chrisvoncsefalvay/vaers-outcomes huggingface dataset:
21 YO PATIENT PRESENTED WITH SEVERE MIDSTERNAL CHEST PAIN. SYMPTOMS STARTED THE PRIOR DAY. HE AWOKE AT 5AM WITH 10/10 PAIN AND SOME DYSPNEA. HE REOPORTED "FLU" SYMPTOMS 48 HOURS PRIOR TO HIS PRESENTATION. IN ADDITION HE WAS FEBRILE ON INITIAL PRESENTATION. HE PRESENTED TO MEDICAL AND WITH HTN BP 150/101. EKG REVEALED DIFFUSE ST-T CHANGES AND POSSIBLE OLD IWMI. CARDIAC MARKERS; TROPONIN AND CK-MB WERE POSITIVE. U/S REVEALED PRESERVED LV FXN NO WALL MOTION CHANGES. PT WAS TREATED FOR HTN AND POSSIBLE ISCHEMIC EVENT. NO LMWH WAS GIVEN AS MYOPERICARDITIS WAS HIGH ON DIFFERENTIAL. PT ADMITTED REMAINED STABLE HEMODYNAMICALLY IN ICU. MEDEVACED TO MC WHERE DX OF MYOPERICARDITIS WAS CONFIRMED. PT RECEIVED SMALLPOX VACCINATION 26MAY08.  7/15/08 Reviewed medical records of 6/5-6/6/2008. FINAL DX: NSTEMI; myopericarditis; HTN Records reveal patient experienced awakening w/substernal chest pain x 1 day.  Had fever, malaise, muscle aches s/p anthrax vaccination w/night sweats x 2 days. Transferred to higher level of care.
I got my Pfizer first dose today and it was fine at first, but four hours later I was slammed with incredible arm and shoulder pain. I have a really high pain tolerance (tore my meniscus 3x with no surgery or pain meds, wasn't too bad) and I'm 24F, not on any medications. I keep reading that sore arms are common, but this is a 6/7 on the pain scale. Putting on joggers was excruciating and I almost vomited. I can't even bring a glass to my mouth with that arm. Even laying as still as possible hurts. I cannot lift my arm past my pelvis and my shoulder is immobile. I feel nauseous when I move it.  I haven't seen this experience anywhere so I am puzzled... I'm fully vaccinated w/ everything else and the closest to this was the tetanus shot, which hurt but not like - this - level of pain. I'm getting a bit concerned that the person who did it (in a hundred car drive thru) missed the deltoid and shot it into my shoulder?? It's VERY high on my arm. I believe in this vax 100% but I can't believe the pain I'm having and why it's not mentioned anywhere.  Like I am so so grateful for this vax and am in awe of the science -- and everyone should get it   -- but I just don't understand why I'm in literal excruciating pain :( Moving it even slightly feel like I'm ripping it from the bone.   It?s now been 20 hours and the pain is worse than ever, even breathing, sneezing or bending over causes searing pain.
Began with symptoms on 7/22/22. on 8/1 family brought to ER as they did not feel they could care for patient any longer d/t increased level of assistance required. Admitted for weakness. Treatment includes: therapy, medication, and assessment.
Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient plus 60 days from 1st dose/a patient that is 60 days past the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medication was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: contains non significant information: Reporter address updated.
within 5 minutes of vaccination recipient felt lightheaded, pounding HR, and general weakness. recipient laid  down, drank some water after 25 minutes, then proceeded to leave. Checked in with recipient at 2:30 PM and the recipient is back to normal no issues
Breakthrough COVID-19 case: I started to have a itchy throat and a slight cough. I did take a rapid test and it came back negative. by 04/24/2022 in the evening I started to have chills and run a fever with 101.2. On 04/25/2022 I rapid test and it came back positive. I called my doctor to advise about my results and asked for medication. the doctor prescribed Paxlovid. After the first day of Paxlovid I did start to feel better, but the next night I started to get chills and run a fever and was coughing. I took some Ibuprofen and went to sleep.
The patient claims she has really severe abdominal cramps 2 days after getting the Moderna vaccine.
This case was reported by a physician via call center representative and described the occurrence of acute derangement of liver function in a 53-year-old female patient who received SHINGRIX. On 23rd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2018, 3 days after receiving SHINGRIX, the patient experienced acute derangement of liver function. On 1st April 2018, the outcome of the acute derangement of liver function was recovered/resolved. The reporter considered the acute derangement of liver function to be probably related to SHINGRIX. Additional details were reported as follows: The healthcare professional reported that patient was not on any medication and did not have any medical conditions that could have contributed to this. On either 26th March 2018 or 27th March 2018, the patient had blood work drawn and liver derangements. The healthcare professional reported that these labs were all normal prior to the patient receiving the SHINGRIX vaccine. On 1st April 2018, the patient had the labs redrawn again and everything returned back to normal and was resolved. The reporter did not have lot number or expiration date.
