chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; neck pain; feeling bad after the Covid Vaccine; headaches; Has been tough on her emotionally and psychologically; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 93 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1: MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "flu like symptoms"; NECK PAIN (non-serious) with onset 2021, outcome "not recovered", described as "neck pain"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling bad after the Covid Vaccine"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "headaches"; AFFECT LABILITY (non-serious) with onset 2021, outcome "not recovered", described as "Has been tough on her emotionally and psychologically".  Additional information: consumer is the patient son, reported the his mother took the Pfizer covid-19 vaccine by which she felt bad after covid vaccine. she got the shot at 3-4 weeks ago  on Friday or Saturday. caller states that patient has been having neck pain, headaches, and feeling like she has flu on and off and also states that symptoms are up and down some days she feels great and some times tough on her emotionally and psychologically.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
C/O STIFFNESS IN LEFT TEMPORAL LOPE;ANTERIE L EAER AND LEFT CERVICAL. PRESSURE IS CONSTANT AND LOCALIZED. DENIES PAIN/PRESSURE BEHIND LEFT EYE. PT C/O NUMBNESS DOWN LEFT ARM AND WRIST. STIFFNESS/PRESSURE REAMINED THE SAME.   RX; BENADRYL PO AND F/P W PRIMARY CARE DR
Feeling of not quite there.  Problem of focusing after rapid movement. Disoriented in bed when turning on my left side.   Feeling of not quite there occur each morning. But, get less servere as the day progressive. Symptoms occur mostly with movement.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient was not received other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Antiviral details reported, the patient received Paxlovid (Lot number: YHF) for COVID-19 treatment from 02Aug2022 to 07Aug2022. BNT162B2 lot number was not reported because lot number was obscured by other product labelling. On 11Aug2022 20:00, the patient was re-infected. Adverse event was not resulted in physician office or emergency room visit. The patient was not received treatment for adverse event (as reported). The patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11/18/21 presents to EC ED for "worsening SOB". PMHx of "HTN, IDDM, CAD"
Lightheaded; tongue tingling; slight difficulty swallowing; occasional cough. Evaluated by emergency department.
Adverse event information provided in this submission, is per a report received by the local County Public Health Department from a submitting facility. Covid-19 vaccination information is from the Immunization Registry. Pfizer 9/10/2021 Lot # FC3183  Pfizer 2/28/2022 Lot # FK9894  Pfizer Comirnaty 8/25/2022 Lot # FW1330   Patient seen in ED at the local Medical Center,  and transferred to another Medical Center. Patient was positive for COVID-19 11/14/2022. Last vaccinated Pfizer Comirnaty 8/25/2022 Lot#FW1330. No further information is known or has been received on the outcome of this patient. For any further or additional information, please contact the reported medical centers.
no appetite; severe fatigue; slept 32hs; not able to walk; legs were so weak that she had to crawl; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 32hs), GAIT INABILITY (not able to walk), MUSCULAR WEAKNESS (legs were so weak that she had to crawl), DECREASED APPETITE (no appetite) and FATIGUE (severe fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a, 038a21a and 004m20a) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), AMLODIPINE BESILATE (NORVASC), METOPROLOL TARTRATE, METHOTREXATE SODIUM (METHOTREXATE ACCORD), CALCIUM FOLINATE (LEUCOVORIN [CALCIUM FOLINATE]) and ABATACEPT (ORENSIA) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced SOMNOLENCE (slept 32hs), GAIT INABILITY (not able to walk), MUSCULAR WEAKNESS (legs were so weak that she had to crawl) and FATIGUE (severe fatigue). On an unknown date, the patient experienced DECREASED APPETITE (no appetite). At the time of the report, SOMNOLENCE (slept 32hs), GAIT INABILITY (not able to walk), MUSCULAR WEAKNESS (legs were so weak that she had to crawl), DECREASED APPETITE (no appetite) and FATIGUE (severe fatigue) had not resolved.            Patient took biologics for arthritis Treatment information was not provided.
Patient reported syncope on the evening following vaccine administration  She collapsed and experienced significant bruising and reported to the Emergency Department for evaluation.
