chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCH; SWELLING AROUND THE RASH.; Chest tightness; rash; chills; cough; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash), CHILLS (chills), PRURITUS (ITCH), COUGH (cough) and SWELLING (SWELLING AROUND THE RASH.) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 07-Jan-2021 to 21-Jan-2021. Concurrent medical conditions included Allergy to antibiotic, Ragweed allergy, Drug allergy, Diabetes in 2006, Venous ulcer NOS in 2018, Blood pressure high in 1998 and Venous insufficiency (Venous insufficiency both feet) in 2019. Concomitant products included VITAMIN B12 NOS for Anemia, ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, ATENOLOL and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) for Blood pressure management, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30) for Diabetes, VITAMIN D NOS and FERROUS FUMARATE, VITAMINS NOS (ONE A DAY PLUS IRON) for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills) and COUGH (cough). On 05-Mar-2021, the patient experienced RASH (rash). On an unknown date, the patient experienced PRURITUS (ITCH), SWELLING (SWELLING AROUND THE RASH.) and CHEST DISCOMFORT (Chest tightness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 04-Mar-2021 to 14-Mar-2021 for Adverse event, at a dose of 25 milligram once a day and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) (topical) from 04-Mar-2021 to 14-Mar-2021 for Adverse event, at a dose of .1%. On 12-Mar-2021, CHEST DISCOMFORT (Chest tightness) had resolved. On 14-Mar-2021, RASH (rash), CHILLS (chills) and COUGH (cough) had resolved. At the time of the report, PRURITUS (ITCH) and SWELLING (SWELLING AROUND THE RASH.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received 30-Jun-21:  Added relevant medical history, updated concomitant medications, added treatment medications, added date recovered.
Rt. arm immediate pain with shot, still feel where it was given. 5 wks P.T. arm is not what it was before shot. Pain is like nerve pain. Cannot sleep Rt. side.
Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, lot# and route unknown). Concomitant therapy was not reported. On an unknown date the patient fainted after receiving the GARDASIL. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Was doing fine for about 20 minutes while in observation. Then fell out of his chair, was confused, body went stiff, and didn't feel well.
Thrombocytopenic purpura; bruises, petechiae, increased tiredness, still ongoing. Admitted to the hospital, so far she has received 2 doses of Winrho, weekly CBC, platelet count has not recovered, currently ongoing. Per doc 212154, annual follow up, patient seems to be over any adverse event, but her pediatrician has said that she is already prepared to write a letter, because she will not administer the 2nd dose of MMR at age 4.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer link case US2021AMR266342). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles vaccine and got sick but all that been said, he/she did not regret it one bit. The patient stated did not want Shingles if he/she could prevent. The follow-up would not be possible as no contact details were available.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266342:Different dose.
High fever, severe chills, severe cough, runny nose, severe body aches, dizziness, lightheadedness, headache, night sweats, insomnia, sinus congestion.
Lingering pain on ULE, on shoulder/site of injection, radiating down the arm and affecting mostly the upper arm and hand. pain 3/10 constant, at times intensity at 5-6/10.
About a day after immunizations, patient developed an area of red induration, which by day 3 was approximately 3" round area of induration.
The primary reporter is nurse. Nurse reports a second dose of ZOSTAVAX was inadvertently administered to client. Client got the first dose of ZOSTAVAX on 12/07/2011 and the second dose of ZOSTAVAX was administered today. No adverse effects reported at this time. No other information provided.
On the evening of 12/11/2022 I had a low grade fever a felt achy and sore with runny nose and cough. I visited my healthcare provider I started taking ibuprofen, acetaminophen every four hours with cough drops. I quarantined and felt normal on 12/15/2022, I did not feel weak or lethargic and symptom of chest congestion, runny nose has rebounded. I am maintaining a course of some OTC decongestants.
received 1st dose in 8/23/2021 / second dose  was administered 9/10/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2SP, expiry date 14th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd August 2018).   On 10th September 2021, the patient received the 2nd dose of Shingrix. On 10th September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Right thigh ache.  Cannot walk up stairs.  Severe pain to walk up stairs.  There is no strength in the right thigh to lift me to the next step.
Rash on inner thighs and inner arms  (still there on 1/1/21
Took my 9 year old, daughter to pharmacy on Friday 12/06/2019 at 4:55 p.m. to get her annual flu shot.  At 5:17 p.m. I received a phone call from the pharmacist who explained that she accidently gave my daughter the Shingrix vaccination by mistake and was told that this shot was not intended for children and was designed for adults 50 year and older. We immediately called poison control where staff explained to us the possible side effects and to monitor her for the next 48 hours to make sure she doesn't have any major outbreaks or major fever spikes.    Friday evening patient ran a fever most of the evening which we were able to keep her comfortable w/ childrens ibuprofen.  She could barely lift her arm and the injection point on her left arm could not be touched without severe pain.  Arm was swollen at the point of injection and was very red.  Saturday, patient continued to run a fever and slept most of the day which was not like her at all.  She experienced the same level of pain in the arm and functionality was limited.  We again comforted her w/ childrens ibuprofen.  Swelling in the arm had gone down but had splotches of red around the point of injection about the size of the palm of her hand. Sunday evening, patient's fever began to calm down and she started to gain more mobility in her arm with less pain to the touch.  We monitored the red splotches to ensure they remained localized which they did. Monday morning, no fever and she has started to gain what appears to be full functionality in her arm.  Arm still a little red and splotches have not spread as of today.
