chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired; Slight chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and CHILLS (Slight chills) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired) and CHILLS (Slight chills). At the time of the report, FATIGUE (Tired) and CHILLS (Slight chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-269841.
Horrible headache and aches in joints and in the muscles, especially elbows, hips and knees, began in the evening after the injection and worsened the next day.  The joint and muscle pain in the hips and knees was almost unbearable. Two days after the injection, the pain has begun to subside, still some aches in hip area but headache has gone away.
SORE ARM; A BIT OF HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: sinus.  On an unspecified date, the patient received vaccination with covid-19 vaccine ad26.cov2.s unspecified manufacturer (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 01 total, administered for prophylactic vaccination. (Dose number in series 1) No adverse events associated with previous covid-19 vaccine ad26.cov2.s vaccination were reported.  On 19-NOV-2021, the patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number and expiry were not reported) dose was not reported, 01 total, administered for prophylactic vaccination.(Dose number in series 2) 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 19-NOV-2021, the patient experienced sore arm and a bit of headache.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from sore arm, and a bit of headache.  This report was non-serious.
Extreme/severe pain upper arm. Unable to lift elbow level Above shoulder until December 7th. Unable to lift elbow period until Thursday. Took ADVIL for pain.
Information has been received from a woman in a physicians office concerning  a 9 year old male who on 07/02/ 1996 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 01/24/2005, the pt developed a  rash on he face and back.. It  was noted that the pt was exposed to chicken pox the week before developing the rash. on 01/25/05 th pt was seen in the office and a diagnosis of varicella was made. supportive care was ordered . At the time of this report, the outcome was unknown. Additional information has been requested.
One hour after receiving hepatitis B vaccine and flu vaccine, patient became agitation, with mental status changes with no clear cause, headache with a stiff neck, overall malaise, myalgia and a fever. Patient admitted for observation. Given acetaminophen and tests were performed to rule out an infectious process.
Severe headache, tachycardia, low body temperature (34.9c), severe pain in the right armpit and a little on the left, severe pain in the bones and joints. Strong pain in the abdominal area, diarrhea, dizziness and nausea. Pain in the back when breathing. shooting pains in different parts of the body.
tired/fatigued; chronic dry eyes have gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/fatigued) and DRY EYE (chronic dry eyes have gotten worse) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired/fatigued) and DRY EYE (chronic dry eyes have gotten worse). At the time of the report, FATIGUE (tired/fatigued) outcome was unknown and DRY EYE (chronic dry eyes have gotten worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She has chronic dry eyes and they seem to have gotten worse after the vaccine.   No concomitant product was provided by the reporter. No treatment medication was provided.
given a patient 1ml of Fluzone Quadrivalent instead of .5ml dose/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient who received 1ml dose instead of 0.5ml dose vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to overdose NOS..  It was reported that no adverse event was noted.  Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Contact with and (suspected) exposure to covid-19  Encounter for pre-operative laboratory testing  Abdominal aortic aneurysm (AAA) without rupture   Aneurysm of right popliteal artery
pt devel a h/a & soreness of the arm p/recvd flu vax;
Saddle blood clot in lung. Place in ICU for 1 day. Then regular room. Heparin drip to Apixaban. No activity. All medical tests indicated no  cause of blood clot. Vitals great. Past out twice and threw up night it started
pt recv vax 10NOV98 & 19NOV98 broke out w/rash on face & trunk (papular scattered);had fever 16NOV98 - 19NOV98 irritable, occasional cough;on ATB as well for OM;
Patient received dose 1 pfizer on 11/5/2021, but then on 11/30/2021 was given  a 5-12 year old dose as dose 2. No adverse events reported.
she began to have the memory issues and are progressively getting worse; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, in the last 4 weeks she began to have the memory issues and are progressively getting worse. Caller states that prior to taking the Pfizer COVID vaccine she never had issue with memory. Patient describes her issues as follows, she had a problem with her attention and cannot think, do not want to think, and had a lot of things to do. Patient was ashamed that she cannot pay attention or remember what she was supposed to do. Patient had spoken to other people, she did her own study.  Follow-up attempts are needed. Information on the lot/batch number is expected.
