chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakness; Weight decreased; Violent; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 8CDPBC and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Weight decreased) (seriousness criterion hospitalization) and AGGRESSION (Violent) (seriousness criterion hospitalization). At the time of the report, ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) outcome was unknown.            No treatment information was provided. Action taken with the mRNA-1273 in response to the event is not applicable. Patient was currently admitted in the hospital and the doctors could not figure out the root cause of her illness.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
No adverse event. Patient received 3rd dose of vaccine when it has not been approved for his age yet.
Pt received a dose of moderna past expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pt received a dose of moderna past expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pt received a dose of moderna past expiration date). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Pt received a dose of moderna past expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. The reporter stated that the patient took either second or third shot but not the first shot. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: FU contains no new information. On 21-Oct-2021: Follow up received on 21-OCT-2021. Dosing details were added, phone number is provided. On 21-Oct-2021: FU contains no new information. On 21-Oct-2021: FU contains no new information.
Headache, queasiness, chills, exhaustion and strong pain in arm at site of injection.  All except the tiredness gone by following morning.
Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist; Burning and tingling on left side of of face, jaw; tingling on left side of of face, jaw; burning in breast; burning in arm and leg of left side of body; Chills; "flu" like feeling; Burning in chest and down left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 12:00 (Lot number: Ew1075) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: 9 months ago. The patient's concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist"; BURNING SENSATION (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Burning and tingling on left side of of face, jaw"; PARAESTHESIA (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "tingling on left side of of face, jaw"; BREAST PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "burning in breast"; BURNING SENSATION (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "burning in arm and leg of left side of body"; CHILLS (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as ""flu" like feeling"; CHEST PAIN (non-serious) with onset 11Aug2021 17:00, outcome "recovering", described as "Burning in chest and down left arm". Therapeutic measures were not taken as a result of bone pain, burning sensation, paraesthesia, breast pain, burning sensation, chills, influenza like illness, chest pain.  Additional information: Aches in bones all over body but worse on the bones in the left arm including shoulder, elbow, Wrist. Burning and tingling on left side of face, jaw and burning in breast, arm and leg of left side of the body. Chills and "flu" like feeling. Burning in chest and down left arm two days after the same as when I had Covid 9 months ago. No other vaccine in four weeks. Other medications were received in two weeks. Had covid prior vaccination. No covid test post vaccination.No known allergies and none other medical history.  Follow-up attempts are completed. No further information is expected.
For a period of about 20 min. the day after recieving vaccine, patient experienced breathing difficulties, heart palpatations, sweating, shaking, fever, watery eyes, redness of his face, dizziness, nausea. treated with Advil.
Developed localized cellulitis at injection site, Tx'd with azithromycin, prompt resolution, no sequelae or serious morbidity.
1st shot 3 days later swelling, fever, in right   arm & breast  next week later surgery     2 month later had nurse to put in     opposite arm swelling reaction from        neck down on left side lots of pain    no one told us of these side affects.  8/13/2007 MR received for ER visit 7/17/2007 for c/o swelling and tenderness in L deltoid.  PE (+) minimal induration at injection site and tenderness to palpation of the L back. DX: Local reaction to vaccination.
Severe rash, hives, swelling, burning and itchiness  on both arms, fingers,  scalp, torso,  legs, thighs, face, neck and ears.  Began on or around Feb 24 2021 and is still occurring as of October 2021.  I have been using hydrocortisone cream, aloe, triple antibiotic cream, topical analgesics, Benadryl, Aquaphor ointment and Ivarest cream.  As of today I still have all the above symptoms. I have seek medical attention now and I have an appointment with my PCP 10-4-21 and a dermatologist 10-13-21.
I had heavy mensural bleeding before the 1st dose, then after the 2nd lower back pain and body pains, 2nd or 3rd day for 4 or 5 months, blood clotting in Apr/May2012. In July I saw my doctor. Just on 2 weeks ago, I had  Varium swallow x-ray, feels like I am swallowing a ball and clicking sound, not while I am eating and drinking. After 2nd dose - body ache, low grade fever lasting 24 hrs.
Information has been received from a female registered nurse who is the patient via company representative refers of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose and lot number were not provided). On an unknown date, the patient administered the vaccination to herself, and had an injection site reaction. Nurse described the reactions as a hard silver dollar sized area of redness and swelling at the injection site. On an unspecified date, the patient recovered. Additional information is not expected.
