chrisvoncsefalvay/vaers-outcomes huggingface dataset:
recovered from all except she still has the cold symptoms and muscle/ joint pains.; Chills; Tired; Muscle and leg aches and pains; developed a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (developed a cold), ARTHRALGIA (recovered from all except she still has the cold symptoms and muscle/ joint pains.), CHILLS (Chills), FATIGUE (Tired) and MYALGIA (Muscle and leg aches and pains) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced NASOPHARYNGITIS (developed a cold), CHILLS (Chills), FATIGUE (Tired) and MYALGIA (Muscle and leg aches and pains). On 29-Apr-2021, the patient experienced ARTHRALGIA (recovered from all except she still has the cold symptoms and muscle/ joint pains.). At the time of the report, NASOPHARYNGITIS (developed a cold), ARTHRALGIA (recovered from all except she still has the cold symptoms and muscle/ joint pains.), CHILLS (Chills), FATIGUE (Tired) and MYALGIA (Muscle and leg aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Mother states pt had a fever last evening of 105.0 rectally. Pt rec'd his #4 DTaP, #3 Comvax 1/8/03 at approx. 1100. Fever today is 103.3 rectally. Mother states she's giving pt Tylenol q 4hrs. Inst. to call PMD for further inst.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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, pain and suffering, and other damages. Additional information has been requested.
p/vax pt rt eyelid became painful to touch;pain migrated to forehead, then down lt side of face, down the lt side of body to lt leg, then to rt leg up as far as abd on rt side;
Patient had a shingles rash from the injection site up to the back of his neck. This occurred the day after the vaccination was administered.
tiny Blood Blisters from her ankle to below her knee on the outside of both legs; Swelling; Itching; Sick to her stomach; red strip about 2 inches wide on both sides of her legs; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (tiny Blood Blisters from her ankle to below her knee on the outside of both legs), SWELLING (Swelling), PRURITUS (Itching), ABDOMINAL DISCOMFORT (Sick to her stomach) and ERYTHEMA (red strip about 2 inches wide on both sides of her legs) in a 77-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia (Irregular heart beat), Gastroesophageal reflux disease, Fibromyalgia, Arthritis, Back pain, Neck pain, Hypoxemia (Oxygen level drops at night.) and Neuropathy (Issues with nerves). Concurrent medical conditions included Chronic idiopathic urticaria and Blood pressure high. Concomitant products included OMALIZUMAB (XOLAIR), HYDROXYZINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), BENAZEPRIL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE (PROPANOLOL HYDROCHLORIDE), DIGOXIN, PANTOPRAZOLE SODIUM, CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN AND CODEINE), GABAPENTIN, SERTRALINE and OXYGEN for an unknown indication.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced BLOOD BLISTER (tiny Blood Blisters from her ankle to below her knee on the outside of both legs), SWELLING (Swelling), PRURITUS (Itching), ABDOMINAL DISCOMFORT (Sick to her stomach), ERYTHEMA (red strip about 2 inches wide on both sides of her legs) and NAUSEA (Nauseated). On 27-May-2021, SWELLING (Swelling), PRURITUS (Itching) and NAUSEA (Nauseated) had resolved. At the time of the report, BLOOD BLISTER (tiny Blood Blisters from her ankle to below her knee on the outside of both legs) and ERYTHEMA (red strip about 2 inches wide on both sides of her legs) had resolved and ABDOMINAL DISCOMFORT (Sick to her stomach) outcome was unknown.            Patient took steroids as treatment.
C/o nausea at 7pm on 10/25/10 that progressed to vomiting at 3am (10/26), accompanied by chills & higher temp of 99.1. Denied inj site local reaction no red no swollen no weakness at arm, denied diarrhea.
Hot flash; Heart rate increased; Dizzy; Nauseated; Stomach pain; throat felt hoarse; Dry throat; Rash/hives left side of face and arm,entirety of chest; Rash/hives left side of face and arm,entirety of chest; Tightening of chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 08Mar2021 at 10.30 (age at vaccination was 39-year-old), as single dose of COVID-19 immunisation. Medical history was not reported. Patient was allergic to sulfa medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), and Daily Vitamin (MANUFACTURER UNKNOWN) for unknown indication. On 8Mar2021 at 10.30, patient experienced hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measure was taken as a result of events hot and cold flash, heart rate increased rapidly, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest, Rash/hives and treatment included IV antihistamine (50mg Benadryl injection) Pepcid. The clinical outcome of the events hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest was recovered with lasting effects. Information about lot/batch number cannot be obtained. No further information is expected.
