chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; not feeling well; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MALAISE (not feeling well) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced ASTHENIA (weakness), MALAISE (not feeling well) and FATIGUE (fatigue). On 28-Mar-2021, ASTHENIA (weakness), MALAISE (not feeling well) and FATIGUE (fatigue) had resolved.            No medical history was provided by the reporter. No concomitant medications reported by investigator   This case was linked to MOD-2021-040701 (Patient Link).
Headache, Sedation, Myalgia, Arthralgia, "hangover" Narrative: "legs have felt strange" leg spasms
Bruise at injection site with large, round area that is swollen and tender to touch after day 8. Today, still with injections site bruise and swollen, painful area below injection site that feels like pin pricks when touching it.
gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.; sick for awhile after first vaccine; cancelling second vaccine.First Vaccine given on 03MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS (gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.), ILLNESS (sick for awhile after first vaccine) and PRODUCT DOSE OMISSION IN ERROR (cancelling second vaccine.First Vaccine given on 03MAR2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis, Gastric disorder (Patient has a medical history with trouble with her belly, related to her with Esophagus and Gall Bladder) and Diabetes.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS (gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.), ILLNESS (sick for awhile after first vaccine) and PRODUCT DOSE OMISSION IN ERROR (cancelling second vaccine.First Vaccine given on 03MAR2021). At the time of the report, GASTROENTERITIS (gastro issue is sporadic but this time she has been sick for awhile, after the first vaccine.), ILLNESS (sick for awhile after first vaccine) and PRODUCT DOSE OMISSION IN ERROR (cancelling second vaccine.First Vaccine given on 03MAR2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter.  Treatment details not included.
Small-raised-red rash from head to feet. No c/o tightness of chest or SOB. C/O nausea. Took BENADRYL 2 PO about 2 PM decreased rash.
Flu shot was given to me in my left arm around shoulder. I jumped as the shot was administered feeling like a nerve was hit. Right away my whole arm was numb so I rubbed it and my arm felt warm. Pain did not go away and was very achy. Ever since I have muscle pain and not able to move my left arm in certain direction. I definitely can not sleep because moving makes my arm hurt. The pain will go from my shoulder to my elbow and it is a shotting pain feels like in the muscle. My arm is also very weak and not able to pick something up without the pain. I have spoke with my doctor and says it is common but have found on the web others complaining and having the same symptoms. I have tried ibuprofen and trying to strenght it but nothing seems to help. This has been going on for over a month and I don't see it getting better. Others have had the problem for 3 months.
This spontaneous report as received from a 72 year old male consumer refers to himself with high blood pressure and allergy to unspecified sulfa. In April 2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# not reported, one time vaccine, route reported as vaccine). Concomitant therapies included LYRICA, losartan potassium (manufacturer unknown) and omeprazole. On approximately 27-OCT-2014 (reported as "about 6 weeks ago") the patient started to experience "nerve pain on left side, middle of his stomach to around the back part of his back. The patient had sought medical attention. The patient had ultrasound done on an unknown date in 2014 which came back negative and was then prescribed LYRICA for pain. No other lab diagnostics studies were performed. Outcome of the event was unknown. The causality was not provided. Additional information has been requested.
Patient stated 3 fingers of her right hand and right leg are numb since the shot was given. Advised patient to see a doctor about the adverse reaction and followup with us after the appointment.
Vomiting the night of the vaccine. Low oxygen and high fever next morning. Has been on palliative care   Was hospitalized, but section 21 will not let me fill the info. Hospital  Admitting Dx:  Sepsis, likely biliary cause;  Acute on chronic encephalopathy likely sepsis related Returned 1/12 on hospice
Patient had two doses of the Moderna vaccine a week apart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had two doses of the Moderna vaccine a week apart) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had two doses of the Moderna vaccine a week apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had two doses of the Moderna vaccine a week apart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
patient without any antecedent events developed a spontaneous tension pneumothorax of Left lung, requiring  chest tube insertion, and VATS; Blebs found on CT, so VAT done; hospitalized for 48-72 hours; negative history of drug use/abuse; no recent URI symptoms, no environmental activities to set this into motion; was studying when chest pain ensued with dyspnea; seen in followup on 1/26/22 and doing well.
Little rash on arm left arm that itch; Welts (like insect bites) on both of arms and hands that itches like crazy; Rash on my arm my left arm that itch/ both of arms and hands that itches like crazy; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Apr2021 at 08:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknow if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730) via an unspecified route of administration in the left arm on 09Apr2021 at 08:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. On 04May2021 at 10:00, the patient started to experience a little rash on arm (left arm) that itch, to welts (like insect bites) on both of her arms and hands that itches like crazy. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure was taken as a result of the events which included treatment methyl predisolone on an unspecified date. The clinical outcome of the events little rash on arm (left arm) that itch, welts (like insect bites) on both arms and hands that itches like crazy were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
About 4 weeks following vaccination, patient had pain and swelling on the posterior aspect of the L-knee. He could barely flex the knee, and it became discolored initially dark blue and then yellow which extended halfway up the posterior thigh.  HE was evaluated by various physicians.  Ultimately was diagnosed with hematoma that was aspirated - described as old blood.  Cultures were negative.  Was feeling better afterwards, but noticed more pain in L-calf.  Venous duplex ultrasounds showed no evidence of blood clots.  Patient was referred to infectious diseases to evaluate possible ADE secondary to vaccination.
