chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive COVID-19 test with symptoms/had like a head cold and cold like symptoms/he tested positive for COVID.; positive COVID-19 test with symptoms/had like a head cold and cold like symptoms/he tested positive for COVID.; This is a spontaneous report from a contactable nurse.  A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on left deltoid on 18Dec2020 at single dose for COVID prevention.  The patient had no medical history.  There were no concomitant medications.  The patient got his first dose of the COVID Vaccine on 18Dec2020, and he states that he did fine and had no problems. But on 28Dec2020, when he was going to work, he noticed that he had like a head cold and cold like symptoms. He was swabbed and tested for COVID PCR on that day, and he tested positive for COVID. After his positive COVID test, he was tested for monoclonal antibodies, and at first, he was told that test came back positive, but then about 12 hours later, he was told that the staff had misread it, and he was actually negative for monoclonal antibodies, so the caller was given monoclonal antibody therapy and he did fine with that, and he is recovered now. He is scheduled to go back to work this Thursday, and he is supposed to receive the second dose of the vaccine, on Friday. He checked the schedule for getting the second dose, and he was not on the list, so he called the infection control nurse, and she told the caller that because he received the monoclonal antibody therapy, he now has to wait 90 days to receive the second dose of the vaccine. Caller states that he looked for that information, and he did not see that anywhere, so he is wondering if that is correct, because it almost seems to him that if he waits 90 days, he would have to start the series again. The outcome of the event was recovered on an unspecified date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
brain zaps (internal sensation of small shocks in head) began ~18-20h after my Moderna booster, just as they began ~18-20h after dose 2 in my original series (Pfizer).  In dose 2 case, brain zaps subsided within ~6h. Waiting for same here.  Intriguingly, this symptom is one that I had rarely if ever experienced since getting it often when quitting wellbutrin ~17-20 years ago.
Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 16-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 16-Apr-2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, vaccine placed in refigerator on 04-Apr-2022, vaccine administered on 16-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, However the vaccine expired on 01-Apr-2022. The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo temperature excursion.  No treatment medication was provided.
Shingles.  Varicella-Zoster isolated by culture. Treated with acyclovir 200 mg Qid x 7 days.
Patient came for her booster dose and received a dose from a Pfizer pediatric vial. Patient received 0.3mL from pediatric vial, which would be 15mcg instead of the 30mcg.
Child got 6 month shots and had fever to 101 and a generalized rash with fussy.
Flu-like symptoms started about 12 hours later. Fever, chills, aching joints, intestinal pains, cough. Conditions have persisted for 14 hours with some lessening of symptoms in the last two hours.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 36 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Patient was seated waiting after the immunization, became light headed, fainted. Her friend caught her and alerted the pharmacy.  Pharmacist applied a cold pack to the back of the neck, checked pulse/signs of breathing/anaphylaxis.  No signs of anaphylaxis. Patient became conscious after 1-2 minutes. Ambulance was called and she was taken to hospital.  Patients friend later contacted pharmacy to let us know she was doing well.
Pt presented with large, raised hematoma on right arm (approximately equal to 3" diameter), deep purple in color.
broke out in one pock (pox) on her buttocks  / in another pock (pox) on her abdomen; has cold sores on her lips; This case was reported by a consumer via call center representative and described the occurrence of smallpox in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th March 2021, between 3 and 5 months after receiving Shingrix, the patient experienced cold sores lip. On an unknown date, the patient experienced smallpox (serious criteria GSK medically significant). On an unknown date, the outcome of the smallpox and cold sores lip were not recovered/not resolved.   The reporter considered the smallpox and cold sores lip to be related to Shingrix.  Additional details were reported as follows: This case was reorted by patient herself About a week later after receiving Shingrix, she broke out in one pock (pox) on her buttocks that cleared up after about a week. An unknown amount of time passed, and she broke out in another pock (pox) on her abdomen. This also cleared up in an unknown amount of time.  The patient stated that she noticed on the day of reporting that she has another pock on her buttocks and has cold sores on her lips. Lot number and expiry date were unknown. The reporter did not consent to follow-up.
