chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Call off work; Chills; Fever; Joint hurts; Shortness of breath; Bone hurts; Sore throat; Body aches; Accumulation of secretion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), BONE PAIN (Bone hurts), OROPHARYNGEAL PAIN (Sore throat), PAIN (Body aches) and SECRETION DISCHARGE (Accumulation of secretion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath), BONE PAIN (Bone hurts), OROPHARYNGEAL PAIN (Sore throat), PAIN (Body aches), SECRETION DISCHARGE (Accumulation of secretion), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Joint hurts). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (Call off work). At the time of the report, DYSPNOEA (Shortness of breath), BONE PAIN (Bone hurts), OROPHARYNGEAL PAIN (Sore throat), PAIN (Body aches), SECRETION DISCHARGE (Accumulation of secretion), IMPAIRED WORK ABILITY (Call off work), CHILLS (Chills), PYREXIA (Fever) and ARTHRALGIA (Joint hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication was not reported treatment information was not reported
Very fast blood flowing, the heart beat for the whole time; Fatigue; feel sick and is still sick; Weakness; but feels very feverish all the time.; soreness in her arm; I had a swollen arm that was painful for 4 days; This is a Spontaneous report from a contactable consumer (patient) and Other HCP.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Mar2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included neutropenia.     The patient's concomitant medications were not reported.  She was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine on 27Mar2021. She is supposed to schedule her second dose of Pfizer-BioNTech COVID-19 Vaccine for this weekend. She reported having very swellingness of her arm, her arm hurt for 3-4 days on 28Mar2021. But this last weekend she has gotten to feel sick and is still sick, very weak in Apr2021. She does not have a high fever, has no fever, but feels very feverish all the time in Apr2021. She gets these kind of symptoms, these kind of flu-like symptoms all the time because she has neutropenia where she has very, very low white blood cells, so she gets sick very frequently. She had fatigue, very fast blood flowing, the heart beat for the whole time.  The patient underwent lab tests and procedures which included covid-19: pending on 12Apr2021. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
blistering rash - bullous pemphigoid, steroids, admitted to hospital pending further evaluation.
After the second dose on 6/14/2018 I developed mild leg weakness (hip extensors) and numbness on right calf going down foot.  Over June and July it stayed the same.  I was active however, as someone who did a lot of exercise daily (2.5 hrs) I had trouble.  On September 8th I woke up and could not walk from the waste down.  Hospitalization diagnosed transverse myelitis.
This spontaneous report as received from a licensed practical nurse refers to unspecified patientts of an unknown age and gender. Concurrent conditions or medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe fatigue that lasted about a week. Headaches and nausea and sleeps for about 11hrs a day.
Got shots yesterday morning, this morning mom noticed rash on back, gave a bath, got worse, spreading. By the time I saw him in the afternoon, 1/10/19-still some urticarial with back, monitor rash on face.
Pt was administered a second booster dose of Moderna.  Pt received the first booster of Pfizer 12/28/2021.  Pt is 18 years old Pt experienced a sore arm  the day after injection ,this resolved in 24 hours,   no other side effects
None reported; error in administration--patient not eligible for 2nd booster per CDC guidelines at time of vaccination.  <50 Not moderately/severely immune compromised at time of vaccination; previously received 3 doses of Moderna (3/17/21, 4/14/21, 12/13/21) per system
who is feeling dizzy and nauseous after receiving the second dose.; who is feeling dizzy and nauseous after receiving the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 04May2021, outcome "unknown" and all described as "who is feeling dizzy and nauseous after receiving the second dose.".  Additional Information: Caller was calling on behalf of her husband, who was feeling dizzy and nauseous after receiving the second dose. She wanted to know if this was normal. She just received the 2nd dose of vaccine today and warm transferred to PMI. Created Manual AE. Medical questions was referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Last dose in February. Symptoms started in March as crawling skin then reoccurring hives. it became constant and worst. It is pressure, food and heat reactive and flares despite those conditions.  I have to take Allegra every day. If not it will break out in hives. I did an allergy test after the vaccine and all of a sudden had all these allergies to foods I normally eat.  Before this, I never had hives in my life.
April 9 (Day 2): severe hotflashes, night sweats, severe arm pain April 10 (Day 3): severe hotflashes, night sweats, moderate arm pain April 11 (Day 4): swollen lymph node (near left side of neck above collar bone) severe hotflashes, night sweats, mild arm pain April 12 (Day 5): swollen lymph node (near left side of neck above collar bone) severe hotflashes, night sweats, mild arm pain April 13 (Day 6): swollen lymph node (near left side of neck above collar bone) mild hotflashes, night sweats
Narrative: COVID infection following COVID vaccine series 02/11 Moderna , dose #1 03/15, Moderna , dose #2 02/15 COVID swab, result: NOT detected 09/18 FIBRINOGEN: 331 09/18 DDIMER: 0.84 09/18 ERRITIN 330.8 09/18 COVID swab, result: detected 09/19 TROPONIN I <0.016 09/19 FIBRINGOGEN: 317 09/19 DDIMER: 0.77 09/19 ESR 29 09/20 FIBRINOGEN: 342 09/20 DDIMER: 0.77 09/20 ESR 33 09/20 COVID swab, result: not detected 08/03 PT cc: exposure: unknown 09/18 CXR impression: No acute cardiopulmonary findings.