This spontaneous report as received from a certified medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with an unspecified amount of doses, with unspecified lot number/unspecified expiration date of GARDASIL 9 that underwent temperature excursions starting on 01-NOV-2016 for prophylaxis. No adverse event was reported. The outcome of the event was unknown. Temperature was 47 degree Fahrenheit-77 degree Fahrenheit and time frame was 2 hours 10 mins. Call was due to digital data logger and there was no temperature excursion before. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA006923: US-009507513-1707USA006921: US-009507513-1707USA006922.
Information has been received from a 65 year old female patient referring to herself. The patient's medical history included a back surgery as well as shingles outbreak without the rash in November 2016 for which she was treated with VALTREX (unknown manufacturer). The patient's drug reactions included vomiting with DEMEROL, itching with ROBAXIN as well as itchy rash with cephalexin, AUGMENTIN, and antibiotics. Her historical drugs included an unspecified vaccination on approximately 04-DEC-2016 (reported as 6 weeks prior to receiving ZOSTAVAX). On 15-JAN-2017, the patient was vaccinated with ZOSTAVAX) (1 injection) in the left arm for prophylaxis (route of administration, lot number, and expiration date were not provided). On approximately 16-JAN-2017 (reported as within 24 hours from vaccination), the patient experienced horrible headache, horrid pain in her back and head as well as pain in her hip which was a ''burning, shooting pain that hurts with movement''. The patient also reported that the pain in her hip made it hard for her to take a step sometimes and that on an unspecified date in 2017 (after receiving ZOSTAVAX), she experienced minor sore throat from which she recovered on an unspecified date. On 24-JAN-2017, the patient sought medical attention and visited her physician who put her on a treatment therapy with 40 mg prednisone (manufacturer unknown) injection as well as unspecified oral prednisone. By the time of the report, the patient was recovering from the events of horrid pain in her back, head, and hip as well as difficulty in walking. The patient stated that she was still having the leg pain and the headache; however she stated that it was improving and getting better. The relatedness between the suspect therapy and the adverse events was not reported.
Patient was COVID positive 4/26/2021 and 6/4/2021; Patient was in surgery center about to get a breast surgery done; in Preop her BP was in the 200s and uncontrolled; when wheeled to the OR and placed on monitors; patient suddenly went in to SVT; Adenosine given to break SVT; Procedure was cancelled and anesthesia was not induced; Patient transferred to ER for cardiac consult;
my ears constantly feel like they need to "pop." I hear a crackle when I swallow. This is present all day
Flu-like symptoms including chills, body aches, pain in the bones/joints of my legs. Significant pain and discomfort at the injection site in my arm. Such discomfort and soreness that it was difficult to lift my arm when dressing and undressing. These adverse reactions lasted about 24 hours.
It was reported pharmacy that the patient was hospitalized the day after receiving the second dose of the Moderna COVID-19 dose. Patient was very "loopy and dizzy".
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 at 14:00 as dose 5 (booster), single (Lot number: GJ6665), in right arm and on 20May2023 at 14:00 as dose 6 (booster), single (Lot number: GJ3210) at the age of 79 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2023) Positive; Body temperature: (11Aug2023) 102. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has no known allergies. Began Paxlovid upon testing positive (11Aug2023) with symptoms of 102 fever, aches, cough, headaches and congestion.
My COVID-19 symptoms started on 12/27/2021 in the morning. I had cough, tired, achy, and headaches. I went to a clinic and did a PCR test which was positive on 12/28/2021. At the time I did a telehealth with a urgent care clinic  because my doctor wasn't seeing any patients due to COVID-19. At the urgent care they prescribe me ADVAIR inhaler. I then followed up with my doctor afterwards. On 04/10/2023 I started experiencing lower back pain. My lower back is painful and I have pain in my legs I think I might have fluids in my legs not sure what it is exactly. I have joint and muscles aches. I will be seeing my doctor for this issue on 06/01/2023. I did COVID-19 test 2 weeks ago which was negative.
She, along with her elderly father, around 8 hours after the immunization, experienced swelling of the face and neck. She took her father to the emergency room as his symptoms were similar, but more severe. She was not treated, waited for her father, then both went home.
Patient got shots on 08/23/2005.  DTAP right upper thigh, IPV left lower thigh, MMR # 2 left lower thigh.  Right upper thigh with swelling and redness. Given Benadryl by mouth.
a blood clot in my brain; I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds; I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds; I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): PFIZER INC-202101871718.  A 39 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 (Lot number: FH8028) at the age of 39 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; ARIMIDEX; LEXAPRO; BLUDEC; PROLIA. The following information was reported: CEREBRAL THROMBOSIS (medically significant) with onset 18Dec2021, outcome "unknown", described as "a blood clot in my brain"; HEADACHE (non-serious), SNEEZING (non-serious), COUGH (non-serious) all with onset 18Dec2021, outcome "unknown" and all described as "I started noticing a stabbing pain in the top of my head anytime I cough like sneeze, bend over, jump, I get this real bad stabbing pain in the head that lasts anywhere from 30 to 60 seconds". Therapeutic measures were taken as a result of headache, sneezing, cough. Treatment taken with Ibuprofen 800 mg.  No follow-up attempts are possible. No further information is expected.
Headache, pain in neck and face, general muscle ache, nausea, chill.
