chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; fever; body aches; headaches; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 2nd dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced fatigue, fever, general body pain and headache. On an unknown date, the outcome of the fatigue, fever, general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, fever, general body pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the Shingrix and had severe fatigue like fever body aches and headaches cents.  The patient wanted to know about how long should this last. The reporter started to get concerned. Additional Supportive Information: The follow up would not possible as no contact details were available.
Patient came in 2 days post injection with red/tenderness and bruising at injection site, area was hot to touch. Instructed patient to use OTC analgesics to see if that soothed it and to come back tomorrow to let us see it again. Told her to watch to make sure it doesn't get worse.
CHEST PAIN; BILATERAL LEG SLEEPING AND LEFT ARM ALSO ASLEEP; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced bilateral leg sleeping and left arm also asleep. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, headache, nausea and bilateral leg sleeping and left arm also asleep was not reported. This report was non-serious.
Pt stated that after she left the pharmacy she soon felt paralyzed all over. She said it was an awful feeling she felt for days.  She did not go to the emergency room and said she will never go to a hospital. She is feeling better but still feels bad
full flu sx for about 12hr fever, chills, all over body aching (intense);
Low grade fever 2 days after injection developed runny nose, sore throat, extreme coughing (Thursday 10/2/14). Exam by PA at PMD office 10/7. Rx Azithromycin x 7 days, PA dx'd as "reaction to flu shot" by pt report. Completed atbx, cough worsened, pain with coughing. Exam by PMD 10/13, swelling LS spine. Cortisone injection. All symptoms improved by 10-15-14. Muscles sore.
Skin around injection site red and warm to the touch. Onset within 2 hours of injection with redness peaking at 36 hours. At its peak, redness measured 13 cm. Duration 5 days. No treatment.
Neck Pain, Stiffness in neck when turning or looking up or down; Pain and stiffness in left foot toes.
Left Deltoid with 3cm x 6cm oval; erythematous area; tender to the touch; pruritic rash - Good ROM od arm & shoulder.
I am 99% blind in my right eye. I get some dizzy spells. I went to the men clinic about my eye. They did all kinds of test on me. Everything came back normal. They said I had a mini stroke.
she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid; she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient reported that she took three of the Pfizer shots and there has been a gap in the shots for a while. Now she has tested positive for covid. Caller voiced "she had no immunity from the shots didn't work or now it has been to long spaced out. Is what she was thinking. Does that sound like what's happened or could she had just got one that the shots didn't work? Caller voiced that she has taken three Pfizer Covid 19 Vaccines since covid started. Per caller she thinks the last one was probably the very end of Oct. Caller asking now that she has covid and has taken the three Pfizer Covid Vaccines. The patient started Paxlovid and has taken 2 pills of Paxlovid, she also started with the evening dose of Paxlovid and has stopped taking Paxlovid as of now and has missed a few days of the Paxlovid as of now. She also reported her history of A-fib and asked if it was okay to take Paxlovid with Sotalol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fatigue, terrible fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "don't smoke"; "don't drink". The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue, terrible fatigue". The event "fatigue, terrible fatigue" required physician office visit. Therapeutic measures were not taken as a result of fatigue. Additional information: 2 or 3 days later like almost immediately, the patient experienced fatigue. The patient did not connect it to the shot at first and then she got the second one. The patient definitely feel and the patient's doctor also agreed that he had other cases that are experiencing the same thing.The patient also talk to the doctors and the doctor say well you just have to work through it, they don't seem to have any treatment. The patient don't drink and don't smoke. She was a good person. She like to workout. She like to take care of her home and take care of this but she can't. She was just too tired all the time. She have a hard time to get dressed in the morning. She would like some kind of help because she don't know where to turn.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201393742 same patient/vaccine, different event/dose;US-PFIZER INC-202201265296 same patient/vaccine, different event/dose;US-PFIZER INC-202201265277 same patient/vaccine, different event/dose;
Anaphylaxis, headache, bruising on legs and arms, stuffy nose, chills, fever, and sleepiness.
A few weeks after the vaccine, in late February I noticed trouble with my right hip and was no longer able to sit in a chair.  Previously my arthritis was very intermittent and since the onset of the difficulty sitting, my hip was in continual pain and I was unable to sit in a normal chair or automobile seat.  The arthritis now appears to be monoarthritis of the right hip, although my doctors insist it is osteoarthritis.
Issues with menstrual cycle.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Issues with menstrual cycle.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Cutaneous) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Issues with menstrual cycle.). At the time of the report, MENSTRUAL DISORDER (Issues with menstrual cycle.) had not resolved.            No concomitant medications reported.  No treatment medications reported.
Her vaccine was in the afternoon on 2/11. She had no adverse effects for the rest of the day. Today, 2/12, she woke up and did not know where she was and she could not speak in complete sentences. She was unable to dress herself or bath herself. This has persisted throughout the entire day. She has a temp of 101.5 F. She did likely have Covid (undiagnosed) in December and had the same symptoms for about one week. They had since resolved and she has had no other issues since then until today.
