chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the second antibody test, three months later came back with a negative result below 1; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (the second antibody test, three months later came back with a negative result below 1) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031IL20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis since 1997, Hypothyroidism since 1980, Hypertension since 2006, Seizures since 2008, Restless legs since 2010, Penicillin allergy and Shellfish allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE [NORTRIPTYLINE HYDROCHLORIDE]) for Depression, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ESTROGENS CONJUGATED (PREMARIN) for Hysterectomy, ROPINIROLE HCL for Restless legs, TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis, LAMOTRIGINE for Seizures, EPINEPHRINE (EPIPEN), PARACETAMOL (TYLENOL), NAPROXEN SODIUM (ALEVE) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Oral) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (the second antibody test, three months later came back with a negative result below 1). At the time of the report, ANTIBODY TEST NEGATIVE (the second antibody test, three months later came back with a negative result below 1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 2.94 Positive and (Negative) below 1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Oral), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 with the event was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up information received on 01-jul-2021 contains Significant information Added concomitants Synthroid, Premarin, Lipitor, ropinirol HLC, Bystolic, XELJANZ , LAMOTRIGINE,  NORTRIPTYLINE, EPIPEN . Added treatment drugs TYLENOL, ALEVE, EXCEDRIN MIGRAINE. Added medical history Allergy to penicillin , shellfish and rheumatoid arthritis,  hypothyroid, hypertension, restless leg, seizures.
After vaccines dad said patient had cough and felt cold.  RN took patient's temp and was 97.5 ax, patient alert and talking to RN. Did not seem in any respiratory distress. Doctor came in room and listened to lungs and examined him.  Injection sites looked normal. Dad then mentioned he was worried and before patient was shaky some after vaccine.  Dr. told to monitor for 10 more minutes.  RN checked on patient 10 mins later-noticed one hive on stomach. RN took patients oxygen saturation and was 99% and heart rate was 113.  Dr. came back in to check on patient and ordered Benadryl.  Family declined benadryl.  Monitored patient for another 10 minutes.    Dr. went back to check on patient and papule was fading upon re check and had continued reassuring exam (per notes of Dr).
Clinic observation: slight diffuse induration in the deltoid area of the right arm.  Red and blotchy in the area noted.  Not hot to touch and withoug tenderness or vesicles.  Temperature was 99.6.  Mom stated she noted the reaction 2 days after the immunization was given when her daughter c/o of arm hurting.  Mom was instructed to give Benadryl exlixir per directions, prn.
Muscle pain; joint pain; mild fever; feeling unwell; chills; headache; tiredness; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 15:45 (Lot number: 301558A) at the age of 77 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Allergic Rhinitis" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "known allergies: Sulpha" (unspecified if ongoing), notes: known allergies: Sulpha. Concomitant medication(s) included: LEVOTHYROXINE; SIMVASTATIN. Past drug history included: Tetracycline, reaction(s): "allergies: Tetracycline", notes: known allergies: Tetracycline; Bactrim, reaction(s): "allergies: Bactrim", notes: known allergies: Bactrim; Belladonna, reaction(s): "allergies: Belladonna", notes: known allergies: Belladonna; Mercurochrome, reaction(s): "allergies: Mercurochrome", notes: known allergies: Mercurochrome. Vaccination history included: Flu (Vaccine location: Left arm), administration date: 12Sep2021. The following information was reported: MYALGIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "Muscle pain"; ARTHRALGIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "joint pain"; PYREXIA (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "mild fever"; MALAISE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "feeling unwell"; CHILLS (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "chills"; HEADACHE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "headache"; FATIGUE (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "tiredness"; VACCINATION SITE PAIN (non-serious) with onset 28Sep2021 11:00, outcome "recovered" (Sep2021), described as "injection site pain". Therapeutic measures were taken as a result of myalgia, arthralgia, pyrexia, malaise, chills, headache, fatigue, vaccination site pain.  Additional information: The patient was treated with Tylenol every 6 hours for events and Rest. The patient was not diagnosed with COVID-19 Prior to vaccination, and not been tested for COVID-19 Since the vaccination. Medications received within 2 weeks of vaccination were Simvastatin, Levothyroxine.  No follow-up attempts are possible. No further information is expected.
