chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Breakthrough  Moderna Dose 1 2/9/21 (013M20A) Moderna Dose 2 3/9/21 (040A21A) COVID Positive 8/24/21  8/24/21: History is obtained from patient as well as the personal review of records. speaks limited English.  Video interpretation services used for translation.   She is 76-year-old with known history of diabetes mellitus, hypertension, chronic kidney disease, carotid stenosis and other medical problems.  She has chronic kidney disease stage 3. Her serum creatinine on 7/8/2021 was 2.59.  Follows with nephrology team.   She had cough, nausea, or diarrhea and generalized body pains for 5 days.  She tested positive for  SARS-CoV-2 on 8/19/2021.  Her breathing became worse.  Any activity would make her short of breath.  Diarrhea was resolving.  She had a virtual visit with primary care provider.  She was advised to go to emergency department for worsening shortness of breath.  She was found to be hypoxic and required oxygen supplementation.  Her renal function has become worse.  Serum creatinine was 4.86.  She also had elevated troponin and proBNP.  Denied current fever or chills.  She reported getting vaccinations for  SARS-CoV-2.  8/28/21: Patient is being discharged home and will need to be in isolation at least 10 days.  She needs to follow-up with surgery team for outpatient colonoscopy.  She should follow up with her PCP in 1-2 weeks, nephrology as scheduled.
Shortness of breath about 6-8 hours after injection that lasted for 1-2 hours. Used inhalers when younger, but not since then. First time having shortness of breath episode that patient remembers. Denies history of chest pain, rash, abd pain, n/v/d. Self resolved. Did not seek medical treatment.
72y.o. male with orthostatic hypotension presents with generalized weakness from home. He has not been eating or drinking much at home and felt weaker. He was admitted with covid 19 as well. He declined any treatment for covid 19. He remained on room air without respiratory issues. He had hyponatremia and hyperkalemia which improved. He was followed by psychiatry as well as nephrology. He had orthostatic hypotension which improved gradually with midodrine and salt tabs as well ace wraps and cmopression stalkings. Discussed if comprssion stalkings were to tight not to wear. He did have ace bandages used as wraps aslo which helped. Patient is deemed medically stable for discharge
patient shown tremor 5 min after getting vaccine, patient was saying she didn't eat anything from morning.
Patient stated that she had pain in her left shoulder and was unable to move her arm. Patients pain started a few hours after injection. Patient was given tramadol for her pain.
Received Flu vaccine (AFLURIA o.5cc) in Left deltoid on 9-24-09. Today on 10-8-09, Patient complains of residual taking Excedrin and soaking in warm bath. Pt. states she had no swelling, fever, chills. I recommended taking Ibuprofen or Aleve and f/u with physician.
Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014 at GPV. The patient received FLUZONE 5 days before 6 months of age. (No other information was provided regarding the patient).  No adverse event was reported. List of documents held by sender: none
Received flu shot and Covid bivalent booster from pharmacy on 10/11. On Sunday I started having abdominal cramping and nausea. Abdominal pain continued into Tuesday. Went to the ER and had to have an appendectomy.
Patient fainted about 3-5 minutes after vaccination.  He recovered consciousness in less than a minute.
Information has been received from a consumer concerning his 26 year old girlfriend with an occasional migraine, who was vaccinated with the complete series of GARDASIL. Concomitant therapy included hormonal contraceptives. Beginning either after the first or second vaccination, she began to experience headaches, depression, nausea, physical pain, crying, migraines, vomiting, and had became "a shell person". The patient was hospitalized overnight for a spinal tap. At one time she was going to the emergency room 3 times a week. She has had a battery of medical tests that included a MRI, an EKG and a spinal tap which all came back normal. The reporter stated that the GARDASIL had ruined her life, her career and his relationship with her. The patient has been treated with many unspecified medications. The patient present status is not recovered. The patient sought medical attention. Ruined her life, her career and relationship were considered to be disabling. Additional information has been requested.
Fully vaccinated with Moderna vaccine x 2. Tested positive for Covid on 02/08/2022. Admitted to Medical Center on 02/08/2022. Expired on 02/20/2022 while still hospitalized.
5-4-21 11:15AM; feeling flushed, taste of rubbing alcohol on tongue, sinus pressure, nose bleed. Followed by nose bleeds with blowing nose. Tongue turned blotchy white 4-13-21 approx. 11:30AM; taste of rubbing alcohol on tongue.
17 year old was given a dose of Moderna that, at this time, is only recommended for those 18 years of age and older.  Per phone conversation with mother, the child had no adverse reactions to this vaccine.