This initial spontaneous case, initially received on 10-Nov-2017 was reported by other health professional (pharmacist), concerns a 75-year-old, elderly, female patient. It was reported that, the patient had no allergies, current condition included high blood  pressure and the concomitant medications included losartan for high blood pressure. On 15-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 179303, expiry date: not reported). On 19-Oct-2017, the patient felt like sunburn on her skin and developed a very bad rash all over the body, high fever, chills. On an unspecified date, a couple of blood tests and a skin biopsy was performed. The patient was hospitalized on 24-Nov-2017 and discharged on 25-Nov-2017. The results of the tests would be known on 06-Dec-2017. It was reported that, the patient was diagnosed with keratosis pilaris rubra by the physician. The patient still thought that, it was because of the vaccine, so she went to another hospital for a new diagnosis. The patient had a shot of KENALOG but it did not help. At the time of this report, the patient had not recovered from the event. The reporter assessed the causality as related to the  suspect vaccine. The reporter assessed the case as serious. Follow-up report received on 28-Nov-2017: Indication for concomitant medication (losartan) was updated as high blood pressure and current condition was updated as high blood pressure. Seriousness criteria "hospitalization" was added. Hospitalization dates (admission and discharge date) were added. On an unspecified date, a couple of blood tests (unspecified) and a skin biopsy was performed, the results of which would be known on 06-Dec-2017. It was reported that, the patient was diagnosed with keratosis pilaris rubra. The patient still thought that, it was because of the vaccine, so she went to another hospital for a new diagnosis. The patient had a shot of KENALOG but it did not work. Amended narrative accordingly.
Fever for 16-18 hours. Left arm hot & swollen up for at least 4 days, ached all over, like the flu, fatigued & tired for a very long time, several weeks.
jittery; sweating; could not sleep; hyperactive; restlessness; Lost 2.5 pounds weight; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive) and RESTLESSNESS (restlessness) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder and Cancer.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive), RESTLESSNESS (restlessness) and WEIGHT DECREASED (Lost 2.5 pounds weight). At the time of the report, FEELING JITTERY (jittery), HYPERHIDROSIS (sweating), INSOMNIA (could not sleep), PSYCHOMOTOR HYPERACTIVITY (hyperactive), RESTLESSNESS (restlessness) and WEIGHT DECREASED (Lost 2.5 pounds weight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified heart medications.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 08-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
SARS-CoV-2 Ag Resp Ql IA.rapid~SARS-CoV-2 Ag Resp Ql IA.rapid performed on 7/19/21. Came back positive. Per documentation from case investigation interview, case manager charted, "symptoms began 7-17-21" which included nasal congestion, runny nose, headache and sinus pressure. Safely isolating at home.
On evening of immunization developed fever of 104.3, seemed, dizzy and off balance. Resolved by 3-10-08
I received a quadrivalent influenza vaccine but am unsure exactly which one. I developed a headache around 3 PM later in the day after receiving the flu shot. That night I developed a fever of 99.98 degrees F. I experienced a headache and total body achiness throughout the morning and into the afternoon/early evening the next day.
This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in arm in an unspecified number of  adult patient's who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The sales representative of other manufacturer called about the new product SHINGRIX and reported that she was just speaking with one of her pharmacists and sharing some data on adverse reactions that could occur post-vaccination. The pharmacist reported that she had been seeing a lot of arm soreness with the SHINGRIX vaccinations. The pharmacist did not name any specific patients and stated that she had been vaccinating quite a few patients and many of them complained about arm soreness. The sales representative did not know the dates of the adverse event. The reported arm soreness she believed occurred recently. She did not have the lot number, NDC, or expiration dates for the vaccines or any product information on hand. She did not know the dose. She believed they would be administered the medication if their doctor recommended it. She did not know the treatment dates. It was verified that she did not know any concomitant medications, other medical conditions, or investigations to report. The sales representative did not have the reporter's email address. The reporter's business details were provided. She did not have any patient identifying data to include initials, date of birth, age, sex, height, weight, or ethnicity. She did not know any of the prescribing physician's information. There was no product complaint to report. There was no medical information request. This case was 1 of the 6 cases reported by the same reporter.
11:24 when asked, voiced dizzyness and nausea, ambulated without assistance or event to cot and reclined. Vital signs taken were stable, Monitored longer and during periods she attempted to sit and stand under observation, Wheelchaired to vehicle under parental supervision at 12:14. No other complaints.
