chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 28-APR-2009, the physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 06-MAR-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
The expiration date written on the card says 5-9-21; severe cold; stuffed up nose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (severe cold), NASAL CONGESTION (stuffed up nose) and EXPIRED PRODUCT ADMINISTERED (The expiration date written on the card says 5-9-21) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE for an unknown indication.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 17-May-2021, the patient experienced NASOPHARYNGITIS (severe cold) and NASAL CONGESTION (stuffed up nose). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date written on the card says 5-9-21). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at a dose of 1 dosage form. At the time of the report, NASOPHARYNGITIS (severe cold), NASAL CONGESTION (stuffed up nose) and EXPIRED PRODUCT ADMINISTERED (The expiration date written on the card says 5-9-21) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contactable physician. This physician reported for a 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID on 10Jul2020 and 11 weeks of prolonged illness. The patient's concomitant medications were not reported. Patient with no significant risk factors except for a BMI of 34. On day 33 (13Aug2020) post diagnosis she was PCR and IgG positive. On 01Dec2020, patient had the first Pfizer Covid vaccine dose. The first 2-5 days (Dec2020) were described as very bad, fever to 101F, chills, headache, body aches, congestion. The week after she was somewhat better but didn't feel better until day 9 post vaccination. Outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Pt recv vax on 10/21/98; on 10/22/98 pt exp cellulitis (15 x 13 cm), erythema, warmth, pruritus
About 2-5 minutes after giving the vaccine the patient started to convulse in the waiting area while I was administering flu vaccine to her friend.  This lasted for about 10 seconds and she was conscious and not convulsing when I ran to her to ensure her safety and 911 was called. I returned to administer the vaccine to her friend where she began convulsing again and fell to the floor, in which I instructed her to lay on the floor until help arrived.  About 5 minutes later the paramedics arrived and took her and her friend to the hospital.
Swollen red patch on arm at the injection site approximately 1 week following injection.  3-4 day duration.
Arm was sore; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN6201) via an unspecified route of administration, administered in Arm Right on 25Apr2021 11:30 (at the age of 51-years-old) as single dose for covid-19 immunization. Medical history included hypertension from an unspecified date and ongoing. She doesn't know when the blood pressure started, around 2018 to 2019. She had the Afib maybe 2 years ago, so 2019. AFib (atrial fibrillation) from an unknown date in 2019 to an unknown date. She has high blood pressure. She is extremely young to have this, but she had been in the hospital once for Afib which typically happens to people that are older, unhealthy, overweight, and in their 70s or 80s. When she was in the hospital everyone said she didn't belong there. It is rare to be young and have it to the extent she did. She has an underlying condition that is very critical for her. God forbid she catches Covid. The patient's concomitant medications were not reported. It was reported that the patient arm was sore on 26Apr2021. She was expecting her arm to be sore. Everyone said when they got the shot it will feel sore. For her it felt like when she works out too hard and hasn't worked out and is just sore. It was nothing alarming to her. After her first shot she was sore by late afternoon or evening the next day. She had the first dose on 25Apr2021. She had all those tests done recently prior to the Covid shot she would say in December 2020. She had a lot of workups done bloodwork-wise and everything else. The outcome of the event was unknown.  Additional information has been requested.
c/o extreme swelling & hardness to large area surrounding vaccine site;c/o mild wheezing & dyspnea;seen @ urgent care rx pred;
Patient reports 2 days after vaccination, sore arm and tingling in hand on arm that was vaccinated that has continued up to 2 weeks after vaccination. Shot location had a hard knot and discomfort for 2 weeks after. Recommended to use OTC anti-inflammatories and follow up with MD if continued tingling.
very sore arm; soreness spread to my whole body/My pain right at the moment is at a 7; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; Erythromelalgia/Since the shot, this rare condition has not stopped flaring; My blood sugar has stayed over 250 with a top number on the evening of the last shot of 419; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 28Apr2021 18:30 (Batch/Lot Number: EW0171) (at the age of 60 years old) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HBP), ongoing erythromelalgia, overweight. Patient was not pregnant at the time of vaccination. Patient did not have Covid prior to vaccination. No known allergies. The first dose was administered on an unknown date for covid-19 immunisation where patient felt nothing. Concomitant medication included oxycodone taken for erythromelalgia, start and stop date were not reported. After the second dose, on 28Apr2021, her blood sugar has stayed over 250 with a top number on the evening of the last shot of 419. On 29Apr2021 01:00, she developed a very sore arm, unlike the first shot where she felt nothing, her soreness spread to her whole body. Patient would be in more pain than the level 5 she was at but she took Oxycodone 10.05-325 for a rare condition called erythromelalgia. Since the shot, this rare condition has not stopped flaring. Her pain right at the moment was at a 7 (29Apr2021). Therapeutic measures were taken as a result of all the events. Increased insulin. Patient was not tested for Covid after vaccination. Outcome of the events was not recovered.