Night of with chills, sweats, for several hours the day of the second immunization 3-7-21.  Next day major flu like symptoms...then OK.
Patient was observed as acting a little lethargic. When approached, she had slurred speech and reported feeling numb. BP was taken and initially 160/100. Continued coaching correct breathing and taking BP. Within 10 mins BP dropped to 120/88. Patient was asked about trouble breathing multiple times, and always indicated that her chest was not tight and she did not have trouble breathing. Diphenhydramine 25 mg was given within the first 10 mins, but did not improve symptoms. Patient still lethargic, slurred speech, and indicated feeling numb so called 911. Patient never loss conscience.
chills; malaise; raynauds in left fingers cold,blue; tingling; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 21Dec2020 06:15PM, at right arm, at single dose for covid-19 immunization. Medical history included Guillain barre after flu vaccine in 2010, covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received flu vaccine in 2010. The patient experienced chills, malaise, raynauds in left fingers cold, blue, tingling on 22Dec2020 08:00 AM. No treatment received for all events. The outcome of events was recovering. Patient had not tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Cough, asthma, headache, fatigue, fevers, muscle and joint pain, nausea, chills, swollen lymph node
3 days after the shot I began to notice my heart acting up.  On February 27, 2021, 9:00 am, I began feeling bad and started getting dizzy.  I then began to almost pass out.  I called a nurse and was instructed to eat peanut butter and drink juice to bring my sugar up.   After  30 minutes and the coke and 2 tablespoons of peanut butter I had checked my sugar and it was only 147. I stopped taking my metformin. My testing kit was not working.  Monday I got my testing kit to working and my sugars were low to normal range.    Tuesday, March 2, 2021, 10:00 am I felt my heart racing and taking my breath away.  I was instructed to get to an ER.  I went to the hospital.  They detected Tachycardia, heart jumping over 220 b/m.  I was placed on medication and admitted.  All ICU beds were full as was Telemetry beds.  I was placed on a non-floor with heart monitor.  My sugars kept being low so I did not take my Metformin and I ate a regular diet which contained a lot of sugar to keep my levels up.  On March 4, 2021, I went into A-Fib.  They then doubled my medication.  I was discharged the next day.  Upon follow up my Dr., after reviewing all the test results stated the only explaination was my Kovid shot.
10 days, post vax, pt had a rash and right anterior cervical adenopathy.
This spontaneous report as received from a consumer refers to an approximate 54 year old female patient with systemic lupus erythematosus and sulfa drug allergy. On 10-JAN-2014, the patient was vaccinated with PNEUMOVAX23 lot # J009827, expiry date 10-AUG-2014 in the left arm. Concomitant therapies included SYNTHROID, FLUZONE (taken on 10-JAN-2014; (manufactured by Sanofi Pasteur)) and FETZIMA. On 11-JAN-2014, the patient had fever of 102 degree; lips and throat are itchy, headaches, injection site lumpy (She now has two lumps at the injection site on the left arm), hard, purple colored, sensitive to the touch of clothing, itchy, warm, and swollen and patient was dizzy. Last night she stated that the itchiness at the injection site was intense. The outcome of the events was reported as not recovered. Causality assessment was assessed as related to PNEUMOVAX23 as patient reported that the side effects, she was experiencing from PNEUMOVAX23 shot. Patient sought medical attention by seeing the physician. Product quality issue was not involved. Additional information has been requested.
Body tremors, body aches, fever of 102 oral.  upon awakening in the am, bilateral legs red (petachia), swollen and warm.  Went to urgent care center and was evaluated and no diagnosis.  No treatment or medication.  Sent home.  Told to report to facility that gave vaccine.