The pt developed hives on 4/23/00 and was seen in the MD's office on 4/28/00. The pt was given Benadryl and then instructed to make appointment to return if not improving.
Patient came in with complaints of a pain under right armpit, began at 10:00AM. Pain is a 3-4 on a 1-10 pain scale. No swelling, redness or lymphadema noted. Patient instructed to take either Tylenol or Ibuprofen if needed. Call with any problems.
vertigo; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date after the first dose of the vaccine the patient experienced some severe side effects and vertigo. The patient asked if she should get the second dose. The outcomes of severe side effects and vertigo were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, Muscle Aches, Fever of 100.7, Chills Symptoms started first thing when I woke up and lasted all day. Woke up on day 2 after the second shot and symptoms were gone. Lasted around 24 hours.
Tightness of chest; Wheezing; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness of chest), WHEEZING (Wheezing) and FATIGUE (Fatigue) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Tightness of chest), WHEEZING (Wheezing) and FATIGUE (Fatigue). At the time of the report, CHEST DISCOMFORT (Tightness of chest), WHEEZING (Wheezing) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-359055 (Patient Link).
Thigh cramps; Traveling pain to foot; Loose stools; Pain in hands; This spontaneous case was reported by an other and describes the occurrence of MUSCLE SPASMS (Thigh cramps), PAIN IN EXTREMITY (Traveling pain to foot), DIARRHOEA (Loose stools) and PAIN IN EXTREMITY (Pain in hands) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 immunisation.     No medical history was reported by reporter.     On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced MUSCLE SPASMS (Thigh cramps), PAIN IN EXTREMITY (Traveling pain to foot), DIARRHOEA (Loose stools) and PAIN IN EXTREMITY (Pain in hands). On 10-Apr-2021, MUSCLE SPASMS (Thigh cramps), PAIN IN EXTREMITY (Traveling pain to foot), DIARRHOEA (Loose stools) and PAIN IN EXTREMITY (Pain in hands) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs are provided.  Treatment includes Tylenol   This case was linked to US-MODERNATX, INC.-MOD-2021-047875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047875:MOD21-055918
Pt with hx of generalized anxiety.  Pt reported similar response after steroid injections which lasted approx 1 week on and off.  Pt felt anxiety, soa, dizziness and flushed.  BP initial at 159/110 and heart rate 91
Blurred vision, thirst, increased unination in mid-August 2002. Developed diabetes mellitis (type 1) 2.5 to 3 monthes after vaccine.
suspected vaccination failure/got the worst case after getting the jab think VACCINE; got the worst case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 89-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's friend. Age at vaccination was not reported. The patient had received the jab and got the worst case of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Headache, Vomiting, Chills occurred about 30 minutes after vaccine.
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 9-month-old 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Feb-2023, 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 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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 EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 9th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up information received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up information received includes suspect vaccine batch number was added. On 28-Feb-2023: Follow-up information received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Patient complained of face numbness around jaw area and inside cheeks. States "I feel like I went to the dentist and got a shot of Novocain".  Patient notified staff  at 1530, 15 minutes after receiving the vaccine. Patient denies difficulty breathing or difficulty swallowing. No rash noted. 30 minutes post vaccine patient states "It is getting better now but I still have some numbness". Patient denied difficulty breathing or difficulty swallowing. No rash noted. No other symptoms reported.
Headache, muscle weakness, joint stiffness, numbness and tingling in my face, hands and arms.
COULD NOT WALK; LEGS HURT SO BAD FOR 3 DAYS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from social media a patient via a company representative concerned a male of unspecified age, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: a medical condition on the spine (spinal arteriovenous malformation (AVM)). On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s, (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, (Dose number in series: 1) 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced legs hurt so bad for 3 days and couldn't walk (Dose number in series: 1). The patient recovered from legs hurt so bad for 3 days and outcome of couldn't walk was not reported. On an unspecified date after series 1, the patient had received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (form of admin, route of admin, and batch number were not reported) dose was not reported, (Dose number in series: 2) 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced legs hurt so bad for 3 days and couldn't walk (Dose number in series: 2). The patient recovered from legs hurt so bad for 3 days and outcome of couldn't walk was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which is off label use, and inappropriate schedule of vaccine administered (Dose number in series: 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported On an unspecified date, the patient experienced could not walk, and legs hurt so bad for 3 days (Dose number in series: 3). As per reporter it was reported that "I have taken all three doses. I have a medical condition on the spine (AVM). With each dose my legs hurt so bad for 3 days I couldn't walk. Not sure I want to go thru it again." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs hurt so bad for 3 days, and the outcome of could not walk, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220220578 (Dose series 1) and 20220222825 (Dose series 2).
