden irreversible hearing loss right ear. Did not improve after prednisone oral and two injections through the eardrum.
Vesicular rash - starting on 11/25 or 26th. Developed cellulitis on arm after scratching.
Within a few minutes, I felt mildly dizzy, but it went away after about 5 minutes. By 8pm, I had severe arm pain that got worse throughout the night so I could barely sleep. Headache started around 5am the next morning. By 8am, the fatigue set in and my headache got progressively worse. By 11am, I the nausea set in. I almost vomited multiple times. By 12pm, my headache was now a migraine. I was very fatigued, nausea, and had bad chills. I felt like I was freezing! The chills subsided within a couple hours and never returned. I had nausea on and off for 2 days and a nonstop headache for about 4-5 days. My arms was extremely sore and I didn?t start to feel any real relief for about 3 days. The soreness lasted about 5 days. On day 5, I noticed a large, grapefruit size, rash appear around the injection site
Breakthrough case admission after 3 vaccines Moderna 7/26/21 Lot# 006C21A;  Moderna 9/18/21 Lot# 005C21A;  Pfizer 12/22/21 Lot# 330130BA
long term side effects from Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (long term side effects from Moderna) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (long term side effects from Moderna) (seriousness criterion hospitalization). At the time of the report, IMMUNISATION REACTION (long term side effects from Moderna) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. The patient never tested positive or diagnosed COVID. No Concomitant medications were reported. No treatment medications were reported.  Company comment- This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. A caller inquired on behalf of her husband inquiring what is needed to report long term side effects from vaccination with mRNA-1273, including hospitalization and emergency room visits. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected, serious (hospitalization) event of Immunisation reaction which occurred at an unknown time with regards to the mRNA-1273 vaccination. A caller inquired on behalf of her husband inquiring what is needed to report long term side effects from vaccination with mRNA-1273, including hospitalization and emergency room visits. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received the his 2nd RotaTeq vaccine on 6/30/10.  He awoke on 7/6/10 with vomiting bile, then became lethargic; taken to pediatrician's office at 2:45 PM on 7/6/10, and then sent directly to Emergency Department by Dr.; patient was then flown by STAT helicopter to another hospital, where he underwent emergency surgery on 7/7/10 for open repair of intussusception; patient was discharged from hospital today, 7/9/10.
Received Hepatitis A and Varicella on 8-11-11. On 8-12-11 at 6:36 patient seen at Urgent Care with complaint of swelling on Rt arm at injection site - Temp 97.8 F. Rx for KEFLEX and BENADRYL given.
Swollen lymph node under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient 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 15Apr2021 at 00:00 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history included duchenne muscular dystrophy (reported as duchenne). The patient had known allergy to mango. The patient previously took sulfamethoxazole (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN) for unknown indications and experienced drug allergy. 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 COVID vaccine. Concomitant medications included pregabalin (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN) and amitriptyline (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates and unknown if ongoing. On 21Apr2021 at 16:00, the patient experienced swollen lymph node under left armpit. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen lymph node under left armpit was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
welt like rash under one of her breast and a round red circle on top of one another.; Itching by her chest; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date, after vaccination, within 4 hours later when she went to bed, she was itching by her chest. She looked in the mirror and had a welt like rash under one of her breast and a round red circle on top of another one. She does not know if it is from the vaccine or not. She had no other symptoms, and it was gone the next morning when she woke up. Outcome of the events were resolved on an unspecified date.  Follow-up attempts completed. No further information expected.
redness, swelling rt deltoid x 48hr;c/o stiff neck, h/a;(5x5cm area of erythema & warm to touch, & tender);paraspinal tenderness, cervical region;
This spontaneous report as received from a pharmacist via a company representative refers to an approximately 74 year old female patient allergic to penicillin. On an unknown date the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously.The patient who, after receiving ZOSTAVAX, developed a raised knot at the injection site, that looked like a bug bite. The pharmacist did not indicate the color of the knot, but was specific that it was not a rash. The time frame between injection and reaction was unknown, but field representative stated that it was not an immediate reaction to the injection. Field representative also mentioned that decades ago, the patient had a similar reaction to an unspecified penicillin shot (Manufacturer unknown). Patient medical attention by going back to the pharmacy. The outcome of raised knot at the injection site was reported as recovered/resolved. Additional information has been requested.
Itchy rash 3 days later on his torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rash 3 days later on his torso) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash 3 days later on his torso). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash 3 days later on his torso) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported. Patient took cortizone cream 1%.
The patient was to receive his second Pfizer Covid dose but was accidentally administered a flu shot. He had already received his flu shot for the year so this was his second dose. He got his first flu shot on 9/7/21. When the patient was followed up with the next day he had no adverse reactions at that time. It's unknown if he had any later on.
Information has been received from a pharmacist concerning a 78 year old female with high blood pressure who on 19-NOV-2006 was vaccinated IM with a 0.5 mL second dose of Pneumovax 23 (Lot# 655289/0958F), one to two years after her first dose. Concomitant vaccination on 19-NOV-2006 included a dose of influenza virus vaccine (unspecified). Other concomitant therapy included 2 unknown high blood pressure medications. On 21-NOV-2006 the patient was listless, tired, and had a headache. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
No additional AE or PQC reported; Caller stated the PEDVAX HIB was administered after a temperature excursion; This spontaneous report has been received from an unspecified reporter and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions, drug allergies, reactions and concomitant therapies were not reported.  On 15-MAR-2022, the patient was vaccinated with an improperly stored dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at a dose of 0.5 ml, lot number T030711, expiration date: 15-APR-2023 (vaccination scheme frequency, anatomical location, and route of administration were not provided).  The administered dose of the vaccine experienced temperature excursions on 23-FEB-2022: 48.4 Fahrenheit degree (F) for 2 hours 25 minutes, on 03-MAR-2022: 49.3F for 2 hours 50 minutes, on 08-MAR-2022: 46F for 30 minutes and on 09-MAR-2022: 47.8 for 3 hours 56 minutes. No additional adverse event was reported.