Tiny fatigue; This is a spontaneous report from a contactable Other HCP (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included fluorouracil (EFUDEX, Strength 5%) Topical.  The patient received 1st dose of vaccine on 18Jan2021. 2nd dose scheduled for 09Feb2021. The patient stated "as far as side effects, nothing really. Tiny fatigue". He stopped his Fluorouracil/Efudex 5% chemo topical skin cream drug last night (24Jan2021) since he was not sure if he should continue to use with the vaccine. He had a "teledoc" appointment with his dermatologist on weds and will further discuss. He was asking if there was any "negatives to using cream after vaccination", or contraindication. The outcome of event was unknown.  Information on the lot/batch number has been requested.
patient is a 19 y.o. female with history of hypothyroidism, prediabetes, GERD, anxiety and depression and obesity who recently underwent gastric sleeve bypass 7/31/2021 and now presents with chest pain and shortness of breath on exertion. Patient reports on and off chest pain for two days, no SOB, diaphoresis, blurred vision, or dizziness. Says this resolved without intervention. She reports the episodes of chest increased in frequency and intensity, radiated straight through to her back and up into her neck. She even noted accompanying SOB with exertion. Says at one point she thought she was having a heart attack so presented to the ED for further assessment. Denies sick contacts. Reports no issues with her surgical incisions. Has been following her post-bypass diet. In the ED she was afebrile, vital signs stable.    Of note, patient received first dose of COVID-19 vaccine 7/22/2021.  She was admitted for further care and work-up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Copd" (unspecified if ongoing). Concomitant medication(s) included: ANORO. Past drug history included: Doxycycline, reaction(s): "known allergies: Doxycycline", notes: known allergies: Doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Oct2022) Positive, notes: Still testing positive 14 days after initial symptoms; (20Oct2022) Positive, notes: Tested positive again 3 days after course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient vaccine received and other medication in 2weeks. Vaccine lot unknown reason was Not available/provided to reporter at the time of report completion.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have been feeling clammy and ache all over my body for 2 days at the time of reporting. I am also fairly weaker and have significantly less stamina. I take advil to help with the aching but it does not fully counteract the aching pain.
Pt accompanied with mother to receive first dose.  Pt tolerated well at the time of vaccination.  Pt had dizziness and 'feeling hot' while at the observation area.  Pt brought back to an exam room to be examined by Dr  Dr. and MOP confirmed that this issue was because pt didn't eat anything today.  Vitals taken at 1255 are B/P: 91/56, P: 92, SPO2: 100%.  Pt states pain is localized to the site of injection and was minimal.  Dr. required vitals every 15 minutes for the next hour.  Vitals at 1310: B/P: 110/73, P: 77, SPO2: 99%, pt reported no dizziness at this time.  Vitals at 1325: B/P: 117/72, P: 79, SPO2: 100%.  Vitals at 1340: B/P: 108/73, P: 85, SPO2: 98%.  Vitals at 1355: B/P: 111/75, P: 86, SPO2: 98%, pt denies dizziness, pain or nausea.  Dr. reviewed vitals taken and assessed pt prior to discharge.
The patient answered "no" to immunosuppressive therapy. After vaccination, it was discovered he is taking IMURAN 50mg daily.
Patient presented to office on 6/29 for a physical exam where she received the Pneumococcal 23 vaccine. Later that evening she called stating  her left arm around the injection site was swollen and warm to touch but denied redness. We advised her to apply ice to area and take Tylenol. Patient then called back the following morning with additional swelling, at which point we seen her in the office on 7/1/20. She presented with left arm swelling and itching. We reassured her this was a local reaction and that there was no evidence of infection or severe reaction.