Patient received vaccine - several minutes later - he reported dizziness and was sweating profusely. He also reported not being able to breathe and emergency responders was called right away.
Pt received immunization on 10/17/2008.  On 10/18/2008, pt noted itching and welts to left upper arm near injection site.  As this was a Saturday and our office was closed, she did not present to our office until Monday, 10/20/2008.  On this date, she did still have some minor welts present, however, she did states her symptoms had greatly improved from over the weekend.  Patient did have a golfball sized welt to her left inner arm which was pink in color.  Pt did report some itching to the area.  Pt also had a few smaller pink area to her upper arm which were much lighter in color.  Pt did not take any medication for the itching and symptomts were resolving on their own.
This is a spontaneous report received from a contactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient reported fatigue (patient a little tired), and somnolence (just wanted to sleep), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering the plausible temporal relationship.  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.
Patient consented to and received first dose of Moderna Covid vaccine. Family members arrived later that afternoon and stated that the patient had received both shots of Pfizer Covid vaccine earlier in the year.
12:45PM on 03/15/2006 received 3rd Hepatitis B shot in right deltoid muscle.  One hour later tingling in upper jaw and pain in lower jaw on scale of 1-10 pain noted at 8 - I can hardly chew at 2:35PM pain continues.  States no history of recent illness of infections, only medicine on actinel  for osteoporosis.  Advised to call her doctor.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Lot number: GH9703) at the age of 33 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ASHWAGANDHA; MOUNJARO. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19: Brand: Paxlovid, Treatment start date: 07Dec2022, Treatment stop date: 11Dec2022. The other medication in 2 weeks product brand was goli. The patient had no known allergies.
Patient received meningococcal vaccine on 08/12/2003 at physical for college.  On 08/13/2003 developed headache with sensitivity to sound/light sensitivity.  Headache has remained constant since that time.  On 08/23/2003 patient developed blurry vision with headache and fatigue.  (CAT scan of head negative).
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 51 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (29Jun2022) positive, notes: positive test, four days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: No Other medication in 2weeks.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left 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'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 Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient received Paxlovid from 03Oct2023 to 07Oct2023. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe headache at the top of the skull and behind the eyes, especially the right eye. Pressure sensation in sinuses and behind eyes - "like eyes were being pushed out of my head".  Headache lasted 36-38 hours after the injection.  Chills, night sweats, fever of 100F, aching muscles, restlessness, trouble sleeping due to physical discomfort - symptoms lasted nearly 12 hours overnight and into the next morning approximately 24-26 hours after the injection.  Severe muscle pain in arm of injection site within 24 hours of injection. Pain has diminished within 48 hours but is still residual.
Patient with large circular reaction at site of injection. No induration, but hard to touch with dusky/ecchymotic color and bright red ring on outside of lesion. Lesion diameter approx 4 cm. No systemic symptoms. Treated with steroid topical cream.
Dizziness and tingling.  Vitals; 08:08 am: BP=149/108, O2 SAT RA= 98%, HR= 87; 08:15 am: BP=158/90, O2 SAT RA= 98%, HR= 89; 08:22 am BP=158/79, O2 SAT RA= 96%, HR= 88
Sudden onset pain in injected arm into shoulder, chest, back, neck & jaw, chest pain and tightness, exacerbated by laying down and deep breathing. Relived only by nitroglycerin.
Initial information received from a healthcare professional on 31 October 2012. A 56-year old female patient, who had no acute illness at the time of vaccination and no known allergies, had received an intramuscular dose of FLUZONE (Batch number: UH716AA) on right deltoid on 10 October 2012. The patient's concomitant medication included NEXIUM, NASONEX, Gabapentin, ADVAIR, "Alprazalem" (Alprazolam) and "Trasalone" (Trazodone). On 14 October 2012, 4 days after vaccination, the patient had quarter size bruise on right shoulder. No medical intervention. Laboratory details were none per reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
Extreme pain in my joints.  Unable to retain a grip with my left hand.   After the 2nd shoot I developed stabbing pain throughout my lower back, hip joints and in my elbows and hand.   Couldn?t walk without limping for 3 weeks.  Still have shooting pain in my left elbow and right hip with occasional muscle spasms
Information has been received from a nurse concerning a 70 year old female with a history of hypertension, coronary artery disease, osteoarthritis and gastrooesophageal reflux who on 20-OCT-2008 was vaccinated with the second dose of PNEUMOVAX 23, intramuscularly. Subsequently, the patient developed an injection site reaction. The arm was swollen, red and tender. Additional information has been requested.