Started shaking badly  and my heart was beating very fast and strong a few minutes after vaccine injected. Paramedic stayed with me until heart stopped beating so fast, shaking slowed down some. Slight shaking  continue for at least an hour.
Felt dizzy/faint and heart pounding. Given ice water and cool wash cloth, rest. Monitored, blood pressure 102/76. After 30 minutes continued to feel faint and dizzy with heart pounding feeling. Brought to Emergency Department for further evaluation.
Pt received Prevnar 13 in the office on 4/29. Pt came to clinic today with left upper arm red, swollen and warm to the touch just below injection site. Lot #J31687.
This spontaneous report was received from an healthcare worker regarding an 28 years old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, it was reported that the 28 years old patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (strength, frequency, lot #, expiration date and route of administration were not reported). No side effect were given. The reporter stated that she would double check that the patient was 28 years old. No Product quality complain was present.
This spontaneous report as received from a 56 year old nurse female patient concerning herself. On an unknown date (also reported as at an unspecified time in the past), patient had received MMR II booster (strength, dose and indication was not provided) and had measles in the past. Nurse stated, at an unspecified time approximately in 2013 (also reported as last year), she had equivocal (serologic testing) completed for MMR. Her measles titer came back negative when equivocal report was received. At an unspecified time approximately in 2013 (also reported as last year), patient received booster for MMRII (strength, dose and indication was not provided) based on equivocal results. No adverse effects reported. Product quality complaint (PQC) was not involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
The patient received the Fluzone HD vaccine instead of the Quadravalent that was indicated by her 61 years of age.
red rash on face, stomach, fever 100, knot of lt leg & redness;sx started 27SEP98;
Rash around vaccinated area; 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 VACCINATION SITE RASH (Rash around vaccinated area) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash around vaccinated area). At the time of the report, VACCINATION SITE RASH (Rash around vaccinated area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
PATIENT HAS ANAPHYLAXSIS TO BEE STINGS AFTER 20 MINPT C/O PHLEGMY FEELING IN BACK OF THROAT AND HER   MOUTH FELT WEIRD. PT WAS OBSERVED BP 145/88 O2 100%HR 81 SHE RESTED ON STRETCHER AT 1:40PM REPORTED   FEELING 90% BETTER AND SHE WENT HOME IF SX CHANGE OR GET WORSE WILL GO TO ER CALL MD
Upon awakening at 7 am on 3/8/2021 became dizzy, lightheaded and diaphoretic. Later in the day  had fever of 99.8, chills and extreme  fatigue. Left arm soreness
There reportedly were no pre-existing medical conditions, allergies or concomitant medications. At the time of vaccination, the pt had the "flu". PCR (polymerase chain reaction) analysis was performed and the vaccinee was reportedly found to have chlamydia pneumonia. He was also found to have "low WBC". On 1/16/91, 1/6/94 and 1/29/01, the pt received his 1st, 2nd and 3rd doses of Engerix-B and approx. 3 days after his 3rd dose, on approx. 2/1/01, he was reportedly dx'd with chronic fatigue syndrome. Reportedly, he also had palpitations, muscle soreness, headache, "cognitive dysfunction", dizziness, night sweats and a rash on his trunk. The pt has been unable to attend school. As of 5/22/01, the rash had resolved. The outcome of the chronic fatigue syndrome, palpitations, muscle soreness, headache, "cognitive dysfunction", dizziness and night sweats was not specified. Because the pt was unable to attend school, the events are considered incapacitating and this report is considered serious.
Red knot, quarter size where injection was given. It was warm to the touch. It was on left thigh.
This spontaneous report was received from a medical assistant and refers to a 38 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-AUG-2018, the patient was vaccinated with a dose of M-M-R II injection, lot # N023146, expiration date 24-AUG-2019, (frequency was not reported), that was administered intramuscularly, for prophylaxis. No adverse effects were reported. The vaccine was administered along with a sterile diluent.
Product storage error; possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients). At the time of the report, PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   There are 4 days temperature data for the freezer storage unit is between 1-Apr-2022 and 4-Apr-2022 however it never reached an acceptable range and was always warm by at least 2 degrees Celsius.  Between 22-feb-21 through 4/26/22 there is no other temperature data other than what is listed above. 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period. Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  The concomitant history was not reported. The treatment history was not provided.
