chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy) in a 41-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (Got the two shots of the Moderna vaccine, and afterwards got covid-19/breakthrough infection) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative and positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   It was reported that patient didn't take any medication for COVID-19 Infection.   This case was linked to MOD-2021-253192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information included event and event outcome. Changed qualification of reporter.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. This is a case of lack of effect assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). Further information is expected upon follow-up.
IgG4-related autoimmune pancreatitis; Acute liver injury; This is a literature report.  A 63-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 (Dose 1, single (manufacturer unknown)), for COVID-19 immunisation. The following information was reported: IMMUNE-MEDIATED PANCREATITIS (medically significant), 1 month after the suspect product(s) administration, outcome "unknown", described as "IgG4-related autoimmune pancreatitis"; LIVER INJURY (medically significant), outcome "unknown", described as "Acute liver injury".  Clinical course:Acute liver injury and IgG4-related autoimmune pancreatitis following mRNA-based COVID-19 vaccination.; Sender's Comments: Based on the available information in the case, the causal association between the events immune mediated pancreatitis and acute liver injury  and the suspect drug BNT62B2  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Whole body itchy sensation began 8/6/15 and has progressively worsened. Pt advised to begin 10 mg cetirizine QD by Rph tonight.
8FEB97 lt upper arm red, swollen, hot to touch, no fever, no pain-pt is active;itching of area;saw MD-felt it was allergic rxn to vax;no orders given;18FEB97 several messages were left on answering machine no response;unable to contact
So I received the vaccine on my left arm on January 20th and the next day I had swelling on my left arm and neck. It went away within an hour or so. However, on the 28th of January, I woke up with supraclavicular lymphadenopathy on my left side of my neck. So, I have swelling and lumps/growths above my left collar bone. My left arm is numb and tingly and I feel very sick. I am nauseous and have body aches. I went to urgent care and they believe it is a reaction to the vaccine. I was tested for mono and strep throat and do not have either. I took a rapid covid test on Wednesday the 27th and it was negative.
Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease and Thyroid disorder. Concomitant products included ZONISAMIDE for Parkinson's disease, THYROID HORMONES for Thyroid disorder.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with GABAPENTIN for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            Action taken with mRNA 1273 in response to event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: As per the follow up document, the patient has authorized physician for further contact
On 3/12/99 the pt experienced stomach problems and diarrhea. It was reported that the pt had these symptoms after both doses of Hep B, and the pt's mother was concerned about the pt receiving a third dose. The pt's diarrhea persisted. Additional information has been requested.
High blood pressure (190/100 when highest); Tachycardia; Headache; Fatigue; Brief Fainting; Weakness.
10 minutes post vax, the pt fainted; responded shortly after and went back to class. Mom states pt broke out in hives from head to toe. He was given Benadryl.
PATIENT WAS SUPPOSED TO HAVE RECEIVED A SECOND DOSE OF JANSSEN; HOWEVER, RECEIVED PFIZER.
Information has been received from a health professional concerning a 72 year old male who on 05-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 08-NOV-2007 the patient experienced hives on neck, back and scalp 3 or four days after receiving the vaccination.  Per the nurse, "the patient looks like he got chicken pox".  Unknown if the patient recovered.  No product quality complaint.  Additional information has been requested. Follow-up information received from the physician indicating Information has been received from a physician via a medical record concerning a 72 year old male who on 05-NOV-2007 was vaccinated with ZOSTAVAX (lot# 658082/0744U) via the right upper arm. Concomitant therapy included BENADRYL, DIOVAN, LIPITOR, metoprolol tartrate, ORABASE-B, triamcinolone and triamcinolone acetonide. On approximately 20-NOV-2007 the patient experienced headaches and nausea. On approximately 22-NOV-2007 the patient experineced " the patient looks like he got chicken pox" and hives on neck, back and scalp. It was reported that the patient was a 72-year-old gentleman who is referred in for evaluation of possible varicella. The patient recalls no history of chickenpos or shingles, and on 11/5/2007 received the ZOSTAVAX vaccine. Fifteen days later, he reports headaches and nausea. and then 17 days after the original vaccine a rash erupted. He describes it as being on the neck with water blisters and then spreading to all parts of the body, healing with hemorrhagic crusts. He denies current symptomatology including fevers, chills, sweats, headach, shortness of breath, or cough. Physical examination revealed multiple erythematous papules and a few pustules on an erythelnatous base, some with hemorrhagic crusts diffusely. Clinical impression was that of varicella secondary to the ZOSTAVAX vaccine. It does appear that varioliform eruptions are well describes in the setting of vaccination, independent of previous immune status. A shave bisosy from the right forearm was obtained to confirm the diagnosis. Results of dermatologist review are as follows: Clinical impressions was Varicella. Diagnosis Epidermal necrosis, ulceration and re-epithelialization. There are no specific cytopathic features of herpes virus infection, although this pattern of ulceration and vascular congestioncould have been produced by a virus. Biopsy of a leasion earlier inits evolution would be diagnostic. Gross view: Specimen was received fixed in formation consisting of tissue measuring 9X6X1 cm, submitted after bisection. Microscopic evaluation as follows: There is evidence of re-epitheliazation and a difuse dermal infiltrate which is heterogenous in composition. There was marked congestion of blood vessels. There is a small focus of abcess formation with degenerated collagen. There are clumpsof subcorneal neutrophils and eveidence of necrosis belistering which was replaced by re-epithelializaiton. Additional information is not expected.