Moderna COVID19 Vaccine: Headache started within an hour of injection. Hour 4 soreness in arm of injection. Hour 6 chills started. Woke up every 1.5 hours throughout the night, felt feverish, heart beating heavily. Hours 15-34 continuous nausea, vomiting/dry heaves (7 times during this time frame), headache in the forehead with pressure between the eyes and in the nose area, very weak and light headed, aches in upper back/shoulders/neck/base of head, temperature 99.6, no appetite (ate 2 bites of dry toast and drank 30 oz. of water). Hour 35 no more nausea and was able to eat 6 small pretzels. Hours 36-40 was able to sleep peacefully. Hours 41-45 slight headache, temperature 99.2, achiness, stomach cramps, slightly fatigued Hours 46-71 stomach cramps and occasional diarrhea
Pt adm 1st dose of Hep B vax (recomb) SC on 15NOV90; @ time of report there were no other adverse exp reported; No further details were provided;
Case number PHEH2014US004156 is an initial spontaneous report received from a consumer on 27 FEB 2014. This case refers to a 10 year old male patient whose medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was intramuscularly vaccinated with FLUCELVAX (batch number: not reported) on an unknown date in early JAN 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 27 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
felt so good that she has never been more energetic in her life; she felt like she was coming down with the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu) and THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu). On 27-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life). On 27-Jan-2021, INFLUENZA LIKE ILLNESS (she felt like she was coming down with the flu) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (felt so good that she has never been more energetic in her life) outcome was unknown.            No concomitant medication information were provided. No treatment information were provided.   This case was linked to MOD-2021-335962, MOD-2021-335982 (Patient Link).
Narrative:  Unknown if the patient passed away as a result of the vaccine however, it is being reported as an Vaccine Adverse Drug Reaction since the patient passed away within 42 days of receiving the vaccine.
nausea & throwing up on 3rd capsule; has recovered; has sl cramping;
2 weeks after injection, itchiness at point of injection, swelling, red'; symptoms are ongoing
shortness of breath/Difficult breathing; chest pain; stomach pain; 30 minutes after injection dizzy; chills; body aches; nausea; severe headache; vomiting; sweats; fever; slight cough/severe cough with the previous symptoms; This is a spontaneous report from a contactable consumer (patient). A 48-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: ER3730) via an unspecified route of administration, administered in Arm Left on 23Mar2021 17:30(age at vaccination 48-years-old) as dose 1, single for covid-19 immunisation and administered Facility was Pharmacy or Drug Store. Medical history included chronic obstructive pulmonary disease, hypertension, anaemia, fibromyalgia, depression, anxiety, asthma. Concomitant medication(s) included fluoxetine hydrochloride (PROZAC); trazodone (MANIUFACTURER UNKNOWN); vitamin d3 (MANIUFACTURER UNKNOWN); esomeprazole magnesium (NEXIUM), salbutamol sulphate (ALBUTEROL) received within 2 weeks of vaccination. The patient past drug history included Bactrim, cipro (ciprofloxacin) and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not receive any other medication within 2 weeks of covid vaccination. The patient did not diagnose with covid-19 prior to the vaccination. The patient did not test for covid-19 since the vaccination. On 23Mar2021 18:00(30 minutes after injection) the patient experienced dizzy, chills, body aches, severe headache, nausea, vomiting, sweats, fever, slight cough/severe cough with the previous symptoms. On 26Mar2021 the patient had shortness of breath/difficult breathing, chest pain, stomach pain. The patient did not receive any treatment for the events. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient had local swelling and bruising at the site of the vaccination. It was approximately 10 minutes after the shot when checking on the patient that it was noticed. Swelling was about the size of a 50 cent piece.
Thursday 5/10/12 I received a Tdap immunization at medical office on Friday 5/11/12 I started w/pain & redness in my right arm and a severe headache. Headache is still continuing even w/ taking ALEVE. Redness & swelling of Rt arm continued. Took BENADRYL & ZYRTEC over the weekend last night started w/ swollen lymph nodes under Rt arm.
Received first dose of Covid-19 vaccine and tested positive for Covid; This is a spontaneous report from a contactable consumer (patient herself). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205) via an unspecified route of administration on 15Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history was none, and concomitant medications were not reported. On 24Mar2021, the patient tested positive for covid (sars-cov-2 test positive). The patient was scheduled to get the second dose three weeks later 05Apr2021. The patient wanted to know if it is still ok to get the second dose of the vaccine even after tested positive for Covid. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.