6.5cm area of erythema right lateral thigh skin tight/warm to touch. No drainage/nontender; Treated with Omnicef 125mg/5ml 5ml po qd x10 days
Flu Vaccine given, extreme soarness at site and swelling in armpit lasting 9 days
I had heart palpitations beginning within a week of getting the first dose. They would occasionally subside but were fairly constant. On December 26th I went to a walk-in to get an EKG and blood work done. The palpitations had been constant for about 24 hours and I was experiencing SOB without exertion. I also developed a rash on my left arm within 24 hours after receiving my second dose. This took about a week to resolve.
12 hours post injection experienced low grade fever (101F), nausea, full body aches, headache (light and noise sensitivity). Symptoms persisted for 24 hours and were controlled by ibprofen.
1 wk after vaccination mother noticed bruise at injection site, then red bump, then rash started spreading out over thigh. By May 29th rash had spread, and by June 10th rash spread to face. No fever, no illness no other symptoms. MD made Dermatology referral mom declined days it was from vaccine.
after approximately 20 hours the injection sight was bright red, hard and had a red rash surrounding it about 2" in diameter.  The upper arm was sore and lymph glands were swollen.  Over the course of the next week the redness, and heat spread to about 5" in diameter with significant heat coming off the site.  Arm soreness stopped after 4 days. Arm redness completely disappeared after 11 days.
Information has been received from a Nurse Practitioner, (N.P.), concerning a 2 year old male patient who on 10-DEC-2007 was vaccinated IM i "left arm" with a dose of PEDVAXHIB , 656519/0259U.  Two days post vaccination the patient was taken to the emergency room with left leg weakness, swelling, and left knee joint effusion.  CBC blood work tests were performed, white blood count was elevated, sedimentation rate elevated.  Also, blood work tests for Parvovirus B19, Streptococcus, and Lyme disease performed.  Result for Lyme disease was IGM negative, and IGG positive.  The child was not hospitalized.  He was scheduled for follow up with an orthopedic specialist the next day and treated with AMOXICILLIN and NAPROXEN.  The reporter stated the child's adverse event resolved by itself.  Additional information has been requested.
Patient had some slight bleeding at  injection site and then it swelled up to size of golf ball (looked to be blood filled). Applied ice to site and swelling decreased over next 30 minutes. Gave patient 2 IBUPROFEN (200 mg) to take at home.
Never got 3rd dose; got 1st dose Nov 2016, 2nd Jan 2017; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in Novemebr 2022).   In January 2017, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In January 2017, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: The reporter was a pharmacist. Patient received two doses of Twinrix. Patient never received third dose of Twinrix. The reporter did consent to follow up. No other information was available. The health care professional did not have time to provide further details of event. Additional supportive information: Patient received second dose of Twinrix late than recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix which led to incomplete course of vaccination. Note : As two schedule was provided for Twinrix conservatively too long event was coded as 2nd dose was reported as suspect.
I had a lesion appear which was determined to be  a reoccurrence of lymphoma - which required a stem cell transplant.
The pt experienced firm tender nodules (4-5) on scalp beginning on 4/2/00.
Immediately post vaccination pt reported dizziness.  Vitals: 84/51, 75, 17 Pt stable and released from the vaccination site.
Day of vaccination, around 8pm I developed a 102.5 degree fever, with chills and aches. took Ibuprofen 800mg. Fever broke around 11:30pm. next day fever and chills returned around 11:00am. I stayed in bed with flu like symptoms until 5:30pm. Then the fever and chills subsided. Today os Sunday and my arm is still pretty sore and warm to the touch.   With the fist vaccine, I only developed a large, red, sore spot on my arm.
Four days after vaccination I started to experience some pain on the left side when breathing, and it escalated the next day (April 5th) It became uncomfortable to take deep breaths. On April 7th I saw my PCP, and he ordered a chest x-ray and a covid test. Both tests were clear. The physician suggested it may be pleurisy. The pain continued, and I followed up with another physician in the practice on April 15th for an evaluation and blood work (D-dimer test). D-dimer test was clear. The pain started to resolve over the course of the next several days. Several months later I followed up with my allergist. She suggested my experience (symptoms and timeline) was consistent with myocarditis or pericarditis. She suggested a cardiac MRI to make sure there was no evidence of damage. I underwent a cardiac MRI on September 27, 2021 (approx. 6 months after the vaccine). The MRI did not show signs of damage.
patient given an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient given an expired vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.   This case was linked to MOD21-088361, MOD21-088351, MOD21-088359 (E2B Linked Report). This case was linked to MOD-2021-114420, MOD-2021-114641, MOD-2021-114834 (Patient Link).; Sender's Comments:  MOD21-088361: MOD21-088351: MOD21-088359:
Inj site red, bruised,warm x 3 days 1/6 pm raised,red  itchy, pain in arm and armpit, shoulder and back.  Narrative: 1/7 am went to EH, told to monitor area.