around 5:30pm pt called answering service/on call and reported she started getting itchy & hives all over her body. Lips & tongue felt swollen. Pt felt itchy for 1 hr prior to hives appearing.  On call instructed pt to take 2 benadryl s/sx mostly resolved by AM
Admitted to hospital for left arm cellulitis; treated with Nafcillin and then Clindamycin. Admitted 12/20/05; discharged 12/23/05. Arm was hot, tender, tense from deltoid to elbow on admission to hospital. Added terms from Discharge summary rec'd 01/12/2006: Fever, decreased ROM/sr
According to pt's mother, had "high fever of 104.9" for 4 days.  Unable to "break the fever", took child to ER for evaluation; also "red bumps" on "sites of injection"; fever "broke" after 5 days.
Ongoing reaction, every 3-4 weeks. Gets hives, skin feels like it is burning, eyes swell, throat swells, difficulty breathing,  sensation and hives spread through entire body,  body temp lowers, last about an hour or so every time.
A healthy, active, young, female got Covid at the end of November, then diagnosed with Acute Lymphoblastic Leukemia (B cell, Ph -) on December 19, 2021. Symptoms: bruises, fatigue, heavy period, fever, out of breath, night sweats
Pharmacy administered Moderna Vaccination after the vial was punctured and at room temperature for longer than 12 hours. The vial was punctured on 4/21/2022 @ 08:37 AM, which means the vial expired on 04/21/2022 @ 08:37 PM. The vial was left out overnight and was used for patients' vaccination on 04/22/2022 @ 11:44 AM. Patient has been notified and has had no adverse events related to vaccination.
Excruciating headache; Strong body aches; Strong chills; Hot face; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ew0169) via an unspecified route of administration in the left arm on 22Apr2021 at 17:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Dec2020. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (EUTHYROX) and amlodipine (MANUFACTURER UNKNOWN); both for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ep7533) via an unspecified route of administration in the left arm on 30Mar2021 at 17:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 06:00, the patient woke up with excruciating headache, strong body aches, strong chills and a hot face. The patient stated that no thermometer was available. The events did not result in doctor or other healthcare professional office/clinic visit, 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 events. The clinical outcome of the events excruciating headache, strong body aches, strong chills and hot face was not resolved at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Generalized pruritis, parasthesias or "electrical tingling" in extremities and face. No visible rash.
Experienced radiating pain in (L) chest, (L) arm, (L) neck and (L) upper back. Pain sensation increased upon applying pressure to chest.
Red,raised, warm spot on my arm ,at where i got the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red,raised, warm spot on my arm ,at where i got the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red,raised, warm spot on my arm ,at where i got the shot). At the time of the report, VACCINATION SITE ERYTHEMA (Red,raised, warm spot on my arm ,at where i got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 19-JAN-2016 the patient was administered with a dose of improperly stored M-M-R II (albumin status rHA, lot# L010488 and expiration date 26-MAR-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
?Covid arm?. Upper arm is hard, hot to the touch, big red welt and itchy. Started nine days after the shot.  Has not gone away yet, 36 hours later
2 days after vaccines, she suffered Sudden Cardiac Arrest requiring defibrillation, intubation, and ECMO.