I had a period 21 days after first vaccine even though I am post menopausal and have been for 6 years.; This is a spontaneous report from a contactable consumer ( patient reported herself ). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number:ER8727, expiry date:unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 22May2021 at 09:15 (at age of 59-years-old) (DOSE 1, SINGLE for covid-19 immunization. The patient medical history included AC nodal re-entry tachycardia 1991/1993-Heart ablations corrected the rhythm issue and non-small cell adenocarcinoma in right lung 2015.Concomitant medication included calcium carbonate, cholecalciferol (VITAMIN D 2000). The patient previously took midazolam, epinephrine, diphenhydramine, levofloxacin, penicillin and dibromoglutaronitrile, c. 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 vaccine within 4 weeks prior to covid-19 vaccination. The most recent COVID-19 vaccine was administered at Hospital. The patient is not pregnant at time of vaccination. On 14Jun2021 at 15:45, the patient reported she had a period 21 days after first vaccine even though her post-menopausal and have been for 6 years.  The reporter assessed the event as non serious.The event outcome was recovering.
Subsequent to receiving two doses of varicella virus vaccine live, the pt developed atypical chickenpox with fever, headache and a rash consisting of flat red splotches and a few vesicles.
At 12:30 AM woke up with severe chills, shaking, headache. Took 500mg tylenol; fever continued to ride to 102.8. Couldnt sleep. Took more benadryl and tylenol. Severe body aches and chills.  Bouts of nausea and light headedness. Injection site swollen hot and read to touch. I've never been this sick in my entire life I would never do this again.
Bell's palsy for 3-5 weeks; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Post-vaccination, patient experienced Bell's palsy for 3-5 weeks. The clinical outcome of the event was unknown.   Information about batch/Lot number has been requested.
Pt called and report they experienced a red, bumpy, itchy, rash after receiving the vaccine.
as stated by mom: shots given late afternoon, crying constantly x 5 hrs w/jerky movements, uncontrollable jump & refusal to take anything; po t103;
body aches, chills, fever, nausea, abdominal discomfort, headache
Mild to bad head aches almost every day since getting the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the left arm on 19May2021 at 18:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies to medications, food or other products. Concomitant medications were not reported. 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 COVID vaccine. Patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0167) in the left arm on 28Apr2021 at 18:00 (at the age of 39-years-old) as a single dose for COVID-19 Vaccination. On 24May2021 at 12:00 the patient experienced mild to bad headaches almost every day since getting the vaccine. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild to bad headaches almost every day since getting the vaccine was not recovered at the time of this report.
Joint pain; Shortness of breathe; Headache; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breathe), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DYSPNOEA (Shortness of breathe), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site). On 09-Jun-2021, the patient experienced ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) on 09-Jan-2021 for Adverse event following immunisation, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (Shortness of breathe), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: unknown (Positive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event added joint pain. Also patient reported she never experienced the adverse events reported in initial source document and the only event she experienced was joint pain which may or may not be due to vaccine according to her.; Sender'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.
Pt c/o nausea and dizziness.  BP 104/37, HR 53, RR 14.  Pt stable and released from the vaccination site.
pt states that on 1/30 her arm was sore but on 1/8/2021 she developed a red rash from injection site to elbow  that covered the exterior surface of her arm so Pt went to ER at work and they prescribed Keflex.  On 1/11/21  she went to her PCP which gave her a shot of Rocephin and  doxycycline.  She said the rash got better and dissipated by the 1/15/21.  She completed her meds on 1/22/2021.
12 hours post injection, fever, chills, nausea, body aches, lack of appetite. Symptoms began to resolve 24 hr post injection and completely resolved at 48hrs
Site was 6 cm x 6cm, warm, red, tender to touch. Benadryl.
Narrative:  82 yo male reported injection site pain, fatigue and body aches after his first dose of pfizer vaccine on 2/16/2021. Pt reported these ADRs when he  returned for his second vaccine on 3/9/2021. Both vaccines were administered without complications.
No other adverse events reported; MMR II was inadvertently administered with PROQUAD; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 30-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), dose reported as 1 dose, lot # T036563 (Lot No. T036563 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and upon internal validation established as 26-APR-2022) for prophylaxis (dose number, exact dose and route of administration were not provided).  On the same day, the patient was inadvertently administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), dose reported as 1 dose, lot # T003384, expiration date: 28-JAN-2022 (dose number, exact dose and route of administration were not reported) also for prophylaxis (vaccination error).  No adverse events were reported.
Complete deafness in right ear; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: eng199), via an unspecified route of administration, in left arm on 24Mar2021 09:00 (at the age of 56-years-old) as single dose for COVID-19 immunization. Medical history included known allergy to penicillin. The patient received other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant at the time of vaccination. Patient received vaccine at the Pharmacy or Drug Store. The patient experienced complete deafness in right ear on 11Apr2021. Hearing loss was not regained with current aggressive medical care. The event resulted in physician or other healthcare professional office or clinic visit and considered as serious due to disability. Since the vaccination, patient has not been tested for COVID-19. The patient was treated with steroids, several other medications and oxygen. Outcome of the event was not resolved.