chrisvoncsefalvay/vaers-outcomes huggingface dataset:
took the COVID test and it was positive; Did not get second dose after 36 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (took the COVID test and it was positive) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon operation. Previously administered products included for an unreported indication: VARICELLA ZOSTER VACCINE in April 2021. Concurrent medical conditions included Diabetes, Gastritis, Vertigo, Depression and Thyroid disorder.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (took the COVID test and it was positive) (seriousness criterion hospitalization). On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose after 36 days). The patient was hospitalized on 22-Mar-2021 due to COVID-19. On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second dose after 36 days) had resolved. At the time of the report, COVID-19 (took the COVID test and it was positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unknown medications for diabetes, gastritis, vertigo, depression and thyroid disorder.  No treatment information was provided.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 with lot # 006B21A with an associated AE. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 with lot # 006B21A with an associated AE. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received; More than 35 days since 1st dose received/1st dose received in Feb,2021; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since 1st dose received/1st dose received in Feb,2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 16-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since 1st dose received/1st dose received in Feb,2021). On 16-Nov-2021, ACCIDENTAL UNDERDOSE (Patient received 0.25mL dose for their 2nd dose/Patient did not receive full 2nd dose of 0.5mL/Full 2nd dose not yet received) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days since 1st dose received/1st dose received in Feb,2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter declined to provide concomitant medication  and patient information details.  Treatment medication was not provided by the reporter.
Extreme tenderness in left arm, headache the night and day after the vaccine, 2inch by 2inch rash by vaccine site one week later, swollen lymph node in left armpit noticed one week after vaccine.
10 minutes after receiving the shot I had hot tingling, nausea and feeling very dizzy just like with first shot.Lasted 5minutes then I waited 20 more minutes to make sure I was ok
blood pressure was 180/73; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE SYSTOLIC INCREASED (blood pressure was 180/73) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ANASTROZOLE and HYDRALAZINE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE SYSTOLIC INCREASED (blood pressure was 180/73). At the time of the report, BLOOD PRESSURE SYSTOLIC INCREASED (blood pressure was 180/73) had resolved.            The patient reported that the reason her blood pressure had raised so high was a medication that she was recently put on around the time of the vaccination series, Anastrozole 1MG. Her physician prescribed her Hydralazine 50MG and her blood pressure was back to normal range.    NO treatment medication information provided.   This case was linked to MOD-2021-021868, MOD-2021-021868 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Concomitant medication added in the products tab. Event outcome updated.
swollen lymph nodes; Sore arm; fever; chills; sweats; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date: unknown, at the age of 54 years), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jan2021 14:30 as dose 1, single for covid-19 immunisation. Medical history included fibromyalgia, depression, and food allergy to hard shellfish. Concomitant medication(s) included tramadol; modafinil and ibuprofen and migraine med. The patient previously took lamotrigine and z-pak and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Covid was not tested prior to or post vaccination. The patient experienced sore arm, fever, chills, sweats, fatigue, and swollen lymph nodes on 07Feb2021 17:15. No treatment was given to the patient. The outcome of the events was recovered on an unspecified date in 2021.     Follow-up attempts completed. No further information expected.
Diognosed: Parsonage_Turner Syndrome (Brachial Plexus Neuritis) 100% loss of left biceps muscle and partial loss of deltoid muscle. Symptoms started within 3 weeks of vaccination of pneumococcal vaccines (G0009) and (90732).  6/29/07 Received provider medical records which reveal patient was new to practice as of 1/31/07 initial eval & showed patient in excellent health.  Initially declined pneumo vax then accepted on 2/5/07.  Vax record confirms lot & dose as reported. 7/20/07 Received neurologist medical records which reveal patient initially seen 4/13/07 for complaints of left arm, shoulder & neck  weakness & pain for approx 1 mo.  Patient had noted snapping sensation in left shoulder during work out at gym shortly prior to pain initiation.  Seen by neurosurgeon, MRI done & routine every 2 wks chiropractic treatement was done.  Following chiropractic adjustment, patient felt intensified pain w/paresthesias & weakness of left biceps muscle.  Seen by second chiropractor.  Left arm pain was quite severe over 7-10 days then subsided w/persistent weakness & tingling & left hand weakness.  Neuro exam revealed muscle wasting of left arm, esp biceps; triceps were WNL.   FINAL DX: Brachial plexus neuritis.
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot # L038018 with expiration date 13-SEP-2017, lot # L048848 with expiration date 09-AUG-2018, lot # reported as M00442 with expiration date 31-MAR-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006679: US-009507513-1707USA006675: US-009507513-1707USA006676:
This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (coughing clear flehm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (coughing clear flehm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose), NASAL CONGESTION (congestion) and PRODUCTIVE COUGH (coughing clear flehm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.