Body aches for 2 days following second shot, couldn't get out of bed, headache.
erythematous, warm to touch, swollen left arm from IPV-subq vaccination. x3 days ice, Benadryl prn -Local reaction no fever. 1cm nodule, 5cm swelling.
Pt was called 8-4-08 about lab results and told me that the day after receiving VARIVAX injection 8-2-08 her (R) upper arm was swollen. Site better on 8-4-08.
This case was reported by a healthcare professional and described the occurrence of muscle atrophy in a 12 year old female subject who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject's medical history included chronic headaches and penicillin allergy. There were no concurrent medications. The subject had no adverse events following receipt of prior immunizations. On 04 October 2006 the subject received 2nd dose of Havrix in the left arm (720 EU). On 05 October 2006, 1 day after vaccination with Havrix, the subject experienced muscle atrophy at the injection site. At the time of initial reporting, 27 November 2006, the event was ongoing. Comment: Muscle atrophy was assessed as medically serious (OMIC) by the manufacturer.
A mother reported that her son received Rota Shield and subsequently vomited 2 or 3 times in 1 day. He also had "really weird looking stool". The infant recovered without treatment. Follow-up information received from the physician on 10/4/99 indicated that the infant remained recovered.
Approximately 2 months after my 4th dose vaccination I contracted COVID-19 and experienced the following symptoms: Head congestion, Body aches, Sore throat. I took Excedrin, Oregano pills and Magnesium with Vitamin C for treatment but it did not help with my symptoms. I consulted with my Doctor and was prescribed with Paxlovid and Promethazine for 5 days and as of today 07/6/22 it has been my 2nd day of taking these medications. So far, I have seen a little bit of improvement with my symptoms  but I am still congested and very fatigued.
FELL ILL; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; DIED; This spontaneous report received from a consumer via a company representative via social media (JNJ News) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was perfectly healthy and was kept on a proper diet. The patient was previously received 2 doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin and batch number were not reported, expiry: UNKNOWN) dose was not reported, start therapy dates were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first two doses of covid-19 vaccine (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after third vaccination patient fell ill and in AUG-2022, the patient died from unknown cause of death (Dose number in series 2). It was unknown whether autopsy was performed or not. It was reported as "Agreed, A good friend of mine was perfectly healthy, kept to a proper diet, had three vaccines and advised me to stay away from the unvaccinated. However, after the third vaccination, he fell ill and died in August" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on AUG-2022, and the outcome of fell ill and revaccination with different covid-19 vaccine was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221003368.; Sender's Comments: V0: 20221003166-COVID-19 VACCINE AD26.COV2.S- Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
She is allergic to flu shot; This case was reported by a consumer via other manufacturer and described the occurrence of allergy in a 59-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Concurrent medical conditions included cancer (patient had Laryngeal voice box cancer), chronic obstructive pulmonary disease and drug allergy (allergic to mycins, cillins, naproxen sodium, penicillin and erythromycin).   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu shot and had allergy. No other information was provided.
This spontaneous report as received from a physician's assistant refers to a female patient of unknown age. On 27-JUL-2011 the patient was vaccinated with GARDASIL dose 1, on 19-SEP-2012 with dose 2. It was reported that on 22-NOV-2013, the patient would receive the third dose of GARDASIL vaccination series. No adverse effects were reported. Additional information has been requested.
(L) upper arm 4cm x 2 cm raised tender area from Varivax.
Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2011, the patient was vaccinated with ZOSTAVAX, (strength, route, anatomical location, dose, frequency, dose number, lot number and expiration date were not reported), for the permanent prevention and protection against shingles and zoster-related conditions/injuries (prophylaxis). No other suspect or concomitant therapies were reported. On an unknown date, the patient was diagnosed with shingles (herpes zoster) and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure), and suffered serious physical, emotional, and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life (Quality of life decreased); increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions (condition aggravated), lost wages, loss of earning capacity and other losses and damages. On an unknown date in 2012, the patient was treated for shingles. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter determined adverse events as medically significant, disabling and life-threatening events.