Diffuse head and facial swelling and urticaria. Admit to hosp for 3 days given epinephrine, Solumedrol and Benadryl
Fever, chills, aches, pains, stomach cramping, fatigue  The chills, aches, and stomach cramping were the worst of it. Side effects lasted for 48 hours
Pt vaccinated with Pneumovax 23 developed pneumococcal bronchopneumonia.
Took one dose of Vivotif and then forgot to take it for 5-6 days; A spontaneous report was received from a pharmacist on 24JUN2022. It described a patient (unknown age and gender) who "took one dose of Vivotif and then forgot to take it for 5-6 days" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took one dose of Vivotif and then forgot to take it for next 5 to 6 days.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient took one dose of Vivotif and then forgot to take it for 5-6 days (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took one dose of Vivotif and then forgot to take it for 5-6 days (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Patient called stating he woke with a fever 100.7.  Will call and report if no better
HCP reported administering GARDASIL 9 to a pregnant patient.; No additional AE; This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided. On unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated due date (EDD) was not known. The pregnancy outcome was unknown.   On an unknown date the pregnant patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose number, route and site of administration, lot# and expiration date were not provided) (exposure during pregnancy and no adverse event).
I developed sores on my tongue and in my mouth; I developed sores on my tongue and in my mouth; Swollen and painful glands; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin (PCN), mycins and sulfa. 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 COVID vaccine. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 01Apr2021 at 08:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 06May2021, two weeks after the second dose, the patient developed with sores on her tongue and in her mouth, along with swollen and painful glands. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sores on her tongue and in her mouth, along with swollen and painful glands were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache, nausea, fever, dizzy, body aches, chills  Next day - crossed vision, couldn't walk straight - went to urgent care, sent to ER
Information has been received from a registered nurse concerning a patient who on approximately 21-JUL-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot# 659342/1517U) (route and administration site not reported). The patient did not receive other vaccines that day. Within hours of the shot the patient experienced an injection site reaction and swelling at the injection site. The swelling worsened the day after the vaccination. Additional information has been requested. This is one of several reports from the same source.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date in August 2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, expiry date in July 2016 (dose, route of administration, anatomical location and lot # were not specified). This is one of two reports received from the same reporter. Additional information has been requested.
Back of hands, back of next and back covered in hives and chills within 4 hours of receiving  the vaccine. The chills I brushed off as I get cold easily to begin with, but this has been ongoing throughout the night now.
No additional AEs; GARDASIL 9 administered to patient following excursion; This spontaneous report was received from a Physician and refers to a patient of unspecified gender and age.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  The reporter informed about a temperature excursion for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # W006559 has been verified to be a valid lot number, expiration date: 04-DEC-2024), as follows: Temperature 32.7F; time frame 48 hours; previous temperature excursion 33.8F for 5 hours 30 minutes.   On 24-APR-2023, the patient was administered a dose of this hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # and expiration date as reported, administered for prophylaxis (dose and route of administration were not provided), following the excursion (Product storage error). There were no additional adverse events (AEs) reported (No adverse event); no product quality complaints (PQCs) were reported.
Blistering rash; Rash on left arm; Fever; Left arm pain & swelling; Left arm pain & swelling; Frequent loose stools; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH VESICULAR (Blistering rash) and RASH (Rash on left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Insomnia since 28-May-2014 and Hyperlipidemia on 15-May-2014. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) from 28-Feb-2014 to an unknown date and ALPRAZOLAM from 15-May-2015 to an unknown date for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH (Rash on left arm) and PYREXIA (Fever). On 06-Apr-2021, the patient experienced RASH VESICULAR (Blistering rash). At the time of the report, PAIN IN EXTREMITY (Left arm pain & swelling), PERIPHERAL SWELLING (Left arm pain & swelling), DIARRHOEA (Frequent loose stools), RASH VESICULAR (Blistering rash), RASH (Rash on left arm) and PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On 6-apr-2021 patient contacted office as her rash started blistering and was advised to see the dermatologist The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No treatment product information was provided   This case was linked to MOD-2021-044643 (Patient Link).
Patient presents local reactions with swelling and redness in his upper arms. For treatment BENADRYL and Ice.
10/15 Left arm red swollen hot to touch, 10/16 numbness and tingling feet, 10/17 numbness and tingling up to shins, 10/18 numbness and tingling up to thighs painful ambulation.
I experienced injection site pain in the left upper arm which seemed intense.  I woke up at 0100 with severe body aches, cold sweats and shivering.  It was hard to walk the body aches were horrible.  I checked my temp and it was 100.3 F
RASH OVER ARMS AND LEGS. STARTED 6 DAYS AFTER VACCINE.
pt in SNF; positive for COVID after hip surgery; per death certificate, pt died in the SNF of MI, atherosclerotic heart disease, hypercoagulable state, and COVID 19