chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was dizzy as heck when I got up; Low grade fever; Chills real bad; Weakness in my muscles; I couldn't sleep; I coughed all night long from tickle in throat; Tickle in throat; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat) and DIZZINESS (I was dizzy as heck when I got up) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L213, 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat), PYREXIA (Low grade fever) and CHILLS (Chills real bad). On 24-Dec-2021, the patient experienced DIZZINESS (I was dizzy as heck when I got up). At the time of the report, MUSCULAR WEAKNESS (Weakness in my muscles), INSOMNIA (I couldn't sleep), COUGH (I coughed all night long from tickle in throat), THROAT IRRITATION (Tickle in throat), DIZZINESS (I was dizzy as heck when I got up), PYREXIA (Low grade fever) and CHILLS (Chills real bad) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.  The patient said if he fall, then won't be able to get up. He had no side effects after second dose.   This case was linked to MOD-2021-426713 (Patient Link).
Ipol that was not suitable for use due to being involved in the temperature excursion with no AE; Initial information regarding this unsolicited valid non-serious case from the via Global Medical Information (GMI) (Reference number- 00422264) was received from Other Healthcare Professional on 08-Jan-2021.  This case involved seven patients (unknown demographic) who received dose of IPV (VERO) [IPOL] (lot number and expiration date not reported), that was not suitable for use due to being involved in the temperature excursion (product storage error). [caller did not have patient information or had the vaccine information]  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a case of actual medication error due to incorrect product storage error.  It was reported, nurse advised punctured IPOL was given to patients after temperature excursion in which they had gone out of range wanted to know if they should re-vaccinate those patients.  At the time of reporting, no adverse event was reported.  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 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.  There will be no information available on batch number for this case.
pt recv vax & felt nervous;could not sit still;felt very lost;didn't know what was doing where was going;ended up getting into a single car accident & following that roamed into a field & got lost;
pt recv vax; devel T 102-103 & scattered papular rash which progressed to 50-75 lesions;lesions were located primarily  on trunk;to MD;
MUSCLE SPASM IN THE LEG; NEUROPATHY (LEFT ARM PAIN ALONG WITH STABBING, SHOOTING, BURNING, NUMBNESS WITH DIFFICULTY IN MOVING LEFT ARM); This spontaneous report received from a consumer concerned a 58 year old  male. The patient's weight was 206 pounds and height was 76 inches. The patient was diagnosed as a teen with epilepsy (did not take medications for 5 years) and he had been seizure free. Patient was alcohol user (He consumes an occasional beer on the weekend) and non-smoker. The patient was healthy. He had no known allergies and no history of drug abuse or illicit drug use. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, with frequency time 1 total administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Omega-3 supplements (omega-3 nos). On 10-AUG-2021, the patient experienced neuropathy along with left arm pain along with stabbing, shooting, burning, numbness and difficulty in moving left arm because it felt asleep. The patient had been able to do his daily activities such as surfing, driving, playing basketball and attending his job. It was reported that patient did not quantify the pain. On 11-AUG-2021, the patient experienced muscle spasm in the leg. The patient complained of a muscle spasm similar to the arm pain, felt in his leg. It was reported that patient came home and rolled his calf out with a muscle roller, which would make it go away. The patient complained of this in the evening, as it was exacerbated by activities such as basketball.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle spasm in the leg and neuropathy (left arm pain along with stabbing, shooting, burning, numbness with difficulty in moving left arm).  This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210829160-Covid-19 vaccine ad26.cov2.s Neuropathy. 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).
Discovered that patient received second dose on 5/8 when the first dose was only given on 4/30 - therefore, there were not 21 days between doses.  medication error / no adverse drug reaction reported.