FEELING ABNORMAL/KNOCK ME ON MY BUTT FOR TWO DAYS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On DEC-2021, the patient experienced feeling abnormal/knock me on my butt for two days. On DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling abnormal/knock me on my butt for two days, and had not recovered from headache. This report was non-serious.
Client given normal saline instead of Pfizer vaccine. Client re-vaccinated 4/19/2021 with EW0162 IM in left deltoid.
Progressive ascending sensory loss/paresthesias, urinary and bowel retention. MRI with several demyelinating lesions in thoracic and cervical cord as well as brain.  Diagnosis not established by neurology at this time (labs/data still pending); patient hospitalized and treated with high dose IV steroids on 5/21, with improvement but not back to baseline by discharge on 5/26/21.
Pt experienced pain in right arm from elbow to neck, bruising from elbow to injection site and a knot at injection site,
did not feel well; fever; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Mar2021. It was unknown if the patient had any allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if the patient received any other medications within two weeks of taking COVID-19 vaccine. On an unknown date in Apr2021, the patient experienced did not feel well and developed a fever for approximately 1 day. It was reported that the patient felt fine, but for the subject period his symptoms were similar to when he had COVID-19 in approximately Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events did not feel well and developed a fever for approximately 1 day was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Information has been received from a certified medical assistant concerning an 18 month old male, who is otherwise healthy, who on 23-JUL-2008 at 10:30 was vaccinated SQ with the first dose of MMR II (rHA) (lot # 660202/0451X) in the right thigh. There was no concomitant medication. On 02-AUG-2008 the patient experienced "viral rash". The patient was seen in the ER but was not admitted to the hospital. The course of treatment and the outcome were not reported. A product quality complaint was not involved. Follow-up information has been received on 29-SEP-2008 from a B-vaccine form and emergency room records. It was reported that the patient has an amoxicillin allergy and history of vomiting and there was no illness at the time of immunization. On 30-JUL-2008, the patient had a fever to 102. On 02-AUG-2008, the patient had a red, macular, blanching, diffuse rash on face and torso (spreading out) and was seen in the emergency room. The patient was described as very fussy, the patient's temperature was 36.9 C. The patient was diagnosed with a viral rash/ after MMR II (rHA) rash. The patient was treated with TYLENOL (dose, and duration not reported) and to follow-up with the primary care physician. The outcome was reported as recovered/resolved (date not reported). No further information is available.
Pt immediately complained of dizziness. She then felt back pain and numbness in her hands. I called 911 and EMS arrived. They checked her vitals and stayed with her for about 30 minutes. She then began to feel better. Her daughter-in-law came to pick her up. She instructed to follow up with healthcare provider.
Received Vaccine on right arm on 3/20/23. That night patient got chills, fever, malaise, redness on arm is increasing.
Swelling & redness at injection site; pt complaint of numbness & tingling all along arm & hand.
chills; headache; fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was reported  No treatment information was provided   Reporter did not allow further contact
Very sore tender left arm x5 days. ..Relegated to full bed rest x3 days. Flu like symptoms including low grade fever, significant chills and shivering, nausea, complete lack of appetite and thirst, muscle aches, fatigue.
Brain fog, lasted about 10 days. Low grade fevers for about 10 days. Two heavy periods closer together than normal.
Patients reports swelling and progressive erythema of LUE below injection site. Patient reported lack of immediate pain, and ensuing discomfort accompanied by warmth of area around site of injection. Pt reportedly returned to pharmacy 3/7/2016 and triaged by pharmacist who reported above. Patient then was sent to doctor who upon exam did not reason for reaction. Noted possibly swollen lymph nodes in upper arm by patient. Patient received prescription for Medrol Pak on 3/7/2016. I F/U'ed with patient on 3/9/2016. Patient explained & confirmed above, patient reported minor improvements in redness and pain, patient main complaint was of itching since Monday. I also vaccinated husband on same day, no reaction or event occurred. Will attempt another F/U on Friday.
mother stated lt arm was red, swollen w/a hard lump. It was hot to touch & very painful.
First shot was Pfizer then had J&J because had allergic reaction same day as Pfizer then this was booster and it was Moderna. Just like with the  first vaccine which was Pfizer, I started to get a migraine within 10 minutes but this time instead of taking exedrin I was given an ice pack and went home to rest but did not take anything and had a migraine til the next day when severe flu type symptoms arrived. I had a low fever, extra fatigue and body aches for a week, I suddenly felt a bit better on the 6th day but then that same evening I felt ill again and eventually was dx with a sinus infection. I did not do a report after J&J but was severely ill for 48 hours then regular flu type unwell for a further week. After all 3 vaccines it took at least 6 weeks to feel the effects had minimized
Large localized reaction at injection site - itchy, swollen, firm red rash. No treatment. Reduced in size next day. Ongoing at time of report
Swelling in my arm, collar bone and neck. Difficulty breathing from 1:30 to 5:30 am