chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 4 year old female with no pertinent medical history who on 06/07/00 was vaccinated with a dose of varicella virus vaccine live (Lot # 634842/1867J).  There was no concomitant medication.  The child came into the office on 12/10/03 and reported that two days ago, on 12/08/03, she developed 1 or 2 pimples on her chest. On 12/10/03 they were also on her abdomen and the number increased to 6-7. She also had some in her groin and a couple on her arms. It was reported that they itch and hurt. No labs or diagnostic test were performed. No product quality complaint was involved. Additional information has been requested.
never got the second shot; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 1 year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comments: The reporter was a  healthcare provider. A patient received first dose of Shingrix and never got the 2nd dose. The reporter asked should they start the 2 dose series over. The reporter stated that he/she would not like to disclose more than at this time. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Generalized body ache. Mild closing of throat happned 2x. Vaccine site swollen, warm to the touch, tender, Red. Chills .
Diagnosed with shingles; Serious pain; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Diagnosed with shingles), PAIN (Serious pain) and RASH (Rash) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Diagnosed with shingles), PAIN (Serious pain) and RASH (Rash). At the time of the report, HERPES ZOSTER (Diagnosed with shingles), PAIN (Serious pain) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.    Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-JUN-2021 and reporter's causality was updated.
Fever; Chills; fatigue; Weakness; Pain; This is a spontaneous report from a non-contactable pharmacist. An adult male patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in Mar2021 as a single dose for COVID-19 immunisation. Medical history included migraine and seasonal allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in Feb2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to vaccination. On an unspecified date in Mar2021, the patient experienced fever, chill, weakness, fatigue and pain. It was unknown if the patient had tested positive for COVID-19, prior to vaccination. Since the vaccination, it was unknown whether the patient had tested positive for COVID-19. It was unknown if the patient receive treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever, chills, fatigue, weakness and pain was recovered after 3 days on an unknown date in Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
an enlarged heart which made him pass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CARDIOMEGALY (death), outcome "fatal", described as "an enlarged heart which made him pass". The event "an enlarged heart which made him pass" was evaluated at the physician office visit. The patient date of death was unknown. The reported cause of death was cardiomegaly. It was not reported if an autopsy was performed. Clinical course: The booster shot was great only thing that gave consumer's father an enlarged heard which made him pass. He had never had a heart condition and he was the best thing in life. Wondering if there's anything could do to sue or even maybe get some help, mean his doctor even said that's only thing that could of caused it. Wish big pharma had a heart because it ruined the life.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: an enlarged heart which made him pass
Vomiting repeatedly; fever; arm pain; tiredness; headache; not drinking water; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 27Apr2021 at 12:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included autism, anxiety, Attention Deficit Hyperactivity Disorder (ADHD) and asthma. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), clonidine (MANUFACTURER UNKNOWN), budesonide (NASOCORT) and levocetirizine dihydrochloride (XYZAL), all taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. 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 the vaccination. On 28Apr2021 at 04:00, the patient experienced vomiting repeatedly, fever, arm pain, tiredness, headache and was not drinking water. The clinical outcome of the events vomiting repeatedly, fever, arm pain, tiredness, headache and was not drinking water were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist concerning a 54 year old female patient. The patient had no pertinent medical history. It was reported that the patient experienced hives during treatment with KEFLEX. On 23-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (Lot # L013546; expiration date: 17-JUL-2016) (dose and route not provided). On 23-JUL-2015, the patient experienced "7 inch circumference circle" that was warm to the touch at the injection site. Pharmacist reported that the patient stated that it was painful to move the arm where she got the injection and that she had blisters in her mouth since 23-JUL-2015. Pharmacist also reported that the patient felt feverish the "past couple of days". No treatment was given for the patient's adverse events. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered.  The patient sought medical attention by seeing the pharmacist. Additional information has been requested.
Soreness and redness around injections site lasted about 72 hours as to be expected. Within 24 Hours intense stomach cramping and diarrhea / nausea perused. Every morning for the last 2 weeks has been an hour or 2 of flu like symptoms with continual discomfort of digestive system.  Very tired, do not feel like my normal active, happy self.