I experienced mild flu-like symptoms the next day. In February 2022 I developed an itchy, bumpy rash on the back of my head. It spread over the next few weeks to my neck and shoulder, around my waist and on both elbows. I saw my PCP in March and she prescribed steroidal cream for the itch. She increased the strength of the topical twice in the next 2 months and then referred me to a dermatologist. I saw him in July 2022 and he told me it was a reaction to the booster. He prescribed another topical, Clobetasol Propionate Foam .05%, which helped with the itch, but not the rash. He then gave me a 30-day sample of Cibinqo 100mg to take once a day and prescribed Loratadine 10mg to take twice a day. The Cibinqo has been effective, but the cost is prohibitive at $5,000 a month for 30 pills. The next option is Dupixent at $3,300 per month, also out of the question. I have tried taking the Cibinqo once every other day, but the rash returned with 2 -3 days. At this time, I have not been offered an affordable treatment option and I do not know what the resolution will be. Pfizer apparently caused this issue and now they want to charge me $60,000 a year to treat it.
This is an initial spontaneous report by a non contactable consumer. This female consumer reported on behalf of a male patient who was administered with first dose of PREVNAR 13 (Lot # E88939) unknown dose unknown frequency on his thigh for an unknown indication on 17Jan2011. Relevant medical history was unknown. Relevant concomitant medications were unknown. This office staff mentioned that he was administered with second dose on 17Mar2011, third dose was administered on 16May2011 and fourth dose was administered in 2011. Vaccines given on the same day included ROTATEQ, DAPTACEL and HIB. Vaccines taken within the last four weeks were none. In 2011 while on PREVNAR 13 unknown dose unknown frequency he was infected with pneumonia with stereotype 16F. Relevant lab data was unknown. At the time of the report it was unknown if he was still on PREVNAR 13. At the time of the report clinical outcome of above mentioned event was unknown.
A report has been received from a Pharmacist concerning a 43 year old, male subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started during Aug-2013. The patient experienced severe headache. At the time of reporting, the event of severe headache was ongoing. The report was considered to be non-serious.
I had fever, chills, fatigues, and nausea, I passed out the same night, so the next day I went to the doctor and she stated everything was fine.
extreme tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8279) via an unspecified route of administration in the arm left on 12Apr2021 at 13:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic asthma, hypertension, arthritis and tinnitus. 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. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and famotidine (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received omeprazole sodium (MANUFACTURER UNKNOWN), midazolam (MANUFACTURER UNKNOWN), ketamine (MANUFACTURER UNKNOWN) and amoxicillin/clavulanic acid (MANUFACTURER UNKNOWN) and experienced drug allergy. On 15Apr2021 at 13:15, the patient experienced extreme tinnitus since vaccination, previously patient had a history of tinnitus that had been tolerable, but after vaccination it was extreme. 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 event extreme tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle). On 18-Mar-2021, INCORRECT DOSE ADMINISTERED (Received approximately 0.62ml of vaccine) and DEVICE CONNECTION ISSUE (About half of the vaccine spilled out because of an error in the needle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.; Reporter's Comments: This report refers to a case of incorrect dose administered, and device connection issue for mRNA-1273, lot # 040A21A with no associated AEs.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter work in a doctor's office and he wanted to report an adverse event with the patient who had a small red area at the site of injection. No fever or other issues were reported.
Flushing, throat tightness, slight headache. Treated with Diphenhydramine 12.5mg IV x 1, Famotidine 20mg IV x 1, and Methylprednisolone 125mg IV x 1.
vaccine administered subcutaneously rather than intramuscularly. patient complains of pain at site for approximately 20 minutes following injection.
Pt reported feeling hot and flushed and was itching.  No swelling/tingling reported in throat/mouth, or difficulty breathing.  Pt vitals: HR 102, O2sat:96%, BP:160/110.  Patient's itching spread and she began shaking.  50mg IM benadryl was given in R arm.  Vitals monitored and were as follows: 5:45pm: BP:140/90, HR:86, R:18, spO2:96% - Patient reported improvement in itching and redness 6:15pm: BP:138/85, HR:78, spO2:98% - Significant improvement in itching, redness and shaking. Patient reported feeling much better and that vitals were normal.  Patient released.  Educated to take oral benadryl and call 911 if difficulty breathing or severe reaction. Pt and husband acknowledged understanding.
