chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of appetite; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient's second shot was due on 12 Feb 2021.  No treatment information was provided.
pt recv vax dx allerg rxn to vax;no tx given;red papular rash on trunk & neck;
HCP confidently diagnosed me with Bell's Palsy. It came on suddenly and without much warning. I woke up to find that the right side of my face was weak - right eye hard to close, weak lower lip, and even foods/drinks had different or less taste. These symptoms have worsened a bit, most noticeable being my less active right eyelids and the weakness in my lips/face muscles (right side) makes it hard/embarrassing to talk or laugh, as my mouth becomes contorted.
Very sore arm later that day. 18 hours after vaccination, chills, aches, loss of appetite. Tylenol taken, and feeling better
Information has been received from a person in a pediatric office concerning a 6-year-old white female with no pre-existing allergies, birth defects, or medical conditions who on 30-Aug-2000 was vaccinated with a first dose of Varivax (lot# 634502/0538K). There was no illness at the time of vaccination. The child was well. Subsequently, on 13-APR-2006, the patient developed chickenpox. No medical attention was sought. The outcome was reported as recovered in April 2006. There were no relevant diagnostic tests or laboratory data. No additional information is expected.
Lymph Knot (Neck); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph Knot (Neck)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph Knot (Neck)). At the time of the report, LYMPHADENOPATHY (Lymph Knot (Neck)) outcome was unknown. Not Provided
Awakened 0300 the next day, Saturday  the 9th with chills, fever 2 degrees above normal, headache and left arm pain from deltoid to elbow. Went to work in ICU at 0638, feeling like i had been ran over by a truck. Fatigue and general malaise throughout day. Sunday, i had no problems. Monday morning awakened with diarrhea, I never have diarrhea!  I felt bad most of Monday. Tuesday today, i feel fine!
Delayed the 2nd dose of the vaccine for 44 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Delayed the 2nd dose of the vaccine for 44 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a physician concerning a healthy female who never had any problems, who in approximately October 2008, was vaccinated intramuscularly with her second 0.5mL dose of GARDASIL (lot number not reported). The physician reported that the patient "passed out within 24 hours of getting the second dose of GARDASIL" (in approximately July 2008). The series was discontinued after the second dose. The patient was sent to the emergency room for "a complete work up" and "all tests came back normal". The patient was not admitted. The physician noted that there was no adverse event after the first dose of GARDASIL. The patient recovered within an unspecified time. This is one of two reports from the same source. Additional information has been requested.
This spontaneous report was received from an 84 year old female patient with hypertrophic cardiomyopathy and codeine allergy. On an unknown date of 4 to 5 years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported). Concomitant therapies included losartan potassium (manufacturer unknown), metformin, TOPROL XL Tablets, and vitamins (unspecified) (all with unspecified manufacturer and dose). At the beginning of July 2013, the patient developed a rash on the right side of her breast extending under the arm and around to her back. The patient stated a few weeks later the pain accompanied the rash and she went to a walk-in clinic where she was diagnosed with "Shingles" and prescribed prednisone and NEURONTIN (manufacturer and dose not specified). No laboratory test was performed. The patient telephoned physician's office. The outcome of shingles was reported as not recovered. Additional information has been requested.
I don't remember how, or what time it was nor how I got to the floor, but I never experienced fainting, but I felt faint. I was very foggy, almost like unaware of me being on the floor. I am not sure if I fell or was trying to get into my recliner and landed on the floor. I landed on the floor first. I had absolutely no muscle control in my legs and barely in my arms to prop myself up to get into that recliner. As I was on the floor trying to get up, it was almost like I was paralyzed, then after a few mins I was finally able to get into the chair.
Ringing in my ears and reduced hearing.  Adverse events started 15-20 minutes after receiving vaccine.