Patient received an expired dose of IPOL with no reported adverse event; Initial information received on 01-Feb-2022 regarding an unsolicited valid  non-serious case received from health professional.  This case involves a 56 years old male patient who received an expired dose of ipol with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13V (CRM197) (Prevnar 13), Hepatitis B Vaccine (HEP B VACCINE ADULT CIPLA), HIB VACCINE (HIB) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) all for Prophylactic vaccination.  On 27-Dec-2021, the patient received suspect IPV (VERO) at a dose of 0.5 ml once (lot R1S972M, expiry date: 03-Oct-2021, strength, form not reported) via unknown route in the right deltoid for immunization.  On 27-Dec-2021 the patient received an expired dose of ipol with no reported adverse event (expired product administered) same day of latency following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient received an expired dose of IPOL with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received an expired dose of ipol with no reported adverse event.     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 guidelines. 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.
Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 74 year old, female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  Patient took an antibody test as directed by health care physician on 15-SEP-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative (no antibodies). Patient also went to her heart doctor to understand the test results and he explained results to patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: Sender's Comments: V0: 20210955430-COVID-19 VACCINE AD26.COV2.S -Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Tingling lips, swollen, face swelling with hardening of skin, no breathing issue, then in AM raised maculopapular rash on forearms, facial swelling remains.
Pt experienced deep atrophy left deltoid muscle with dark brown discoloration and deep indentation (1/4 inch) scarring in the center at injection site.
FEVER; BODY ACHES; HEADACHES; JOINT PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included gastritis, and hypertension, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headaches. On 09-MAR-2021, the subject experienced joint pain. Laboratory data included: Body temperature (NR: not provided) 100.0-101 unknown unit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, headaches, and joint pain. This report was non-serious.
Acute hypoxemic respiratory failure. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Back pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Reporter did not allow further contact
Tested negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Tested negative) 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 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Tested negative). At the time of the report, ANTIBODY TEST NEGATIVE (Tested negative) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-106737 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106737:Case for husband
stomach started cramping & felt nauseated did not vomit; called 1220PM 16JUN95; still having some stomach cramping otherwise feeling okay;
Breakthrough case admission after 2 vaccines Moderna 3/23/21 Lot# 045A21A;  Moderna 4/20/21 Lot# 044B21A;
flu like symptoms chills, weakness,minor headache and body aches! from 8pm 3/15 until now about noon 3/16
dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered to the patient from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vial was initially stored in the refrigerator was on 31-Mar-2022. The vial was first punctured was on 21-Apr-2022 at 10:20 am and was stored in refrigerator post puncture. The exact administration time was not provided but it was reported that on 22-Apr-2022, the patients were received the vaccines from 9:30 am to 1:15 pm. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature (8 degree to 25 degree Celsius= 46 degree to 77 degree Fahrenheit) was unknown but it was reported that the vial did not expose to room temperature for greater than 24 hours.  The patient did not report any adverse reactions.  No treatment information was provided by the reporter.
Stabbing chest pain began morning of 9/11/21 and continued for the next week. Unrelieved by lorazepam and continued for over 14 days, eventually becoming an experience that only appears during exertion.
DTaP given 6/18 11 am.  6/20/03 site of injection red swollen and warm to touch, hyper acting
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA390652 (patient's husband). This case involves a 67-years old female patient who experienced strong cough with mucus, stuffy nose, at night couldn't sleep, headaches, chest pain and sick with a cold, while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included INFLUENZA VACCINE (Reporter stated that they always have flu vaccine and never experienced any reactions). The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date in September 2018, the patient received a single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious strong cough with mucus (productive cough), stuffy nose (nasal congestion), couldn't sleep (sleep disorder), headaches (headache), chest pain and sick with a cold (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient got really sick after a day, strong cough with mucus comes from the chest, with chest pain, stuffy nose, at night couldn't sleep along with headaches. (Other relevant tests included No lab data.) Final diagnosis was sick after a day, chest pain, headaches, at night couldn't sleep, stuffy nose and strong cough with mucus. The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) to help alleviate their symptoms. The patient outcome was reported as Unknown for all the events. List of documents held by sender- none.
Developed red area in a circle around injection. It is warm and it itches. The area is about 3 inches across. I looked at it 4 days after injection.