I reported to my physicians my month long reaction to the 2nd Moderna Vaccine (2/10/21) and they advised that I probably would not react to the booster in November due to the length of time between injections and the fact the booster be half the strength of the original booster. I did file a report with the CDC of the reaction as well. It was similar to the reaction I get when I take prednisone or get injections of steroids. I get facial flushing and surges of very high BP that have to be temporarily countered with clonidine. I have documented norepinephrine surges with facial flushing documented at clinic both on occasion standing and when asleep. Normally these only happen for brief periods except they happen for extended periods of a few weeks when I get prednisone or steroid injections. I have been checked for a pheochromocytoma about a decade ago and I was told I do not have one.  After the booster I had a reaction that was much bigger then the one in Feb. that lasted 8 months. I had to take clonidine at maximum dose for those 8months as I had constant surges of very high BP sytstolicup to 220, facial flushing, increased sweating, hallucinations, and an inability to sleep. I would stay up for 3-4 days straight then sleep maybe 5-6 hours and then stay up for 2-3 days. During this time the max. dose of clonidine was not enough. My Guanfacine was doubled. That was not enough either. Losartam was added by my direct care dr. at 25 mg. And later double to 50 mg. After 8 months I was able to come off the clonidine so I say the reaction was 8 months long however, I only recently was able to go down to 25 mg. Of losartan and am still on the double dose of Guanfacine. My sleep pattern only returned to normal this week.  After the first reaction it took time for all the symptoms to slowly return to near normal. After the booster I felt like I was overdosed on steroids. I have not been on prednisone nor gotten injected steroids during this period. This is all from the mRNA vaccine and booster.  I very much wanted to get the Novavax booster next. I have called them, the FDA and the CDC and been told because I had the Moderna two vaccinee + a booster it is illegal for me to get one.  I am willing to assume the risk. Can I not have an exception?  I am someone who very much believes in masks, distancing, and vaccinations. It is just that the mRNA ones are causing too severe a reaction.
Shoulder soreness, lower back pain, painful knees, generalized muscle soreness, painful neck, sinus congestion with some blood. Symptoms were first noticed upon waking this morning and have no abated as of 2pm.
Recurent uveitis p/receiving fluogen; pt had complicated surgery on lt eye w/resultant uveitis; 4mos p/complete recovery recvd vax w/in 2 wks had inflammation w/cystoid macular edema & reduced vision;
My arm had a red dot at the point of injection, my arm has turned red at the site of injection, about the size of your hand and is hard to the touch, still sore, not like the 2nd day but still sore. My husband got his vaccine right before me and did not have the red dot at the point of injection. I had to take off work the 2nd day because I did not feel well.
This case was reported by a healthcare professional and described the occurrence of bad taste in a 41-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 7 November 2007 at 16:45 the subject received unspecified dose of Fluarix (.5 ml, unknown, left arm). Approximately 5 minutes after vaccination with Fluarix, the subject experienced bad taste, pain, vomiting and headache. On 10 November 2007, the events were resolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.  Follow-up information received on 13 December 2007 indicated that the subject felt that the events were related to treatment with FLUARIX, the health care professional did not. The events resolved.
anaphylactic reaction; allergic reaction; swelling face; tongue hurts; difficulty breathing; fast heart beat; rash; swelling of face/throat; sore throat; Pfizer Covid 19 Vaccine booster dose on 6Oct2021/received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; Pfizer Covid 19 Vaccine booster dose on 6Oct2021; received her flu shot and her Pfizer Covid 19 Vaccine booster dose on 06Oct2021 simultaneously; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer (patient) based on information received by Pfizer from a regulatory authority (Manufacturer Control Number#: 202101341896). A female patient of an unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Oct2021 at dose 3 (booster), single for COVID-19 immunisation; influenza vaccine on 06Oct2021 at single dose for flu immunization. Medical history and concomitant medications were not reported. Patient confirmed that she had received her flu shot and her Pfizer COVID 19 vaccine booster dose on 06Oct2021 simultaneously. She explained that she believed that she had been misled by the pharmacist (who administered the vaccines). She explained she spoke to the pharmacist the morning of the report after spending the night in the emergency room (ER) and was referred to Pfizer for guidance. She noted she had been to the ER twice, received an epinephrine injection and was told that was all that could be done for her. The allergic reaction/anaphylactic reaction was described as follows: in Oct2021, her face was swollen, tongue hurt, sore throat, experiencing (almost every side effect on the list she was reading including severe ones) difficulty breathing, swelling of face/throat, fast heart beat and rash all over body. She explained she looked like a monster. Seeking help. She noted that her healthcare professional (HCP) was having surgery, she had no access at that moment to see her doctor. She asked what the risks of the vaccine were and what she should do about side effects. The patient went to the emergency department and received medical treatment, that included epinephrine injection USP auto-injector. The patient was hospitalized for the events in Oct2021. The outcome of the events was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after the vaccine I experienced  sleepiness,  running nose, tiredness.  The following day I experienced body aching, chills, headache. For the last three weeks, headaches, body aching,  swollen legs, loss of appetite,  tiredness, bone aching; my jaws hurting;  nausea;
It stung more than other vaccines. About 4 hrs after shot, arm started getting sore when I performed certain movements such as reaching out and raising it above my head. I stretched it several times in the course of an hour. Soreness and muscle pain got worse. I ate something shortly after I started feeling nauseous  which is still intermittent 18 hrs after shot. Fever about  7 hrs after shot. woke up  16 hrs after with 100.9 fever. It has now reduced to 100.2. I have taken 4 tylenol.