92 years-old male had pain for 2 days; This is a spontaneous report from a contactable consumer via medical information team. A 92-years-old male patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported, a 92 years-old male had pain for 2 days. The outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
6PM 20SEP96 exp itching w/red welts starting on bilat thigh extending down legs;minimal welts & abd w/addtl welts & bilat arms;no recollection of ingestion of new foods or medication;took cold shower 10PM;when awoke 21SEP96 AM no welts;
Pt C/o feeling light headed.  V/S BP,112/74, Temp 98.0, RR14, HR95, Psox 99% RA . Pt was A&O x 4 and verbal. She was advised to stay for further observation lying. down on a cot. She was offered  125 mls of apple juice and she finished it. At 1:p m  Pt. said she felt okay  and well enough to leave. She left the site unassisted to her residence.
pain in her left hip; pain in her thigh; muscle pain in her left hip and leg; left knee and lower left leg became numb; pain in her upper back; fall twice; This non-serious case was reported by a consumer via call center representative and described the occurrence of upper back pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On 04-MAR-2023, 1 days after receiving Shingrix, the patient experienced upper back pain (Verbatim: pain in her upper back). On 05-MAR-2023, the patient experienced muscle pain (Verbatim: muscle pain in her left hip and leg) and numbness of lower extremities (Verbatim: left knee and lower left leg became numb). In MAR-2023, the patient experienced fall (Verbatim: fall twice). On an unknown date, the patient experienced pain in hip (Verbatim: pain in her left hip) and pain in thigh (Verbatim: pain in her thigh). In MAY-2023, the outcome of the numbness of lower extremities was resolved. The outcome of the upper back pain, muscle pain, pain in hip and pain in thigh were not resolved and the outcome of the fall was not reported.   It was unknown if the reporter considered the upper back pain, muscle pain, numbness of lower extremities, fall, pain in hip and pain in thigh to be related to Shingrix.     It was unknown if the company considered the upper back pain, muscle pain, numbness of lower extremities, fall, pain in hip and pain in thigh to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-AUG-2023 The patient received her 1st Shingrix vaccine and 24 hours after she had pain in her upper back. 48 hours after receiving her Shingrix vaccine she developed severe muscle pain in her left hip and leg and her left knee and lower left leg became numb. The numbness caused her to fall twice.  The numbness in her left leg resolved after 2 and half months.  The patient still (at the time of reporting) had pain in her left hip and thigh and upper back. The reporter did not consent to follow-up.
soreness at injection site; muscle aches; chills; sore throat; light headedness; heart palpitations; stuffy nose; cold like symptoms; This is a spontaneous report from a non-contactable other healthcare professional (HCP).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 16Dec2020 at 12:00 at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. The patient had no relevant medical history. Concomitant medications were not reported. On 18Dec2020 at 03:00, the patient experienced soreness at injection site, muscle aches, chills, sore throat, light headedness, heart palpitations, stuffy nose and cold like symptoms. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and loratadine/pseudoephedrine hydrochloride (THERA FLU). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient had not recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 12NOV96 noticed redness that noc;14NOV96 w/ 2cm induration @ site of inj & surrounding redness & edema of 3x9cm;itching; tx w/med;
Initial literature report received on 19 Oct 2010: This patient with no prior history of thyroid disease or symptoms to suggest a recent viral infection had received H1N1 (manufacturer unknown, batch number: unknown) on unspecified date. 1 month after vaccination the patient presented with acute onset of palpitations, anxiety, and anterior neck pain. She had clinical features of thyrotoxicosis, including sinus tachycardia and a fine tremor of both hands in addition to an exquisitely tender and enlarged thyroid gland. Serum thyroid function tests confirmed severe thyrotoxicosis with thyroid stimulating hormone (TSH)<0.02 mlU/l (reference range: 0.3-4.5 mlU/l), T4 100 pmol/l (reference 1-21 pmol/l), and T3 20.6 pmol/l (reference range 2.8-6.1 pmol/l). In the context of no recent iodine exposure, 99m Tc-pertechnetate thyroid scintigraphy was performed which demonstrated marker diffuse reduction in tracer uptake. This appearance was typical of