Per Dr. 1.Did the patient have an immediate allergic reaction of any severity such as urticaria, angioedema, respiratory distress, or anaphylaxis (<4 hours following administration of the COVID vaccine)? Yes. 2, Did the patient previously have an immediate allergic reaction of any severity to polysorbate or polyethylene glycol? No. 3, Has the patient had prior anaphylactic reactions from another vaccine, medication or any other cause?  Yes. 4, Did the patient have an allergic reaction >4 hours after administration? OR have an expected side effect of the COVID vaccine? No. Pt received COVID vaccine, Pfizer 1st dose. Approximate 5 minutes in the observation area pt complained of headache, throat discomfort, and stomach upset. She has a history of food additive allergy (dough additive), has an epi pen but has never needed to use it per mother at bedside. Initial VS: T 98.2 P 84 BP 119/70 RR 20 SpO2 99% on room air. She was monitored in the adverse reactions area. She was given Benadryl 25 mg oral x 2, and cetirizine 10 mg oral x 1. During observation period she had observed worsening oropharynx swelling, and stridor/inspiratory wheezing. VS prior to transfer was P 78 BP 102/69 RR 18 SpO2 100% on room air. EMS was called and pt transferred to ER for further monitoring, Tryptase level, and epinephrine if needed. Pt was recommended to see her pediatrician or allergist to discuss 2nd dose options prior to scheduling appointment. Signed: DO, 5/21/2021 2:59 PM".
This spontaneous report as received from a pharmacist who received the following information from a nurse, refers to a 57 years old female patient with high blood pressure, hypothyroidism, mood disorder, depression and anxiety. The patient had no reported allergies. The patient was vaccinated subcutaneously with PNEUMOVAX 23 on 08-DEC-2012 (dose not reported) (lot # H014282, exp date 09-APR-2014). No other co-suspects were reported. Concomitant medications included LEVOXYL, thiamine, trazodone hydrochloride, EFFEXOR XR, FLUVIRIN, folic acid, LOPRESSOR, multivitamins (unspecified) and PRILOSEC. On 09-DEC-2012 the patient developed swelling, pain and suspected cellulitis in the arm where the injection was received. The patient was given cephalexin (manufacturer unspecified). The patient had not recovered yet. A lot check was requested. The pharmacist also reported that the nurse practitioner told her that 2 additional patients (demographics unspecified) also had swelling, pain and suspected cellulitis after receiving PNEUMOVAX 23 in the past. It was unspecified what lot of PNEUMOVAX 23 this 2 patients received. It was unspecified what date PNEUMOVAX 23 was received in these 2 patients. All other information of this 2 patient was unspecified (case # 1212USA005279). The relationship between swelling, pain and suspected cellulitis in the arm where the injection was received and PNEUMOVAX 23 was unknown. Additional information has been requested.
this pharmacy did not give a sticker as previous vaccines with lot # just an RX number.  All my previous vaccines were on my Left arm last 9/17/2022 I had swelling for 2 weeks. I decided to use right arm for this vaccine. No swelling but on 10/13 started to have bleeding (spotting only)  similar to a light menses. I had Covid in 2020 and had same symptom.
pt recvd vax & t 105; pt was fretfull & jittery for whole day;
pt recvd vax; local rxn at inject site;induration approx 12cm in diam; area red, tender & hard; afebrile; to MD & tx w/ dph,pred & atbs;dx: vax rxn
About 1 mo after getting vaccination broke out with raised lesions that turned purple - took to specialist DX with Henoch-Schonlein purpura. Not sure if it was related to flu vaccine or not but PMD told mom no more vaccination. No meds were given to tx purpura.
Burning uterine pain; Burning uterine pain; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 12:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 16:45, the patient experienced burning uterine pain. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event burning uterine pain was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Swollen, red and firm at site of injection. Tender to touch. Developed  low-grade fevers, body aches, as well as headaches in the evening and into the following day.
6 y/o presented for COVID-19 vaccine. Adult formulation of Pfizer Covid-19 vaccine diluted in error with 1.3 cc of diluent and 0.2 cc administered to 6 y/o via IM injection in left deltoid. Error realized soon after child left clinic. Parent notified. Instructed to monitor for adverse events. 12/18/2021-F/U by phone, no problems reported.
Patient reported being covered in hives from neck down, numbness in her face that lasted 5 minutes, and numbness in collarbone.  These reactions started about 2 and 1/2 hours after getting her vaccine.  The clinic was over and the manager of the facility called me to report that her employee reported this to her and she gave her a Claritin.  Her symptoms greatly improved and hives did start to go down after taking the Claritin dosage. The numbness has resolved.