No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported.  No treatment information was provided.
Mom reports pt started having problems a few minutes after being vaccinated. Reports pt started screaming and acting "crazy". Reports since that time had behavior change, biting, throwing tantrums and screaming. Pt is improving almost back to normal now.
No adverse event; Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border).    This case contains information for the 3rd of 3 adult patients described by the reporter.  Patient was not pregnant. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. NDC was provided as 80777-0275-99. No concomitant product was reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698179 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698179:Master case - 1st adult patient
On 10/21/15, the patient had a chiropractor visit (did a standard adjustment of her shoulder blade - no topical products used). On 10/22/15, she came to the pharmacy with itching and extensive redness and swelling at the injection site. She was fine for the week after the PREVNAR infection. It has since gotten much better and is now just a "little pink".
No adverse event.  Dose given too early. Was not due until 10/26/2022.
On or about 8 pm on July 26, 2021, I experience bleeding in my right eye.  I called them the next morning , obtained an appointment for the next day, July 29, 2021, at which I was told I had a posterior vitreous detachment.  I was referred to their retina specialist.  I saw Doctor on August 6, 2021.  He confirmed the diagnosis and examined my right retina for indications of damage or detachment.  He observed no such damage or detachment.  On or about 8 pm on August 17, 2021, I experienced more and much greater bleeding in my right eye to the extent I could barely see shapes of large objects.  I saw Doctor on August 19, 2021.  My retina was fine but he stated he had never seen such extensive much bleeding.  I was unable to see a single letter with my right eye during the visual acuity exam.  I have seen Doctor six more times to monitor the situation.  My retina remains fine.  The blood in my right eye has dispersed and lost most of its color.  My sight has improved to the point that I can play pocket billiards again with no loss of accuracy.  I am scheduled to see him next in January of 2022.  However, today, November 16, 2021, at about 5 pm, I experienced another, but minor, bleeding episode.  I do not detect any retinal detachment symptoms, so I will not bother to see the Doctor until January.  By the way, I stopped taking Ecotrin shortly after the news came out that it was not helpful and could be harmful (blood thinner) for those not at risk of stroke and heart attack.
Arm was swollen and sore after vaccination.  Laid down to rest and fell sleep.  Next day felt terrible all day;  tried to sleep but couldn't.  Last night slept 13 hours straight.   Feels out of norms, has chills on and off.   Patient had problems sleeping because joints pain on ankles, left hip and back of calf, middle of back.  Took 1 Tylenol to help with symptoms.   On Tuesday couldn't even walk.   Started taking 2 Acetaminophen every 6 hours because in excruciating pain.    Today called the doctor and has appointment with orthopedic doctor tomorrow.   This year symptoms were worse than in past years.
No additional AE reported; Temperature excursion; This spontaneous report has been received from a non-health professional and refers to an 18-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot number W017343 verified as valid, expiration date reported and upon internal review established as 13-DEC-2023, administered intramuscularly in the right thigh for prophylaxis (strength was not provided) after a temperature excursion that happened on 01-DEC-2022 at a temperature of 47.9 degree Fahrenheit for 47 minutes (product storage error). No additional adverse event reported.  This is one of several reports from the same reporter.
This spontaneous report as received from a certified medical assistant refers to ten unspecified patients of unknown age and gender. On an unknown date, the ten unspecified patients could have received improperly stored doses of VARIVAX (Merck) (Lot #, dose and route not provided). No adverse effects were reported. Additional information has been requested.
A physician reported that a 6-month-old male received ROTA SHIELD, TRIPEDIA (PMC USA) and ENERIX-B vaccines on 10-FEB-1999. On 15-FEB-1999, the infant developed a rash. He was seen by the physician, who noted large, patchy, raised, erythematous areas on face and body, some measuring 3 to 5 cm. The physician diagnose erythema multiforme. No teatment was prescribed and the infant recovered after 3 days. Copies of this report have been fowarded to PMC USA and SKB, manufacturers of the concomitantly administered vaccines.