Started spotting one week after the first dose of the vaccine.; This is a spontaneous report from a contactable consumer. A 18-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 27Mar2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID -19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies to medications, food or other products. Concomitant medications included ethinylestradiol, norgestrel (CRYSELLE) and birth control; all from an unknown date for unknown indication. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 05Apr2021, the patient experienced spotting menstrual one week after the first dose of the vaccine. The patient menstrual cycle had changed. The patient was on birth control and had never spotted while using pill. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of spotting menstrual was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extreme headache, extreme fatigue, blinding headache.  Had COVID back in Nov 2020 and it truly felt like I had full blown COVID again.
Severe bloating of abdominal, bladder, prostate. Extreme difficulty urinating. 104 fever for 3 days.
Patient got 0.1 ml of TWINRIX administered Intradermally in left forearm. Area became reddened & burned, but by the next day it was gone. On 3/30/11 pt. states area started itching again & reddened. Pt. seen 3/31/11, area red with slight induration measuring approx. 9-11 mm. Iced area, BENADRYL PO & BENADRYL cream PRN.
Patient developed pain/tenderness to the injected area 8 hrs after the vaccination.  The following day developed redness, swelling & nausea symptoms symptoms have resolved.
Right arm and my under armpit are swollen; I am not feeling myself; It is happening in my right arm again and its really painful and its actual going down under like into my breast area and I can't even wear my bra properly; Lymph node and everything was sore; I am feeling sick; I want to throw up. Also, I am not feeling like talking; It is happening in my right arm again and its really painful and its actual going down under like into my breast area and I can't even wear my bra properly; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 49-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150; Expiration Date: 03Apr2021), via an unspecified route of administration, administered in Arm on an unspecified date (Age at vaccination: 49-years-old) as dose 2, single for covid-19 immunization. Medical history included Blood pressure from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included fist dose of BNT162B2 on 10Mar2021 for Covid-19 immunization and experienced Arm was sore, arm just went down with swelling, Lymph node and everything was sore. It was reported that got her second dose of Pfizer Covid vaccine on Saturday and right now, her right arm and her under armpit are swollen and she was feeling sick like she want to throw up. Also, she not feeling like talking. she just want to know like what is this like she was not feeling herself. read side effects and everything. When she got her first dose, she was fine and just like she got the second dose and by the second day, she started feeling very sick. But from the first dose her arm just went down with swelling and everything and she had to go to see my doctor because her arm and the lymph node and everything was sore and now it is happening in her right arm again and its really painful and its actual going down under like into her breast area and I cannot even wear her bra properly. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
pt recv vax; pt presented w/ more than 20 lesions on body & scalp & dx w/ chicken pox;
high fever/100.1 degrees Fahrenheit/100.8 degrees Fahrenheit/99.8 degrees Fahrenheit; arm swelling; arm was very sore; headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via an unspecified route of administration in left arm on 20Jan2021 15:15 at single dose for COVID-19 vaccination. Medical history included ongoing coeliac disease diagnosed four years ago in 2017, allergic to dairy and corn, COVID in Nov2020. There were no concomitant medications, no other recent vaccinations and had started no new medications. The patient had a reaction with a high fever, a headache, and her arm was very sore after vaccination, that were similar to how she felt when she had COVID in Nov2020. The patient's arm was swollen and sore that evening on 20Jan2021. Her first fever was yesterday morning on 21Jan2021, probably at about 10:00AM or 11:00AM, and at that time it was 100.1 degrees Fahrenheit then later in the afternoon at 02:00PM it was 100.8 degrees Fahrenheit. She took Tylenol, applied cold moist cloth, drank lots of liquid for treatment, and she did sleep. Tylenol was clarified to be generic pain reliever, Acetaminophen 500mg. Acetaminophen 500mg, EXP Apr2021, LOT P114992, UPC: 1191717759. Her temperature improved after taking this medication, and it was 99.8 degrees Fahrenheit before bed. She hadn't taken any Acetaminophen this morning on 22Jan2021, but she took two tablets the first time yesterday on 21Jan2021 and then one tablet right before bed. She didn't go to the doctor for this. The outcome of events was unknown.
Monday, 12/06/21: 9:15 am Headache, required a visit to school nurse, call to mom and Tylenol given by mom at school at 9:30 am. More Tylenol given at home after school at 3:30. Ibuprofen  given at 5:30 pm. Tuesday. 12/07/21 Headache at bedtime, Tylenol given at 8:30pm. Monday 12/13/21 9:00 am Headache at school, required a visit to school nurse, call to mom, and Tylenol given by mom at school 9:10am.
Breakthrough COVID-19 case. Asymptomatic. Hospitalization 7/23/2021-7/26/2021. Death on 7/26/2021. From Vital Records: COD = COVID 19 PNEUMONIA. was in hospice then transported to hospital where he died. Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: DEMENTIA HEART DISEASE. Place of death: HOSPITAL-INPATIENT, ; certified by: PHYSICIAN; occ/ind.