thyroiditis. The inflammatory markers, erythrocyte sedimentation rate and C-reactive protein (CRP), were significantly elevated at 104mm/h (reference range 0-12 mm/h) and 101 mg/l (reference range<5 mg/l), respectively. Consequently the diagnosis of subacute thyroiditis, also known as De Quervain's thyroiditis, was made. 5 weeks prior to this diagnosis the patient was euthyroid with TSH of 0.55 mlU/l (reference range 0.3-4.5 mlU/l). The patient was treated with propanolol and a prolonged course of prednisone, initially at a daily dosage of 40 mg. This was weaned over several weeks and there was a gradual improvement in serial thyroid function tests after commencement of prednisone, there was a remission of her thyroiditis with following results (TSH 2.79 mlU/l, T4 12.3 pmol/l, T3 3.2 pmol/l, CRP 2 mg/l). At the time of reporting there was no evidence of the development of hypothyroidism. Seeing the temporal sequence of events, a causal link between the H1N1 vaccine and the development of patient's subacute thyroiditis was suspected.
Patient had redness and swelling at the site of injection which self resolved over 4-5 days. Noted significant pain.
fever; chills; headache; sore arm; swollen lymph node; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph node".   Additional information: It was unknown that if the patient had other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received vaccine on 12/18/09, said on 12/21/09 her voice was hoarse, ran high fever/chills/body aches and trouble breathing. Pt called pharmacy on 12/26/09 to report as Adv. rxn.
Hospitalized (11.1.21 - 11.8.21);  COVID-19 positive (11.1.21); fully vaccinated  Admission Date: 11/1/2021 Discharge Date: 11/08/2021 CHIEF COMPLAINT:  COVID HISTORY OF PRESENT ILLNESS: Patient is a 91 y.o. male with a past medical history of COPD on 6L baseline, HTN, DM type II, CKD, PVD who presents today with shortness of breath. Patient states that he woke up at 5am with shortness of breath. He checked his oxygenation and was oxygenating at 85%. He states that he had chest pain located at the center of his chest. He states the pain did not radiating to his arms or jaw. He increased his oxygen to 8L and his shortness of breath and chest pain improved. His chest pain resolved with improved oxygenation. He endorses associated chills, but denied any fever or worsening cough. He received two COVID vaccines. He presented to the hospital at the instruction of his home nurse.  Patient endorsed right lower extremity pain. He has chronic wounds and recently underwent stenting In the ED, patient was tachycardic. He originally was oxygenating well on home 6L, but later required venturi mask with 8L oxygen. He was found to be COVID positive. He underwent CTA that was negative for PE. Patient had elevated troponin first 55, repeat 73. Cardiology saw patient and thought it was likely demand ischemia and no need for additional intervention. Patient was admitted for medicine for additional management.    ASSESSMENT / PLAN: Patient is a 91 y.o. with a PMH of COPD, HTN, PVD, DM type II, CKD who was admitted on 11/1 with COVID-19 pneumonia. COVID pneumonia Baseline 6L, requiring 8L venturi on exam. Will treat with dexamethasone and remdesivir due to high risk of decompensation.  Plan: - dexamethasone 6 mg daily - remdesivir - daily CBC and CMP - oxygen to maintain sats 88-92% - continuous pulse ox Elevated troponin:  Troponin 55, repeat 73 on admission. EKG with no ST changes. Likely demand ischemia due to poor oxygenation.   - repeat troponin Progress Note 11.8.21:  DISCHARGED  DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 91 y.o. male who presented with increased SOB  found to be COVID 19 positive on date 11/1/21. CXR showed bibasilar opacities in LLL. He was treated with decadron, full course of remdesivir and diuresed with Lasix. He did require increased oxygen from his home requirements of 6L up to 12L venturi mask. Additionally, blood cultures were 1/2 positive for strep mitis/strep oralis. He was managed with IV abx and transitioned to augmentin prior to discharge. With diuresis and treatment, he improved both clinically and in lab findings. They were discharged home in stable condition back to his baseline of 6L to complete decadron course and antibiotic regimen Outcome Summary: VSS on 6L NC. D/c instructions and wound supplies sent with patient. D/c today. Pt. picked up by niece and left with home O2.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VAQTA (lot number, expiration date, dose and route were unknown). The vaccines were exposed to 30.2 F for an unspecified amount of time. No adverse effects were reported. No PQC was involved. This is one of several reports received from the same reporter. Additional information has been requested.