Patient was getting first covid pfizer vaccine after administering patient experienced itching and feeling hot at injection site. After sitting for 10 minutes patient developed a redness and hives chest area and around neck. Advised to stay longer and gave dose of 25mg 10ml of diphenhydramine. Patient sat for another 15 minutes. Looked better advised if gets worse to call emergency or to go to hospital ER.
This spontaneous report was received from a health care worker (medical assistant) regarding unspecified number of patients of unknown gender and age. The reporter states that on an unknown date the patient's were vaccinated with RECOMBIVAX HB (dose, frequency, lot number, expiry date not reported). Also reported that the patient's were administered doses of RECOMBIVAX HB that were improperly stored and no adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Severe...hives, welts, rashes on my lower face, neck  and chest with chapped lips and a COLD SORE on my upper lip which I've never had before. This lasted for over 6/SIX WEEKS. It was a nightmare. I also had the extreme lethargy( tiredness) a day after which lasted for 2 days, aches and terrible dizzy spells in the morning for about 3-4 days.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot # K008814 with expiration date of 19-JUN-2015, therapy type unkown, lot #K024825 with expiration date of 02-DEC-2016, therapy type rHA, dose strength and route unknown). No adverse effects reported. This is one of several reports received from the same reporter (MARRS# 1508USA008214, 1508USA008196, 1508USA008271, 1508USA007973). Additional information has been requested.
This spontaneous report as received from a consumer refers to her husband, a male patient of unknown age. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX. Indication, dose number, lot number, expiry date, anatomical location and route of administration were not reported. On 22-AUG-2013, reported as 1 month after the vaccination date the patient experienced genital herpes. The patient was treated with unspecified medication and recovered from the event of an unknown date. The outcome of genital herpes was reported as recovered/resolved. This case was linked to case 1311USA009500, based on the same reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to an approximately 7 year old male patient with no pertinent medical history and no drug reactions/allergies. On 23-AUG-2007 the patient was vaccinated with the first dose of (Oka/Merck) PROQUAD lot # 656887/0150U, expiration date 11-JUL-2008, 0.5 ml, subcutaneously in left thigh and a second dose of (Oka/Merck) PROQUAD lot reported as "0651Z" (which is an invalid lot # for (Oka/Merck) PROQUAD), 0.5 ml, subcutaneously in the right arm on 25-OCT-2010. No concomitant medications were taken. The result of a varicella titer done on an unspecified date in August 2013 was negative. No treatment was given. On 12-AUG-2014 the patient sought medical attention at the office of nurse for an unspecified reason. The outcome of the event was unknown. Additional information has been requested.
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269128-00 (Agency).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was unknown.  Clinical information: Solicited report by a consumer of an adult female with an event of non-serious COVID-19 with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA (ADALIMUMAB). It was not reported if events did abate after stopping drug or reappear after reintroduction.  The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility and for PFIZER BIONTECH COVID-19. VACCINE(TOZINAMERAN) causality was reported as possible for the event(s) of COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19 cannot be totally excluded.
Muscle weakness in Legs, numbness and tingling. Dizziness, difficulty walking. Numbness and tingling in arms. Neurology referral, MRI's. Still being evaluated.
Patient was vaccinated before the 18th birthday with Moderna vaccine, a medication administration error  parent reported that child had a sore arm following vaccination, but no other adverse effects
Patient received the second dose 1 week before due date; A spontaneous report was received from a nurse concerning a 34 year old, female patient who received Moderna's COVID-19 vaccine and the patient received the second dose 1 week before due date (21 days after first dosage).     The patient's medical history was not provided.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 031K20A) on 14-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection.   The patient received their second dose of mRNA-1273 (Batch number: 042L20A) on 04-Feb-2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient received the second dose 1 week before due date (21 days after first dosage).     Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not unknown.  The outcome for the event Patient received the second dose 1 week before due date was considered resolved on 04-Feb-2021.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 042L20A with no associated AEs.
Patient experienced flushing and headache approximately 15 minutes post-vaccination. Patient's vital signs were WNL. Patient provided analgesic for headache, but declined antihistamine.