I tested positive for COVID-19 on 3/12/23. I had congestion, body aches, and a low-grade fever. I contacted my doctor and was prescribed Paxlovid. I felt better in a few days. It was a very mild case.
Within a few minutes after Jannsen vaccination, in the observation area, patient called attention to staff. A few nurses arrived immediately including this RN. She became dizzy, nauseated. Emesis bag but no vomiting occurred. Vital Signs taken with Systolic BP in the 60's, mild bradycardia, significant clamminess. Patient endorses usally HR higher than this. Patient then developed a period of absence x 2, similar to absent seizure. Patient was laid on a stretcher with slow improvement in S-BP to 111 and clamminess. Given the significant hypotension and suspected absence seizures, staff had already call 911. Patient reported only having some popcorn and coffee all day with no meaningful intake of food or fluids once patient became more alert. This RN provided 2 bags of chips with salt and 2-16 oz. bottles of water. This RN encouraged intake. Fire, EMS, and Police arrived. Patient refused transport to hospital. Patient agreed to wait until significant other arrived to drive patient home. Patient stayed for about an hour extra to eat and drink with moderate effect. Patient stood up and felt moderately dizzy but patient was able to ambulate to her significant other's vehicle. The team encourage patient to contact and see PCP regarding the absent seizure and encourage rest with hydration and intake at home. Incident report was filed with facility.
Pain in arm at injection site, low grade fever, headache, muscle aches, rash (similar to sunburn) which began at top of left arm and spread down upper arm to just below left elbow, dizziness seven days after vaccination
This spontaneous report as received from a medical assistant, refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical  history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (of lot # L035880. expiry date: 11-AUG-2018; dose 0.5 ml, subcutaneously). Concomitant medication was not mentioned. The reporter further informed that the vaccine was exposed to a temperature of 47F for 20 hours. No adverse effects were reported. No further information was available. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter.
Light-headedness a few hours after the shot. Injection site (deltoid of left arm) went stiff, slightly weak. High fever developed and stayed for four days. Shoulder pain worsened so much that I awoke moaning in pain multiple times in the night. Slowly regained use of arm (being able to lift arm), but I had limited arm mobility and pain for five weeks. Oddly, no injection site marks, redness, visible swelling. Although unable to lift arm, I never lost use of hand.  I held off on reporting symptoms because I did not want to encourage vaccine skepticism, but at this point, I'm just going to be honest.
Initial and follow-up information have been received from a physician concerning an 83 year old female with drug allergy to bisphosphonates and a history of intolerance to alendronate sodium (MSD, WAES 1007USA02286), and no other medical history who on the evening of 12-JUL-2010 was vaccinated subcutaneously into the left arm with a standard dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included simvastatin (manufacture unknown), vitamins (unspecified), aspirin, senna and glucosamine. The patient was not recently exposed to shingles. On 13-JUL-2010 (also reported as 15-JUL-2010, 24 hours since vaccine exposure) the patient experienced shingles like rash on her right temple, forehead and right side of face. It was described as a "burning rash". The rash did not occur at the injection site. The physician also reported that the rash type was varicella and was distributed on the right cheek and forehead with less than 20 of lesions. Maximum temperature was 97.8 F. The patient refused to provide any specimen. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information has been requested.
Received shots, PPD.  Approximately 10 minutes later, passed out briefly.  Was in seated position, no fall.  Admitted he had not eaten on this AM
fever, fatigue Narrative: Patient took Tylenol and felt better within 48 hours.
FEET HURTING; FEELS SO WEAK; HURTING HEAD; HEART HURTING; CHEST HURTING; FEET SWOLLEN; DIZZY; This spontaneous report received from a patient concerned a female of unspecified age with unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included STD (sexually transmitted disease), and non-alcoholic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805021, and expiry: UNKNOWN) dose was not reported, administered frequency one total on 26-MAY-2021 11:48 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021 (also stated as 2 days ago) patient reported chest was hurting, heart was hurting, feet swollen, head hurts, and feels weak. On an unspecified date the patient experienced feet hurting. It was also mentioned that the patient was currently still experiencing these side effects (dates unspecified). It was stated that the patient took a heart pill. Patient was unable to identify what kind of heart pill she was taking. On an unspecified date in 2021, the patient experienced dizzy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest hurting, heart hurting, feet swollen, hurting head, and feels so weak, and the outcome of dizzy, and feet hurting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: -covid-19 vaccine ad26.cov2.s -heart hurting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt developed chest pain the next morning which continued intermittently for 2 weeks and became severe on 1/10/22 which lead to hospitalization. Pt was found to be in a tachycardic junctional rhythm and treated with adenosine.