Life changing reactions to my body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Life changing reactions to my body) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Life changing reactions to my body). At the time of the report, VACCINATION COMPLICATION (Life changing reactions to my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Name of reporter/patient provided
Intraparenchymal hemorrhage (May 2021);  Vaccinated (January / February 2021 with Moderna) Patient reported this as an Adverse Reaction via reporting system  Discharge Provider: Primary Care Provider: Admission Date: 5/28/2021 Discharge Date: 5/30/21 Active Hospital Problems:  Intraparenchymal hematoma of brain (HCC);  Spontaneous intraparenchymal intracranial hemorrhage, acute (HCC)   PRESENTING PROBLEM: Brain bleed (HCC) [I61.9] Spontaneous intraparenchymal intracranial hemorrhage, acute (HCC) [I62.9]   HOSPITAL COURSE: A 42 year-old that presented with headaches and olfactory auras with a head CT that demonstrated acute to subacute right mesial temporal intraparenchymal hemorrhage with a rim of surrounding edema. CTA was negative for vascular pathology and MRI Brain with and without contrast demonstrated small developmental venous abnormality arising near hematoma with drainage to vein of galen, otherwise stable hematoma and edema. Patient was given a loading dose of 2g of Keppra and then started on 750 mg Keppra BID. Patient underwent a diagnostic cerebral angiogram which revealed "early opacification of a prominent cortical vein near the mesial temporal region without definitive arteriovenous shunting. Perihematomal hyperemia versus a small underlying mass cannot be excluded". A continuous EEG reading was negative for seizures. The patient was otherwise voiding, ambulating, and tolerating an oral diet, thus deemed medically stable for discharge with follow-up as above.   CONSULTS / RECOMMENDATION: Neurology: patient to follow-up resident clinic for AED management. On maintenance Keppra dose 750 mg.
Benston had the exact same stiffening, seizure like episodes as he had after his 2 month vaccinations.  It was a Saturday morning and he had his first one.  His whole body tightened, his face got red and it lasted about 5 seconds.  It looked involuntary and his eyes got big like he was scared but he didn't cry afterward.  He had two more that same day 3/13 in the afternoon.  Then he had another one on 3/15 in the late afternoon.  That was the last one.
seasonal allergy; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021360431 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization.  Relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing), notes: diagnosed with Chronic Bronchitis prior to getting the 1st dose of the Covid-19 vaccine. The patient's concomitant medications were not reported.  The following information was reported: SEASONAL ALLERGY (non-serious) with onset Mar2021, outcome "unknown", described as "seasonal allergy"; OROPHARYNGEAL PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He is asking if he can take the 2nd dose today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever x 5 and days, arthralgias starting 4 days after shots and limp starting day 5.
Headache to the point of thinking self harm lasting over 30 days. Provider gave beta blockers and pain meds to relieve pain to break the cycle.  Chest pain went to the Ed completed ekg, then see internal medicine specialist.  Chest pain current.
injected a patient over 7 years of age with a daptacel instead of a boostrix by accident with no reported adverse event; injected a patient over 7 years of age with a daptacel instead of a boostrix by accident with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old female patient who was injected with a diphtheria-15/tetanus/5 AC pertussis vaccine (Daptacel) instead of a boostrix by accident patient over 7 years of age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Aug-2023, the suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection lot C'6013AA expiry date: 05-Jul-2024 via unknown route in unknown administration site for prophylactic vaccination (strength, dose: unknown), was injected a patient over 7 years of age with a daptacel instead of a boostrix by accident with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events (wrong product administered and product administered to patient of inappropriate age).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Red rash on arm below injection site, first occurred on day 8 (today is day 11 still have it, but it is lessened), hard lump under the skin,  itching sensation at first, followed by burning sensation.
Blisters on his upper shoulder, around the waistline, (both sides), buttocks, arm and back; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular). On 25-MAY-2023, 2 days after receiving Shingrix, the patient experienced blister (Verbatim: Blisters on his upper shoulder, around the waistline, (both sides), buttocks, arm and back). The patient was treated with cortisone cream. The outcome of the blister was not resolved.   It was unknown if the reporter considered the blister to be related to Shingrix.     It was unknown if the company considered the blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The reporter was a patient. The reporter stated that after 2 days of vaccination with Shingrix he developed blisters on his upper shoulder, around the waistline both sides, buttocks, arm and back. The patient described as reddened blisters that the pharmacy told him to put Cortisone cream on to help it feel better. The patient reported that the blisters were ongoing. The patient asked if this was normal as a side effect, gave medical disclaimer. Referred to HCP. Spoke per PI and content. The reporter requested to consent the follow up.