At 3pm, I was very nauseous and stayed that way for the rest of the night.  Upon waking the next morning, I woke up with a migraine that persisted for the next 6 days.  When waking on 11/25, my migraine was gone.  I have also experienced consistent fatigue since getting the dose that persists to this day.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The patient had allergy to Z-PAK. On 01-OCT-2014 the patient was vaccinated with one shot of PNEUMOVAX 23 (strength and route not reported), lot # J013555, expiration date: 02-MAY-2015, in the left deltoid. Concomitant therapies included a flu shot given in the right arm on 01-OCT-2014. On 02-OCT-2014 (also reported as unknown date), the patient experienced plum sized swelling 6 inches down from the injection site, redness and soreness. It was unknown if there was relevant lab data. As of 02-OCT-2014, it was unknown if the patient continued on PNEUMOVAX 23 and the swelling had gone down but the redness and soreness continued. Additional information has been requested.
9/20: diarrhea, sore joints, sore muscles, full body weakness (but still able to walk around house), chills. Injection site mildly swollen with 2.5 inch diameter pink area surrounding site. 9/21: symptoms resolving, still some swelling and pain in arm at injection site.
little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Asthmatic. Concomitant products included BUDESONIDE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), FORMOTEROL FUMARATE, HYDROCHLOROTHIAZIDE, MELOXICAM, PANTOPRAZOLE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LOSARTAN POTASSIUM, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PROBIOTICS NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little sore arm). At the time of the report, PAIN IN EXTREMITY (little sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Protein S: 1993 (abnormal) abnormal. On 27-Oct-2021, Protein S: 1019 (abnormal) abnormal. On 17-Jan-2022, Protein S: 197 (abnormal) abnormal.         Patient was tested for S and N proteins (probably talking about antibodies against those proteins). Patient was tested on 27Jul2021, then on 27Oct2021 and finally on 17Jan2022. S protein levels were 1993, 1019 and 197 for the 1st, 2nd and 3rd test, respectively. In all N protein level was 0.  No treatment medication was reported.   This case was linked to MOD-2022-455735, MOD-2022-455738 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Non-significant follow up
Low blood pressure; Nausea; I have not taken the second dose; Vertigo/ Extreme vertigo; Had a reaction to the first shot; Could not stand without assistance; Could not focus; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo/ Extreme vertigo), HYPOTENSION (Low blood pressure), VACCINATION COMPLICATION (Had a reaction to the first shot), DYSSTASIA (Could not stand without assistance) and DISTURBANCE IN ATTENTION (Could not focus) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VERTIGO (Vertigo/ Extreme vertigo), VACCINATION COMPLICATION (Had a reaction to the first shot), DYSSTASIA (Could not stand without assistance) and DISTURBANCE IN ATTENTION (Could not focus). On an unknown date, the patient experienced HYPOTENSION (Low blood pressure), NAUSEA (Nausea) and PRODUCT DOSE OMISSION ISSUE (I have not taken the second dose). At the time of the report, VERTIGO (Vertigo/ Extreme vertigo), HYPOTENSION (Low blood pressure), VACCINATION COMPLICATION (Had a reaction to the first shot), DYSSTASIA (Could not stand without assistance), DISTURBANCE IN ATTENTION (Could not focus), NAUSEA (Nausea) and PRODUCT DOSE OMISSION ISSUE (I have not taken the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Low blood pressure. On an unknown date, Heart rate: increased (High) Heartbeats increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given. Event  reported as The first day was severe on JAN-2021   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Event added could not stand without assistance, could not focus, The first day was severe.
Pt came back about 10 minutes after flu shot & wanted to know if swelling of lips could be an adverse event. I observed pt & a little portion of lip was swollen. He did not remember feeling it before the shot. I asked him to sit for 15-20 min to observe him. Nothing else happened. I offered BENADRYL & he took 1 tablet after sitting for 20 min. Asked pt to call me if anything else happened or he got worse.
Mother called reporting fever of 101 with chills and sever body aches and headache on the night after the vaccine was given. The fever and symptoms lasted for 2 days and then was gone.
This spontaneous report as received from a nurse refers to a18 year old patient. On 12-OCT-2013, the patient was vaccinated with PROQUAD, subcutaneous. Nurse reported that patient of 18 years age was administered PROQUAD (inappropriate age). No adverse effects were reported. This case is linked to 1312USA005814 and 1312USA006026 due to same reporter link. Additional information has been requested.
Fever reached 102.4 F. 12 hours after the injection and stayed elevated for 48 hrs. despite administration of ibuprofen (400 mg at 6 hour intervals) and fluids. Fatigue and headache for 72 hours. Swelling of upper left arm from shoulder to elbow. This was a repeat of events after dose two, except fever was a full degree higher and lasted on 36 hours.