More than 35 days between Moderna Covid-19 vaccines; sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) and PRODUCT DOSE OMISSION IN ERROR (More than 35 days between Moderna Covid-19 vaccines) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (More than 35 days between Moderna Covid-19 vaccines). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown and PRODUCT DOSE OMISSION IN ERROR (More than 35 days between Moderna Covid-19 vaccines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information was provided.
Typical sore arm; scratchy throat; trouble sleeping; grumpiness; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Typical sore arm), THROAT IRRITATION (scratchy throat), INSOMNIA (trouble sleeping), IRRITABILITY (grumpiness) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 027B21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MAGNESIUM for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Typical sore arm), THROAT IRRITATION (scratchy throat), INSOMNIA (trouble sleeping), IRRITABILITY (grumpiness) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (Typical sore arm), THROAT IRRITATION (scratchy throat), INSOMNIA (trouble sleeping), IRRITABILITY (grumpiness) and FATIGUE (fatigue) outcome was unknown.            No treatment drug details was reported.   This case was linked to MOD-2021-268156 (Patient Link).
Patient developed dizziness, lightheadedness 30 minutes after vaccine. Was treated conservatively as vasovagal, without resolution and was transferred to local ER for further workup.
"Described" dent in left deltoid muscle at site of Hepatitis A, Typhoid vaccination, noticed 3-4 months later.
raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein; raised cord was observed on the left armpit of the injection site arm; Bulging vein is dark; This spontaneous case was reported by a consumer and describes the occurrence of VASODILATATION (raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein), INJECTION SITE VASCULITIS (raised cord was observed on the left armpit of the injection site arm) and VEIN DISCOLOURATION (Bulging vein is dark) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VASODILATATION (raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein), INJECTION SITE VASCULITIS (raised cord was observed on the left armpit of the injection site arm) and VEIN DISCOLOURATION (Bulging vein is dark). At the time of the report, VASODILATATION (raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein), INJECTION SITE VASCULITIS (raised cord was observed on the left armpit of the injection site arm) and VEIN DISCOLOURATION (Bulging vein is dark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
Chills, fever, body aches, weakness, shortness of breath, extreme thirst, unable to sit up in bed, had to be supported to reach bathroom.  Lasted until approx 5 or 6 A.M. Felt too sick to get to hospital E.R.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23Dec2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23Dec2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23Dec2022).    No concomitant medications were reported.  It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 42 doses of 6M-5Y vaccine were administered after 30 day use by date to patients. Vial size was reported as 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case was reported for patient 29 out of 42 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Patient 1 (Master Case)
arm was sore; felt fatigued; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm and fatigue. On an unknown date, the outcome of the pain in arm and fatigue were unknown.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 5-APR-2022 Reporter's Comment: The patient received dose of Shingrix vaccine and arm was sore and felt fatigued the next day. The reporter did not consent to follow-up.
covid injection given on 7-22-2021  and ppd tb skin test given on 7-27-2021.  Results of tb skin test negative.  No reactions with either injection, however spacing interval is to close.
Metal taste and smell immediately after injection First evening, chills and headache, sore swollen arm Next morning chills and headache, sore swollen arm Second evening, fever 101.4, chills, headache
Pt had Johnsons and Johnsons vaccine  Pt presented to the ER with shortness of breath and left leg pain.  She had a CT and ultrasound that showed a PE.
Fever (to 102.4 F), shaking chills (rigors), myalgias, arthralgias
No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent booster vaccine.   No treatment products reported.
Patient called pharmacy on 12/19/22 and informed that she experienced itching all over body ( stomach, both arm, legs )at in 5. am next morning  (12/16/22) so took some Benadryl and feeling better now ( almost 80 %) recovery
HEPATITIS B SURFACE ANTIGEN POSTIVE. Information has been received from a physician concerning an adult female who in 2002, "one year ago", was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and tested positive for hepatitis surface antigen. Unspecified medical attention was sought. There was no product quality complaint involved. Follow-up information from the physician indicated that no adverse reaction was reported.