It's a little hard; Injection site has red spot the size of a head of a thumbtack; arm started itching; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PRURITUS (arm started itching), INDURATION (It's a little hard) and INJECTION SITE ERYTHEMA (Injection site has red spot the size of a head of a thumbtack) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy. Concurrent medical conditions included Blood pressure high, High cholesterol, Penicillin allergy, Sulfonamide allergy and Drug allergy (Levaquin allergy.). Concomitant products included BENZOYL PEROXIDE (BP), OMEPRAZOLE and LOSARTAN.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (pain). On 27-Jan-2021, the patient experienced PRURITUS (arm started itching) and INJECTION SITE ERYTHEMA (Injection site has red spot the size of a head of a thumbtack). On an unknown date, the patient experienced INDURATION (It's a little hard). At the time of the report, PAIN (pain), PRURITUS (arm started itching), INDURATION (It's a little hard) and INJECTION SITE ERYTHEMA (Injection site has red spot the size of a head of a thumbtack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
fever; aches; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2022 08:00 (Batch/Lot number: unknown) at the age of 57 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL. Vaccination history included: Covid-19 vaccine (DOSE 1,2,3; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 2022, outcome "recovering", described as "aches"; HEADACHE (non-serious) with onset 2022, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 2022, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of pyrexia, pain, headache, nausea.  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: atenolol. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Device Date : 01Apr2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness, swelling 9.5 x 7.5 erythema on rt arm with l axillary lymph node felt
Vaccine #1: 3/17/21   Vaccine #2: 4/14/21.  Went to ER morning of 7/8/21 with nausea,  dizziness, headache. Blood pressure was 186/? ( I don't remember bottom) All other tests were negative. Followed up with my doctor monthly. BP has been running high despite continued increase in medication. I'm now on 3x the metoprolol and a new medication losartin. There's no way to guarantee it was the vaccine, but BP was under control previously. It's running around 150/78 now with increased meds. Thought you should know.
Pt. was given HPV vaccine and pt. had reaction - fainted and had a very brief seizure like jerking movements for about 10 seconds. Pts. face was pale and BP decreased after episode. Glucose was checked and ok at 89. Pt was given water put in Trendelenburg posit. till he was stabilized.
Patient is a 64 year old male. Sx began day after the Tdap. Aching, myalgias, malaise, very sore arm, then a cough which he still has. No exposures, no pmh of pertussis, no rash. No is tired and has a cough. No sx with yard work. I have reviewed all pertinent lab, EKG, imaging studies and advised and discussed appropriate diet and exercise. Reaction to DTaP immunization prednisone 20 mg tablet.
Eyes rolled back in head, pt became pale, syncopal episode. Solu Medrol, Benadryl, Epinephrine  3/25/08 Reviewed ER medical records of 3/15/08. FINAL DX: dog bite leg; anaphylactic shock Records reveal patient seen s/p unprovoked attack & dog bite left leg by stray dog.  Visible bite marks on anterior left leg were cleansed & tx w/topical antibiotics & oral antibiotics x 10 days.  Also had Td, (Decavac, lot #1275). Rabies prophylaxis: infiltration of 1650 IU of human rabies immunoglobulin (HRIG) in & around wound approx 1 hour after Td.  During infiltration, became diaphoretic, pale, pupils dilated, seizure like activity for approx 30 sec.  Tx w/steroids, benadryl, epi & IV antibiotics.  Oriented immediately after reaction & VSS. No reaction at wound site.  Kept overnight for continued observation & d/c to home.
Approximately 4 hours after vaccine shot developed itch all over body.  No rash, but constant itch.  Following morning extreme headache and body ache.   On Saturday night, 1/30/21, I started to feel neurological issues.  All the nerves in my body felt like they were exploding.  Body was shaking and felt weakness in legs and arms.  This constant feeling of all my nerves running up and down the body lasted for 6 days.  I contacted both my physician and the pharmacist at Quality Care Pharmacy and reported what I was experiencing.  Both felt that my body had an extreme reaction to the first shot and thought that I probably should not get the second shot and advised against it.  I am scheduled for the second shot on 2/24/21.  Ultimately, it would be my decision, but based on my adverse reaction days after the 1st shot, I am afraid to get the 2nd one.