Case number PHEH2015US020944, is an initial spontaneous report received from a medical assistant on 14 Oct 2015. This report refers to a 3 year old male patient. Medical history and concomitant medication was not reported. The patient received the FLUVIRIN (batch number: 15733P) intramuscular in error. No adverse event was reported following the maladministration.
brain bleed after 1st COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6200, Expiration Date: 30Jun2021) at the age of 81 years intramuscular for covid-19 immunisation; apixaban (ELIQUIS), for anticoagulant therapy. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: CEREBRAL HAEMORRHAGE (hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "brain bleed after 1st COVID-19 Vaccine". The event "brain bleed after 1st covid-19 vaccine" required emergency room visit. The action taken for apixaban was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026448 Same patient, same product, different dose, different event;US-PFIZER INC-202300026488 Same patient, same product, different dose, different event;
This spontaneous report as received from a medical assistant refers to two patients of unknown age. The patients were vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) in August 2011. The medical assistant reported that the patients came back on 06-NOV-2012 and received their second dose of GARDASIL (lot #, dose and route not reported). The medical assistant was wondering if the patients would have to start the series over. No other co-suspects were reported. No concomitant medications were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Patient presented the next day to the clinic with swelling, redness, rash, and pain in the left arm.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA006448: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575.
Shingles; Her reaction was very painful; Groggy; Didn't feel right; rash on her leg; itchy; Fatigue; Cold sores lip; This is a spontaneous report from a contactable consumer (patient, respiratory therapist). A 29-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in right deltoid on 04Jan2021 (Lot number EL1284 or ELI284) as dose 1, single at the age of 29-year-old for COVID-19 immunization. Medical history included eczema diagnosed maybe 6-7 years old, chicken pox, COVID-19 in Oct2020. There were no concomitant medications. The patient experienced shingles on 06Feb2021, fatigue in Jan2021, cold sores lip in Jan2021, groggy, didn't feel right in Jan2021, rash on her leg in Jan2021, itchy in Jan2021, her reaction was very painful. In Feb2021, caller was diagnosed with shingles that leads to several emergency room and hospital visits. From then on, she did not proceed in getting her 2nd dose following the AE she experienced. The seriousness of shingles was hospitalized and medically signficant. Within 1.5 weeks after the COVID-19 Vaccine, she started getting fatigued, got a cold sore, and then a rash on her leg. Rash was first itchy, then turned into sore and painful. The rash began spreading. She went to the ER. Was then diagnosed with shingles and got on an antiviral and it went away. Clarified she felt fatigued within the first week of the COVID-19 Vaccine. She didn't feel right. Had COVID-19 virus two to three months before that. She felt groggy and started developing a cold sore on her lip. Then noticed the rash on her leg. Then found out it was shingles because it was extremely painful. Had a lot of adverse reactions. Never attempted to get the second dose. Had to take a medication post visiting the Emergency Room on 06Feb2021. Clarified medication as Valacyclovir. She didn't respond well to the COVID-19 vaccine. Didn't take second dose. Works in the medical field. Has done the testing and is following protocol. Didn't want to get the second shot because she had to take the antiviral medication after the first dose. It was really bad. Has a form that needs to be filled out by an RN, Nurse Practitioner or a doctor that exempts her from receiving the second shot. Her reaction was very painful. Fatigue has improved drastically after she had the antiviral, but it took a while, at least 3-4 weeks before it went away. Had to cover up rash and patch it. Her body was shocked from the response. She has recovered. But is having more frequent cold sores that are still occurring. Shingles was on her right thigh. She has scars now. Had COVID-19 Virus in Oct2020. Diagnosed with shingles 06Feb2021. Put on Valacyclovir. It took a while, three to four weeks for it to go away. Unable to query NDC/LOT/EXP. Treatment received for shingles, fatigue. The outcome of shingles, rash on her leg was recovered in 2021. The outcome of fatigue was recovering. The outcome of cold sores lip was not recovered. The outcome of other events was unknown.
Started with pain around breast area and as it dissipated the pain went into the lower back. May and June the pain got worse to where walking or sitting was unbearable. He had 2 Lumbar Spine X-rays on or about July 16, 2021 which showed lesions on spine.  On 8/4/2021 he had an MRI done which showed Metastatic Squamous Cell Carcinoma. From that point on I watched the tumors appear on his body and head. He  died 9/7/2021.
Severe pain in left shoulder. Unable to rotate shoulder or lift arm due to severe pain. Shoulder cramping with limited range of motion. Pain is currently persisting x 2 weeks. I am scheduled to see a doctor.
Healthy 2 mo old, rec'd routine Pediarix, Prevnar and HIB. >3 hrs extreme fussiness, crying, resolved by 12-24 hrs.