several pts recvd 3 doses of Engerix-B & had severe nausea, vomiting, vertigo (dizziness), extreme fatigue;
Cellulitis upper right arm approximately 10cm down arm from high deltoid area-erythema, induration.  Saw local MD 02/25/04-who said it was an allergic reaction.
Headache, extreme fatigue, sore left arm, redness/heat at injection site; lasted a couple of days
tired, nauseated, bone cold chills, pain in lungs, headache, soreness in entire arm that was injected, knot of injection, armpit swollen and sore to touch, anxiety and panic attacks, chest heavy, dizzy, hyperventilate, blood pressure extremely high, entire body sweats, flushed, fever, migraine  Symptoms started 8/23/2021 and still ongoing as of 9/22/2021
Soreness of left arm; Fatigue; Headaches; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm), FATIGUE (Fatigue), HEADACHE (Headaches), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bladder cancer. Concurrent medical conditions included Immunocompromised, Bladder disorder and Kidney disorder. Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TOPIRAMATE (TOPAMAX) and EZETIMIBE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm), FATIGUE (Fatigue), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of left arm), FATIGUE (Fatigue), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included water pill and bacterial pill for bladder.
Headache, Vaccine administration site rash and Left upper extremity/Axilla, Lymph nodes tenderness, and adenopathy
sick with temperature over 100 degrees for four days; sick with temperature over 100 degrees for four days; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, 2 weeks after vaccination, the patient was sick with temperature over 100 degrees for four days. The patient underwent lab test which included body temperature over 100 degrees for four days on an unspecified date. 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.
Temperature 103.6, headache, muscle stiffness.  Symptoms occurred 3-5 hours after vaccine.  Patient self medicated with Ibuprofen.  Doctor visit required.  Doctor advised TYLENOL 500mg two tabs every four hours as occasion requires for fever.
A report has been received from a pharmacist concerning a child of unknown gender. The patient's medical history and concomitant medications were not reported. Patient received FLUMIST QUADRIVALENT (intranasal) on an unknown date. It was reported that all the medication came out, past flu season while giving FLUMIST QUADRIVALENT to the child, because the child was laughing and moving the head forward. The outcome of the event of all the medicine came out was unknown. The reporter considered the events to be non-serious.
PATIENT RECEIVED FIRST DOSE MODERNA  VACCINE AFTER FEW MINUTES SHE IS FAINTED AND FELT ON FLOOR AT PHARMACY WAITING ROOM.PATIENT PASSED OUT FOR FEW  SECONDS. STORE ASSOCIATE CALLED 911. EMERGENCY TEAM ARRIVED AND CHECK HER VITAL SIGNS. HER BLOOD PRESSURE DROPPED TO UNDER 100. PATIENT HAD SOME SNACKS AND DRUNK GATORATE . AFTER FEW MINUTES PATIENT WAS BACK TO NORMAL SHE WAITED FOR ANOTHER 30 MINUTES AND WALKED HOME WITH MOM.