PATIENT GOT VACCINATED ON 11/7/2017 AFTERNOON AND HAD VOMITING THE SAME NIGHT. SHE HAD FEVER OF 100.5F. THE NEXT DAY SHE DEVELOPED RASHES ON HER WRIST AND ANKLE AND TOOK BENADRYL FOR 2 NIGHTS. TALKED TO HER ON 11/9, 11/10 AND 11/11. SHE IS DOING GOOD NOW AND DOES NOT HAVE ANY RASHES ANYMORE.
Narrative: Pt reported blotchy red rash on upper extremities, hand shaking, sweating, and feeling of heart racing (HR 155) approximately 15 minutes after receiving first dose of Moderna COVID-19 vaccine. No SOB, throat swelling, itching. Reported some chest tightness but no pain. Symptoms resolved without treatment.
flu-like symptoms; chills; HEAT (FELT EXTREMELY HOT); fever; ache; in and out feeling of hot and cold; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, at 3 the subject experienced flu-like symptoms. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, at 6,the subject experienced heat (felt extremely hot). On 12-MAR-2021,at 6 the subject experienced fever. On 12-MAR-2021, at 6 the subject experienced ache. On 12-MAR-2021, the subject experienced in and out feeling of hot and cold. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, ache, and heat (felt extremely hot), and the outcome of flu-like symptoms and in and out feeling of hot and cold was not reported. This report was non-serious.
Information has been received from a nurse practitioner concerning a 23 year old female who on 09-JAN-2009 and 09-MAR-2009 was vaccinated with her first (lot number 661764/0650X) and second (lot number 661952/1129X) dose of GARDASIL 0.5ml IM into her deltoid respectively. Concomitant therapy included NUVARING. The patient did not have any reactions after the 1st dose of GARDASIL. On 09-MAR-2009, 2 hours after the vaccination the patient developed nausea. On 10-MAR-2009, one day after the vaccination the patient experienced a severe headache. Unspecified time the patient experienced migraine. The nurse practitioner felt an intervention to prevent serious criteria was "the patient received NSAIDs". The patient sought medical attention by phone and an office visit. The patient's outcome was recovering. Additional information has been requested.
On 1/26 am, mom noticed raised area at DTAP site. Brought child to clinic 1/27. Still indurated at 30mm x 30mm. Full ROM, afebrile, playful.
7 days after, developed swelling,redness,rash, and swollen lymph gland
sick for 4 days; Vomiting; headaches /  escalated to the second shot, which was even worse; aching all over body /  escalated to the second shot, which was even worse; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 4 days), VOMITING (Vomiting), HEADACHE (headaches /  escalated to the second shot, which was even worse) and MYALGIA (aching all over body /  escalated to the second shot, which was even worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis.Concomitant products included IBUPROFEN and NAPROXEN SODIUM (ALEVE) for Arthritis.On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (sick for 4 days), VOMITING (Vomiting), HEADACHE (headaches /  escalated to the second shot, which was even worse) and MYALGIA (aching all over body /  escalated to the second shot, which was even worse). In February 2021, ILLNESS (sick for 4 days) had resolved. At the time of the report, VOMITING (Vomiting) outcome was unknown and HEADACHE (headaches /  escalated to the second shot, which was even worse) and MYALGIA (aching all over body /  escalated to the second shot, which was even worse) had not resolved. After first dose Patient experienced bad reaction. She thought she got over it, but she didn't. She has headaches, aching all over her body. It escalated to the second shot, which was even worse. She is wondering if anyone else is experiencing the same thing. Consent declined for safety to contact the patient's HCP. She taken booster dose on 12-Nov-2021This case was linked to MOD-2021-387075, MOD-2021-387124 (Patient Link).
fever; headache; fatigue; swelling; Hardness; Injection site soreness; A Spontaneous  report was received from a consumer concerning a Female patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pyrexia, Headache, Fatigue, Injection site swelling, Injection site induration and injection site pain. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination   On 11 Feb  2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)  via unknown route and unknown location for prophylaxis of COVID-19 infection .   On unknown date Patient developed Pyrexia, Headache, Fatigue, Injection site swelling, Injection site induration and injection site pain.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the event Pyrexia, Headache, Fatigue, Injection site swelling, Injection site induration and injection site pain was reported as unknown.
Breakthrough case admission after three vaccines 1/26/21 Moderna 032420A 2/25/21 Moderna 011M20A 11/20/21 Moderna 013F21A
Slightly swollen around injection site, itching - started 3/5 and somewhat worse 3/6/21.  Not significant enough to see medical professional.