Blisters in mouth and throat; swelling on face; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters in mouth and throat) and SWELLING FACE (swelling on face) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 01-Mar-2021, the patient experienced BLISTER (Blisters in mouth and throat) and SWELLING FACE (swelling on face). At the time of the report, BLISTER (Blisters in mouth and throat) and SWELLING FACE (swelling on face) outcome was unknown.      Patient stated that she takes many medications but could not provide details of them. No treatment information was provided.
blood clotting.; pain in right leg and knee; pain in right leg and knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clotting.) in a 66-year-old female 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.     Concurrent medical conditions included ADHD, Anxiety, Inflammatory arthritis and Blood pressure high. Concomitant products included ATOMOXETINE HYDROCHLORIDE (STRATTERA) for Anxiety, SULFASALAZINE for Arthritis, PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure high, PREDNISONE for Inflammatory arthritis.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee). On 11-Jun-2021, the patient experienced THROMBOSIS (blood clotting.) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clotting.), PAIN IN EXTREMITY (pain in right leg and knee) and ARTHRALGIA (pain in right leg and knee) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient visited ER due to pain the leg and knee and was diagnosed with blood clotting.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added Reporter information(address, contact details), patient demographic information, medical history. Added vaccine batch number, route of administration, concomitant medication information. Start dates of the events pain in extremity and arthralgia added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Whole arm went numb and paralyzed immediately. Recovered slowly within 2 hours.  By 6 PM was coughing and sore throat.
RN has erroneously given flu vaccine IV instead of IM. Patient's breathing slowed down-- > became apneic.  Telemetry applied -  flat line.  No spontaneous breathing.  No pulse or heart beat.  Pupils dilated.  Suspected PE. Time of death 10:35 am
Lip swelling/tingling without airway compromise, full body itching, Covid symptoms. Lasted approx 48hours, took 50 mg benadryl every 4 hours and pepcid twice a day for 5 days
INTENSIFIED BODY ACHES; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included coconut allergy, alcohol user, and non-smoker. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042a21a, expiry: 21-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced intensified body aches. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, intensified body aches, and nausea. This report was non-serious.
Patient state experience rash and pain on from hip to pelvic area.  Patient state she visited her physician and the doctor put her on Acyclovir 1 gram three times daily to treat the symptoms.
Information has been received from a physician concerning a 92 year old female who in approximately 1978 (at age 65) was vaccinated with Pneumococcal 23v polysaccharide vaccine (pneumococcal 23v polysaccharide vaccine was approved Jul 07 1983). On Dec 20 2005, the patient contracted pneumonia and was hospitalized. Chest x ray and unspecified labs indicated that streptococcal pneumoniae may be involved. The patients pneumonia was reported as not recovered. Pneumonia was considered to be immediately life threatening. No further information is available.
stomach cramps, vomitting, lower abd pain, extreme body temp changes, vision changes, was "seeing things, squirrels and mice to be specific",  INR was "out of whack", blood was too thin, numerous bruising. Was seeing and hearing things no one else was
Patient reported fever, itching, redness, and a sore left arm that occurred 4 hours post AFLURIA and PNEUMOVAX 23 vaccination. The patient stated that he was in bed for 1 and 1/2 days and the arm soreness lasted at least 2 weeks. He said that he took Ibuprofen 200 mg tabs every 6 hours and is now feeling better.