Nausea, diarrhea, fatigue, fever, chills, body aches
Pt received her first dose of Shingrix on 1/21/22.  The day after receiving Shingrix pt developed fever, generalized weakness, chills, fatigue, and joint pains.  These symptoms persisted which lead to an admission from 1/30-2/9.  She experienced severe pain during admission which required IV pain medication.  During the admission she started to have numbness and weakness in her lower extremities followed by numbness and paresthesias in her hands/fingers.  She had an extensive workup including imaging (MRI C, T, Lspine) and lab work.  She was noted to have LFT elevation during admission.  She was d/c'd with the dx of polyneuropathy and advised to follow up with neurology.  She went home ambulating with a walker (baseline was independent ambulation) and saw neurology for follow up on 2/15/22.  During that visit neuro was concerned about possible GBS so patient was admitted from 2/15-2/18.  Work-up during that hospital stay included lumbar puncture (results c/w aseptic meningitis).  GBS was ruled out and pt was dx'd with post-viral mediated aseptic meningitis likely from recent Shingles vaccine.  Patient was started on steroids during hospital stay (IV) and d/c'd with oral prednisone taper.  She saw neuro for follow up on 2/22.  Pt's sxs have slowly been improving since d/c from second hospital stay
Fever; chills; fatigue; headache; loss of appetite; nausea; general malaise; neck pain; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK8734) via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 02:00, the patient experienced fever of 101.5, sustained fever over 101F after taking acetaminophen, chills, fatigue, headache, loss of appetite, nausea, general malaise and neck pain, after all other side effects were gone. On 08Apr2021, the patient underwent body temperature measurement and the result was found to be 101.5 degree farenheit (degF). On 08Apr2021 after taking acetaminophen again the body temperature was sustained to be 101 degree farenheit (degF). The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse event fever and included treatment with acetaminophen and no therapeutic measures were taken as the result of other adverse events. The clinical outcome of the events fever chills, fatigue, headache, loss of appetite, nausea, general malaise and neck pain were recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
HEARING LOSS; This spontaneous report received from a patient via social media concerned a female of unspecified age, race and ethnicity. 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Patient was on a diuretic and an antihistamine for about a month with no change. Previously had a course of steroid tablets (no effect) and three steroid shots in the eardrum. On an unspecified date, the patient experienced hearing loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hearing loss was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210905661 -covid-19 vaccine ad26.cov2.s- hearing loss. 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).
A very mild twitch began in my right upper lip that has grown slightly, is now sometimes on the other side and on the area between my nose and lip.  It occurred only occasionally at first, but has increased over time.  Though not noticeable by others, it is a slight distraction and mildly troubling because of my concern that it may worsen over time.  I hope this is not the case, but felt this feedback may prove helpful in some way.
p/vax pt exp severe lower back pain (like having been punched) in area of kidneys, both sides; very sore, kept pt in bed the day; h/a lasted 3 days; pain disappeared rapidly in approx 30hr;
sneezing; nose was running at a ridiculous pace/ nasal drainage; experienced itchiness in both of his armpits.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 17:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 (Batch/Lot Number: EN6198) on 26Feb2021 at 17:00 for COVID-19 immunization and experienced terrible sneezing/continuous sneezing day and night and runny nose/nose was running profusely/sniffles. He received a second dose on 18Mar2021 and 2 weeks later he began sneezing and nose was running at a ridiculous pace. This was continuing and had been going on for 5-6 days. He wears CPAP (continuous positive airway pressure) at night and it was having trouble keeping it on because of the nasal drainage. It was also reported that he was roughly 2 weeks or 13 days from that 2nd dose of the vaccine and about 3 days before he began profusely sneezing and still was sneezing and his nose was running and was producing the same as the prior time this happened and he tried taking allergy pills to see if it would subdue this and it did not subdue his symptoms. He received his vaccine dose in his left arm and he had experienced itchiness in both of his armpits. Treatment was received for sneezing and nose was running at a ridiculous pace/ nasal drainage. Outcome of sneezing and nose was running at a ridiculous pace/ nasal drainage was not recovered. Outcome of itchiness in both of his armpits was unknown.  No follow-up attempts are possible. No further information is expected.
made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said he/she had to take the 2 dose shot, made sick with the side effects. Here conservatively taken 2nd dose as suspect as no contact details were reported for follow up.