The evening after receiving the vaccine I experienced extreme vertigo (unable to sit upright or stand); The evening after receiving the vaccine I experienced extreme vertigo (unable to sit upright or stand); nausea; headache; chills; dizziness; weakness; This is a spontaneous report from a contactable consumer. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in arm left on 13Feb2021 at 09:30 as single dose for COVID-19 immunization (at the age of 38-years-old). The patient medical history included known allergies to Compazine, Rocephin, Penicillin, Erythromycin, Mushrooms and Arugula. Patient concomitant medication(s) included Multivitamins/CBD Oil (equilibria). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Feb2021, at 18:00, the patient stated that the evening after receiving the vaccine she experienced extreme vertigo (unable to sit upright or stand), nausea, headache, weakness, dizziness and chills. Patient was pescribed meds to stop vertigo but nausea, weakness, dizziness and headache persisted for 11 days following vaccination. The patient received treatment of Scopalomine patch for vertigo. On 21Feb2021, the patient underwent lab tests and procedures which included Nasal Swab and ID NOW were negative. On 23Feb2021, Nasal Swab and PCR test were negative. The outcome of events was recovered with Sequel.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 13-JUN-2017, the patient was vaccinated with an improperly storage dose of PROQUAD (dose and route were not reported) lot number N002915, expiration date 24-JUL-2018. The temperature excursion was from -14 degrees Celsius to -10 degrees Celsius for 390 hours, 55 minutes and in the range -9 degrees Celsius to 8 degrees Celsius (-1C) for 5 minutes (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000678, 1707USA000679, 1707USA000680, 1707USA000682). Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000678: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000682.
lethargy, fatigue, unable to get up from the floor, more mental fog then usual, O2 levels low, pick up by ambulance and hospitalized on Friday 8/5/22 expected to be transferred today to rehab facility. Local Hospital.
47 year old male admitted with chest pain, elevated troponin, found to be Covid 19 positive. Pt denies any health hx, he follows with a PCP yearly he reports. Pt developed exertional chest pain which began 30 minutes prior to arriving to the ED overnight. he had EKG initially showing acute ST elevation in leads V1-V2, lateral leads with Q wave and ST/T wave changes. Initial troponin 71,2, 1845  . Pt denies any hx of previous MI, stroke or DM2. he reports he works as a software engineer. Pt reports some mild midsternal chest pressure this AM. he denies SOB, edema, orthopnea.    INPATIENT AT THIS TIME.
Patient came to location with her twin sister to get her first Pfizer COVID vaccine.  She had a vasovagal response at the same time as her sister.  She was laid down and recovered in 20 minutes.
pt recv vax & 2 days later pt devel an inj site rxn;rxn consisted of swelling & an 8cm area of redness, pruritis, warmth, & induration;this is one of two pt from this site to develop inj site rxn following receipt of vax;
This case was reported by a healthcare professional and described the occurrence of pruritus all over body in a 47-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included AMBIEN, Atorvastatin and LIPITOR. On 18 September 2012 the subject received unspecified dose of FLULAVAL (.5 unknown, unknown, right arm). On 18 September 2012, 1 hour after vaccination with FLULAVAL, the subject experienced pruritus all over body, erythema all over body, swelling all over body and pharmaceutical product complaint. The subject received FLULAVAL injection on 18 September 2012. Approximately one hour later, the subject began to experience redness, swelling and itching all over their body. The symptoms resolved the next day on 19 September 2012. The healthcare professional considered the events were probably related to vaccination with FLUVALAL. A product complaint was filed, due to "the symptoms are unlike any flu vaccine she (the reporter) has ever seen occur". These subjects were "three in a row, which prompted her to call. The reporter was not sure 100 percent if the vial was suspect or not, and requested that a Quality complaint be submitted, and the vial to be returned for analysis." This is third of three reports made by the healthcare professional, please also see A0995170A and A0995173A.  On 09 October 2012, follow-up information was received from the healthcare professional. It was reported that the pruritus all over body, erythema all over body, and swelling all over body had resolved. The reporter considered that the events were not serious. It was also reported that the immunization series with FLULAVAL was discontinued and was not delayed. According to product complaint investigation results reported by GSK Biologicals quality assurance on 09 October 2012, the product complaint was assessed to be unsubstantiated.
Felt extreme soreness in both shoulders; Radiating down to my arms, elbow, joint areas / radiating  pain in the shoulder and elbow joints.; This is a spontaneous report from a contactable healthcare professional, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04Jan2021 at 12:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and reported as otherwise in good health. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), vitamin D nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN), all taken for unknown indications from unknown dates. The patient previously took bactrim and sulfur drug and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021, the patient experienced extreme soreness in both shoulders radiating down to arm, elbow, joint areas. It had been over three months since those shots, and she continued to have radiating pain in both shoulder and elbow joint areas. She had a full physical about two weeks ago from the time of this report and was in good health, except for the radiating pain in the shoulder and elbow joints. On 01May2021, the patient underwent COVID test (nasal swab) and the result was negative. The clinical outcome of the events extreme soreness in both shoulders radiating down to arm, elbow, joint areas were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 09/14/2021, Patient was given her 2nd Pfizer vaccine 6 days before the recommended time between the 1st and 2nd dose.
Dizziness, fever, fainting, ER visit for fluids, unable to stand for long periods, low BP, high pulse (average 110-120 heart rate upon standing).