Narrative:  Patient present to medical center on 3/26/21 for administration of Moderna Covid vaccination. Approximately 30 minutes after receiving shot, patient developed shortness of breath for approximately 1 hour after which, the shortness of breath spontaneously resolved.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 02-MAR-2012, the patient received improperly stored VARIVAX dose 2, from lot # 669842/0931AA, expiry date 13-JUN-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Within hours of receiving vaccine I have had ringing in both ears as well as a muffled hearing.  This is something I did not have before receiving vaccine and has not went away nor gotten any better as of yet.  This is causing me to be dizzy from time to time throughout the day and a headache by the end of the day.  As well as loss of concentration, this is very distracting and bothersome.  Contacted my PCP and she advised the I see an ENT/ OTO still waiting for my appointment on 7/22/21 to see if they can help me.
Redness, edema and warmth noted (Lt) thigh day after imm. in office. Low-grade fever on eve. of imm -> resolved. "Knot" also noted by mom (Lt) thigh x 2 days after imm. on exam 10/15/12, (+) mild redness at site with no induration, warmth or tenderness.
pt recv vax 22JAN96 & 12APR96 a titer revealed lack of response w/ S. pneumoniae type 1 IgG 40, type 3 IgG 660, type 4 IgG 90, type 6B IgG 60, type 7F IgG 130, type 8 IgG 60, type 9N IgG 50, type 12F IgG 140, type IgG 120;
Symptoms includes fever, muscle ache, new loss of taste or smell, congestion or runny nose Cough Shortness of  breath or difficulty breathing  leading to hospitalization
After receiving first COVID vaccine, patient became lightheaded, nearly passed out, and nauseased. Patient was hypotensive and tachycardic, feeling chest tightness and lump in her throat. the sensation of tongue swelling occurred in the ED. Vitals were performed and the patient was given fluids. Initial vitals were 80/52, HR 89, O2 97% on RA while sitting up right. After 15 more minutes and after providing 400 ml to drink, her BP was 115/80 O2 sats 100%. When cardiac symptoms and throat sensation were expressed, the an RRT was called and the patient was taken to the ER for observation. In the ED she was given juice and observed. She was later discharged after monitoring.
rt upper arm swollen, warm, sl reddened;got shot pneumonia 22OCT98 rt arm 1PM;
Tingling in left hand for about 30 minutes  Tingling and numbness in lips.  Its been a couple hours now, and it feels like it might be starting to subside.
major cramps; whole body aches; headache; joint pain; leg drag; both arms, severe pain; stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain) and HEADACHE (Headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  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. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain), HEADACHE (Headache), PAIN (whole body aches) and ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (leg drag), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (major cramps), PAIN IN EXTREMITY (both arms, severe pain), HEADACHE (Headache), PAIN (whole body aches) and ARTHRALGIA (joint pain) outcome was unknown.            No relevant concomitant medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Client presented to receive Moderna Dose 2. Client received first dose Moderna on 01/06/22. The client reported the next day he developed shaking that lasted 4 hours. The client stated he was unable to move due to the shaking. The client also reported chills, pain at the injection site, and body aches. The client took two Tylenol which helped relieve his symptoms. The client did not seek care or follow up with PCP. The client has no chronic conditions or medications. No known allergies. History of COVID with hospitalization and intubation in August 2021. Client received approval to receive Moderna Booster COVID vaccine by MD. Client received Moderna Dose 2 Lot#084J21A.  Client reported no symptoms while waiting in observation area for 30 mins. Client left vaccination area in steady gait.
COVID-19 breakthrough. May 31 in the evening I had a low grade fever (100.5 degrees) it lasted for 48 hours. I had body aches and myalgias they lasted 4 days. I had a cough which also lasted for 4 days. I also had fatigue that lasted for about 5 days.
Redness, Sourness, Swelling, loss of appetite, thrust, weakness 9:00am 7-7-19