Mild chickenpox illness <50 spots. No fever. Resolved in 3-4 days.
Information has been received from a nurse and concerning a patient of unknown age and gender. There was no information about patients' concurrent conditions, medical history or concomitant medications. On 21-MAR-2017 , the patient was vaccinated with a dose of improperly stored ROTATEQ lot # 007307 and expiration date of 30-NOV-2017, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celsius degrees (11.25 Celsius degrees) for 24 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1801USA006247: US-009507513-1801USA006860.
mild headache/I felt a little headache; tiredness; I had injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (I had injection site pain), HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 062G20A) for COVID-19 vaccination.     Concurrent medical conditions included Stroke. Concomitant products included EZETIMIBE (ZETIA) for Cholesterol.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (I had injection site pain). On an unknown date, the patient experienced HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness). At the time of the report, INJECTION SITE PAIN (I had injection site pain), HEADACHE (mild headache/I felt a little headache) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
Information has been received from a physician concerning a 14 year old female patient with seasonal allergies who on 11-JUN-2008 was vaccinated with the first dose of GARDASIL (Lot number 659653/1448U) 0.5 mL intramuscular in the right arm. On 11-JUN-2008, the patient fainted after her initial GARDASIL, she reportedly fainted in the office with "seizures like movements", then became responsive immediately after. The patient sought medical attention in the office and was sent to the emergency room (name unspecified) but was not admitted. The patient did not continue with the series. Seizure was considered to be an other important medical event. Additional information has been requested.
It first started with what I thought was itchy scalp and little hair loss  in august 2021 so I went to my pcp Dr and was prescribed clobetasol. That didn?t work as I started seeing more hair loss so I went to dermatologist #1 and was prescribed  ciclopirox 1% and spironolactone 50 mg for alopecia and seborrheic dermatitis. I saw no change with the hair loss and went to get a second opinion. I saw dermatologist Dr with Dermatology and she did a scalp biopsy and it came back with non scarring alopecia so increased my spironolactone to 100 mg and suggested I could try prp on my scalp. I had my first prp scalp injection done on 03/30/2022 at Dermatology.
Initial and follow-up information has been received from a physician concerning a 20 year old female student with allergies to amoxicillin, nickel, silver, and gold, who, on 22-JAN-2008 was vaccinated in the left deltoid with her first dose of Gardasil (lot# 659657/1487U). There were no illnesses at the time of the vaccination. Subsequently the patient experienced neurological symptoms and numbness down her arm 2 weeks after receiving the vaccine. On 14-FEB-2008 the patient experienced a sudden onset of decreased vision in her right eye that persisted. The patient was referred to a neurologist. An magnetic resonance imaging (MRI) was performed and was consistent with demyelinating disease. A lumbar puncture was performed and was consistent with inflammation. A computed axial tomography scan (CT) showed white spots on her brain, indicative of an autoimmune reaction. The patient was diagnosed with acute central nervous system demyelinating type inflammatory disease, three weeks after her first dose of Gardasil (Lot# 659657/1487U). At the time of the report, the patient had not recovered. The physician considered the acute central nervous system demyelinating type inflammatory disease, and decreased vision in the right eye to be disabling. This is one of two reports from the same source. Additional information is not expected.   4/28/2008 Neuro eval of 4/21/2008 received. Pt reports onset of decreased vision in the R eye which worsened over the following few days. Some pain reported when looking to extreme right or left. Seen for ophth consult 3/25/08 with DX: Acute viral keratoconjunctivitis. Seen in F/U by Neuro 4/2/08 with c/o tingling in the R upper and lower extremities and gait disturbance affecting the R lower extremity. Improvement noted with medrol dose pack.  DX:  Demyelinating disease NOS, either due to recent Gardasil vax or MS