Hard lump at site of injection; Swelling, redness and pain at injection site; Swelling, redness and pain at injection site; Swelling, redness and pain at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling, redness and pain at injection site), VACCINATION SITE ERYTHEMA (Swelling, redness and pain at injection site), VACCINATION SITE PAIN (Swelling, redness and pain at injection site) and VACCINATION SITE MASS (Hard lump at site of injection) in a 29-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023, the patient experienced VACCINATION SITE SWELLING (Swelling, redness and pain at injection site), VACCINATION SITE ERYTHEMA (Swelling, redness and pain at injection site) and VACCINATION SITE PAIN (Swelling, redness and pain at injection site). On an unknown date, the patient experienced VACCINATION SITE MASS (Hard lump at site of injection). In October 2023, VACCINATION SITE SWELLING (Swelling, redness and pain at injection site), VACCINATION SITE ERYTHEMA (Swelling, redness and pain at injection site) and VACCINATION SITE PAIN (Swelling, redness and pain at injection site) had resolved. At the time of the report, VACCINATION SITE MASS (Hard lump at site of injection) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, patient had swelling, redness and pain at injection site lasting 3 days and had hard lump at site of injection.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Left arm pain/redness/swelling starting 2 days after vaccine given. Redness & swelling resolved but pain has persisted.
Sx: sore at injection site on day of shot. Felt fine next day, then on third day, began sx deep, aching pain shoulder, arm down to elbow jt and wrist, disturbs sleep (worse at nite to am), good ROM. Pain relieved with 400mg Ibuprofen. Comes in waves, constant since onset to at least 10/3/02. Sings: no induration, abscess, tenderness on arm, no rash, no fever. Recovered. 10/4/02.
Local redness and swelling around site. Concern caused mom to seek treatment from local clinic on Sunday
my arm started hurting where shot was, then whole arm started hurting, then I could not lift it; muscle pain; could not sleep at all last night; I have the chills; itch; I am in pain, ache all over; nausea; dizziness; weakness; tiredness; headache; feeling unwell; sore throat; 101.4 F temperature; This is a spontaneous report from a contactable consumer or other non hcp.   A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0153), dose 1 via an unspecified route of administration on 14Apr2021 as DOSE 1 SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  On 14Apr2021, the patient stated that I got the first dose of the Pfizer Covid 19 vaccine yesterday,. Later one in the day, my arm started hurting where shot was, then whole arm started hurting, then I could not lift it, could not sleep at all last night, very excruciating.  I have the chills, I itch, I am in pain, ache all over, nausea, dizziness, weakness, tiredness, headache, muscle pain, chills, fever, feeling unwell, and sore throat. No additional details provided.  She declined transfer to Safety but consented to further follow-up from Safety. The patient underwent lab tests and procedures which included 101.4 F temperature on an unknown date. The outcome of all events was an unknown
dry vomiting; GFR had been 18 but drop to 7; This is a spontaneous report from a contactable consumer (patient) reported in response to consumer letter sent via follow-up letter. A 67-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in arm on 11Mar2021 (Batch/Lot Number: EN6208) as 2nd dose, single for covid-19 immunisation. Medical history included polycystic kidney disease genetic from mother, stage 4 kidney failure. Family medical history included mother had polycystic kidney disorder. Concomitant drug was none. Prior vaccination (within 4 weeks) was none. Patient previously received first dose of BNT162B2 on 18Feb2021 16:00 (Batch/Lot no: EN6201) via intramuscular in arm for covid-19 immunisation and experienced sick for basically 2 weeks. The patient experienced dry vomiting and GFR had been 18 but drop to 7 (both seriousness criteria: hospitalization) on 12Mar2021 02:00. Adverse events required visit to emergency room. Duration of stay in hospital was 11 days. Treatment received including haemodialysis. Patient stated had a very difficult reaction to the first shot, sick for basically 2 weeks. Hesitated to take the second shot. Could find no information on people with kidney disease. All doctors said get the shot. Patient did and 10 hours later. Patient was dry vomiting uncontrollably went to the emergency room. Patient's kidney GFR had been 18 but dropped to 7 after the shot. Patient was put on emergency now permanent haemodialysis was in hospital for 11 days. Dialysis was in patient's future but not so soon. As an aside last night. Patient was talking to neighbour her sister worked in a nursing home. After 2 period of no COVID deaths 6 patients died of kidney failure after taking vaccine. Relevant tests was none (as reported). Vaccine was not administered at Military Facility. Conclusion stated more research needed on people with advanced kidney disease. The event outcome for events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.