Pt received a DT vaccine, at her left deltoid muscle site. 1-2 days later developed redness, swelling, pain at the injection site.
This spontaneous report was received from a registered nurse and refers to patients of unknown demographics. On an unknown date(s) on or after 17-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX (lots # M047661, expiry date: 02-DEC-2018, M038856, expiry date: 14-SEP-2018, M033907, expiry date: 20-JUL-2018 and M025864, expiry date: 24-MAY-2018) for prophylaxis. The temperature excursion details for lots # M047661 (expiry date: 02-DEC-2018), M038856 (expiry date: 14-SEP-2018), M033907 (expiry date: 20-JUL-2018) and M025864 (expiry date: 24-MAY-2018) included: Temperature range: 15 degree Fahrenheit (F) to 46 degree F (-9 degree Centigrade (C) to 8 degree C): 5 hours 44 minutes on 17-MAY-2017. Temperature range: 6 degree F to 14 degree F (-14 degree C to 10 degree C): 9 hours 47 minutes on 18-MAY-2017, 9 hours 7 minutes on 19-MAY-2017, 9 hours 37 minutes on 20-MAY-2017, 9 hours 35 minutes on 21-MAY-2017, 9 hours 7 minutes on 22-MAY-2017,  9 hours 19 minutes on 23-MAY-2017, 9 hours 42 minutes on 24-MAY-2017, 9 hours 39 minutes on 25-MAY-2017, 9 hours 21 minutes on 26-MAY-2017, 9 hours 57 minutes on 27-MAY-2017, 10 hours 5 minutes on 28-MAY-2017, 10 hours 1 minutes on 29-MAY-2017, 9 hours 50 minutes on 30-MAY-2017, 9 hours 32 minutes on 31-MAY-2017, 9 hours 26 minutes on 01-JUN-2017, 7 hours 0 minutes on 02-JUN-2017, 6 hours 30 minutes on 21-JUN-2017, 11 hours 3 minutes on 22-JUN-2017 and 6 hours 43 minutes on 23-JUN-2017. Cumulative totals: 175 hours 35 minutes Information regarding previous temperature excursion was reported as undetermined. The call was due to a Digital Data Logger. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
No fever, redness and swelling from injection site to approx. 1 inch of elbow. Client not c/o pain or discomfort.
1045 Flu Mist, 11:15 c/o headache. Fainted at 1:15.
12:18pm Patient reports sense of numbness in lips, unsure if it is anxiety 12:25pm Vitals Taken HR 72, BP 132/70, O2 100% Denies any dyspnea, denies any tingling to lips and tounge. No other sx 12:30pm 15mL liquid Benadryl given 12:45pm Patient denies any worsening of sx 12:50pm Patient reports senesation of numbess to tonge is resolving 1:00pm Patient verbalized that she is feeling fine and feels well enough to go home. She is aware if symtpoms return or worsed then she should seek medical attention.
This spontaneous report as received from a nurse refers to a 32 year old patient of unknown age and gender. Concurrent conditions included tobacco user and diabetes mellitus. No medical history, allergy/drug reactions and concomitant medications were reported. On 07-JUN-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L035882 expiry date: 19-APR-2017 (dosing details and route of administration were not reported). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history was reported. On 15-NOV-2013, the patient was vaccinated with VAQTA strength 25/0.5 (unspecified units) dose 1, 0.5 ml, intramuscular. Concomitant therapy was not reported. On 02-MAY-2014, the patient was vaccinated with second dose of VAQTA. No adverse effects reported. No Product Quality Complaint was involved. Additional information has been requested.
Firmness of soft tissue, tender, redness, and a 3 1/2 cm lump.
1 hr p/vax given eyelids swollen nearly shut redness noted of face, chest, stomach & legs; welts on chest; pt seen by MD; pt had white area on sclap size of goose egg w/redness around & reports hurts; also urticaria, allerg react, edema;