Fever, body aches, HA and fatigue. Treatment: Tylenol, Outcome: Did not interfere with ADLs
Syncope.  Pt sustained abrasion to right forehead.  BP 140/90 initially, 120/80 when released form recovery area.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. In February 2013, the patient was vaccinated with the first dose of GARDASIL (route and lot # not reported). The nurse reported that second and third doses of GARDASIL were administered too close to one another. The second dose of GARDASIL (route and lot # not reported) was administered on 09-APR-2013 and the third dose of GARDASIL (route and lot # not reported) was administered on 11-JUN-2013. No adverse effect was reported. Additional information has been requested.
5.5cm x 3cm red, raised, tender, indurated @ inject site on rt thigh; responded to warm compresses; no generalized sx noted;
Later that night after the vaccine I developed severe chest pains that lasted about 4 or 5 hours and subsided on it on with no additional symptoms.
Bullous Pemphigoid; condition aggravated; little blisters all over her body; This is a spontaneous report from a contactable consumer (patient)   An 85 years old male patient receivedfirst dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EY0584) on 03Aug2021 at 11:30 at single dose via an unspecified route of administration  for COVID-19 immunization. Patients Medical History (included Thyroid disorder, Bullous Pemphigoid and acid reflux. In 2015 patient had kidney stones and she was taking 8 Advils and 1 Hydrocodone every 8 hours at the advice of physician. She had a drug reaction from that and it caused Bullous Pemphigoid which were blisters, a skin problem (as such). She had this for 6 years. The Bullous Pemphigoid was supposed to be gone after 5 years but she still had. (as reported). She stated about every 5 years she gets the pneumonia vaccine and has never had any problems with it.  Concomitant medications included SYNTHROID (levothyroxine sodium). Patient informed Her last flare of Bullous Pemphigoid was last May/June this year and after she got the 1st dose of the vaccine, she broke out again in a big flare of Bullous Pemphigoid. d. It was nasty. The doctor gave her cortisone cream and wanted to prescribe a Prednisone Pack for 12 days to take before she gets her second Covid 19 vaccine. She was leery to do this. How can she take a chance in getting the second Covid 19 vaccine. She wants to get the second Covid 19 vaccine but doesn't want to get another flare. Patient  went to her doctor regarding her Bullous Pemphigoid flare. He could see her rash and didn't know what to do, no one knows what to do. No one was familiar with this skin disease, it's a very rare autoimmune skin disease. It causes little blisters all over her body. She fortunately had a very mild case so her blisters look like little pimples. She had to put Cortisone, a lot of Cortisone on her legs and thighs and bra line. Patient was also concerning  if there is any information on Pfizer Covid vaccine and Prednisone pack interaction and if there is guidance whether she should receive the 2nd dose given that she had a flare with the Bullous Pemphigoid. At the time of the reporting events outcome was unknown.  Follow-up attempts are completed. No further information is expected
Neck pain, specifically on the right side (Covid injection side), when neck extended up and tilting head down. Feels like a lymph node getting pinched. About 8 on pain scale (to 10) Had to stabilize my neck to prevent that motion.
The flu Vaccine was given on 11/24/2021 and then 2 days later both the Moderna and Shingrix vaccines were given on 11/26/2021.  Following the Moderna and Shingrix vaccinations the pt reports becoming very tired and "walloped" on or about 11/28/2021.  Pt reports that it became and to some extent still is "difficult in having an intelligent conversation with others (and wife)".  He has had difficulties in memory and in tasks out in public such as running a debit card as he forgets the pin.  Pt reports that he has never had such memory problems prior to the vaccinations and was always the one "to remember things and be the sharp one in the room".  The Patient was able to recall jobs and history while on the phone but still states he feels fuzzy or clouded at times.  Pt states he did not report this adverse event and I discovered this during the follow-up call for the second shingrix vaccine the Pt is due.
Blood test abnormal; Fatigue; Inflammation; ache; Flu like symptoms; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue), INFLAMMATION (Inflammation), PAIN (ache) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Plaque psoriasis and PREDNISONE for an unknown indication.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 10 D and PREDNISONE (unknown route) at an unspecified dose. On an unknown date, the patient experienced BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue), INFLAMMATION (Inflammation), PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills). At the time of the report, BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue) and INFLAMMATION (Inflammation) outcome was unknown and PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Fatigue), PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) to be probably related. No further causality assessments were provided for BLOOD TEST ABNORMAL (Blood test abnormal) and INFLAMMATION (Inflammation).    No concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information were provided.
At 0600,  20 hours after receiving the vaccine I arose from bed, like I always do, I took 2 steps and the next thing I remember is opening my eyes and my face was on my hand. I lost consciousness for 5-10 seconds. I fell headfirst into a piece of furniture. My forehead received a hard impact on the edge of a chest and a wound about 4 inches in length opened up over my L eye. I also hit my mouth and nose on the furniture and one of my front teeth became loose.    My ribs on both sides of my chest hit pieces of furniture as I fell forward. I was unable to do anything to break my fall. After a few seconds upon opening my eyes I realized where I was and a blinding pain seared into my awareness. The pain was so intense that I couldn't' move at first. I slowly got up while feeling a stream of blood falling on to my hand. I cleaned myself up and went to a local hospital. I didn?t feel dizzy or lightheaded when I stood up to go into my bathroom to look in the mirror at what had just happened.
Patient experienced mini stroke- patient was slurring speech and had numb lips. Starting plavix. Patient is recovering well.
Heartrate increase; This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was unknown.   The reporter considered the heart rate increased to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced heart rate increases from Shingrix.
Information has been received from a physician concerning a 13 year old female with no previous migraine episode nor drug reactions/allergies who on 10-JUN-2009 was vaccinated IM with the first 0.5ml dose of GARDASIL (Lot#660391/0063X). Concomitant therapy included tretinoin (manufacturer unknown) for the treatment of acne. On 14-JUN-2009 the patient had a migraine attack. The patient had a severe headache, nausea, vomiting and phobia. The patient was at the emergency room at a hospital and responded well to medication. The patient received IV TORADOL for pain and IV ZOFRAN for the nausea and vomiting. Lab diagnostics studies performed: complete blood count, C reactive protein, basic metabolic panel - all unremarkable from the report from the unspecified emergency room physician. On 14-JUN-2009 the patient was recovered. Follow-up information has been received from a physician concerning a 13 year old female student with no pre-existing allergies, birth defect, medical conditions and no illness at time of vaccination who was vaccinated IM in the left deltoid with the first dose of GARDASIL (Lot#660391/0063X) at 15:30 pm in the afternoon on 10-JUN-2009. On 14-JUN-2009 in the morning the patient experienced migraine-like episode with severe headache, photophobia, nausea and vomiting, starting between 3.5 to 4 days after first GARDASIL injection. The patient required intravenous TORADOL and ZOFRAN for relief. The patient had no previous migraine history and none since then. The patient sought medical attention by visiting emergency room. The lab diagnostic tests performed: complete blood cell count, serum C-reactive protein test and metabolic marker test were all normal. The patient recovered on 14-JUN-2009. Additional information is not expected.
He had soreness at the injection site area almost immediately. He woke up with aches, chills, and a slight to medium headache around 4:00 a.m., and was definitely feverish (hot to the touch) by 8 a.m. He's unusually tired. He has mild chills and a mild headache (it's 12:11 p.m. on the 24th, so about 20 hours after the vaccination.) This is his 2nd Covid booster and his first Moderna dose. He previously had  Pfizer for his 2-series vaccination and first booster. His first Covid booster was in late December. (I selected dose number in the series as 4--two primary and two boosters.)
Sudden fatigue within weeks of covid booster. Symptoms persist 3 months later and labs indicate reactivation of EBV/mono
This spontaneous report as received from a pharmacist refers to a patient of unknown age (linked to case 1212USA009419, same reporter). The patient was subcutaneously vaccinated with ZOSTAVAX (lot number 671610/1164AA and expiration date 19-OCT-2012) on 18-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-DEC-2012 the patient received expired ZOSTAVAX. No adverse event was reported. No treatment information was reported. Additional information has been requested.
Patient reports headache, nausea stomach upset along with weakness seen at "medical center" 11/19/07 - Reports M.D. said unsure if reaction from flu and patient was released; 12/20/07 F/U all made and patient fully recovered.
This spontaneous report was received from a nurse practitioner regarding a patient of to a 65 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details unknown). "Confirmed not GARDASIL". No adverse symptoms were reported. Additional information has been requested.
got Covid; got Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2020US313487 (Novartis).  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "got Covid".His nose has continued to run since his second shot.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Papulovesicular vaccinia reaction, onset in morning of 03 Mar 2012.  Rash worsened and led to emergency department evaluation and subsequent hospital admission on 04 Mar 2012.  Patient was discharged on 05 Mar 2012.
Patient received vaccine from Student Nurse on 11/6/08.  Instructor present and cosigned paperwork.  Patient contacted HD on 11/18/08 at 9:00am and reported that she has had pain in arm since vaccination.  She stated that she saw her private Physician who informed her that she was not sure what was wrong with the injection site but that it could be infected and could potentially be Staph.  Dr. prescribed Bactrum.  Patient stated that she is beginning to lose the use of her arm and that the arm surface is pink and warm to the touch.  Advised patient to keep in contact me the Health Department.
Patient put their DOB as 4/25/2001 in order to schedule vaccine. was given Moderna. When returned for 2nd dose we verified ID. His DOB was in fact 2004 so he wasn't of age. We did not give 2nd dose.
Found face down in pack n play, gray and unresponsive. Called 911, taken by ambulance to hospital, airlifted to another hospital.
About 2 days after I got the vaccine, my arm was sore and I had a pretty bad headache. About 6 days later, my ears and throat would get itchy and it felt like my ear and throat would close. I've taken allergy meds for the reaction, but I have not seen a doctor yet.
"I had side effects from the flu vaccine - symptoms body aches, sore throat, chills and nausea" - next day.