chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLUSHING; CLAMMY SKIN; JOINT PAIN; HEADACHE; FATIGUE; METALLIC TASTE; EXCRUCIATING PAIN BELOW THE WAIST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included 3 heart attacks, total hysterectomy, laparotomy, 2 stents placed, and neurostimulator placed in back. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left arm on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced excruciating pain below the waist. On 12-MAR-2021, the subject experienced metallic taste. On 13-MAR-2021, the subject experienced flushing. On 13-MAR-2021, the subject experienced clammy skin. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on MAR-2021, and fatigue on 14-MAR-2021, had not recovered from headache, joint pain, flushing, and clammy skin, and the outcome of excruciating pain below the waist was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
injection site extremely sore, knot at injection site, nausea, body aches, fever, headache, runny nose
Shaking; Muscle Aches; dizziness, and not being able to get out of bed; not being able to get out of bed; This case was reported by a nurse via call center representative and described the occurrence of tremor in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of tremor, Shingrix with an associated reaction of myalgia, Shingrix with an associated reaction of dizziness, Shingrix with an associated reaction of mobility decreased and Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date, refer case US2020AMR197707).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor, muscle pain, dizziness and mobility decreased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tremor, muscle pain and dizziness were recovered/resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the tremor, muscle pain, dizziness and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The nurse is also the patient. The age at vaccination was not reported. The patient was in her 60's but did not provide a date of birth.  The reporter did not provide a lot number or expiration date for the dose. The patient experienced shaking, muscle aches, dizziness and not being able to get out of bed 2nd dose of Shingrix. All events had completely resolved. The reporter consented to follow up. The follow up to the be directed at the reporter's home address.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197707:same patient, 2nd dose
This spontaneous report as received from a consumer, who is the mother of the patient, refers to a 12 year old female patient. Current conditions were not reported. The patient's medical history included fainting during her 5 year vaccinations, approximately in 2006 or 2007 (specific dates and products unknown). On 06-AUG-2014 the patient was vaccinated with GARDASIL (intramuscular injection, 1 single shot, strength, anatomical location, lot # and expiration date not reported). Other suspect therapies included hemophilus B conjugate vaccine (meningococcal protein conjugale) (manufacturer unknown) (intramuscular, formulation, dose, strength, lot# and expiration date not reported). Concomitant medications were not reported. The reporter informed that on 06-AUG-2013, the patient fainted with seizure like movements after being vaccinated with GARDASIL. The reporter also stated that minutes before, the patient was vaccinated with hemophilus B conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown). The patient sought medical attention, however, no treatment was given for the events. No laboratory diagnostics studies were performed. The patient recovered from the events on 06-AUG-2014. Causality assessment was not provided by the reporter. Additional information has been requested.
patient experienced severe pain on upper arm radiating to chest and neck. patient felt pain on her chest while breathing
Pain in Right Arm at injection site and muscle achiness lasted 3 1/2 days, severe headache lasting 2 days, fatigue, chills, nausea , nasal stuffiness and dizziness lasting one day. Discomfort in lymph nodes under right arm and slightly in right breast lasting 4 days.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 30-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 with expiry date: unspecified for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012629 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
Day after- on awaking (6:00am Tue-10/10/18) aches & muscle pain plus fever in afternoon, Next day full body rash & fever on & off< following day rash worse. Started to clear the following Monday/Tuesday. Stiff neck remains as of 10/26/18.
The patient received the vaccine in her left deltiod. Immediately following the vaccination, the patient stated that her body felt numb. She became sweaty and said she was having difficulty breathing. She fainted and then was responsive to ammonia inhalant. Due to her difficulty breathing, the paramedics were called and responded. Her blood pressure and oxygen levels were normal. The patient refused additional medical treatment. She remained in the pharmacy for about 45 minutes after her vaccine and said she felt better.
This vial had spent more than 30 days in the refrigerator; No adverse event; This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022), PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 vaccination. It was reported that patient had no allergies to medications, food, and other products. It was unknown if patient had been ever diagnosed with/ tested positive for COVID-19. Patient had no acute illnesses, chronic or long-standing health conditions at the time of vaccination and up to one month before. On 11-Jul-2022 at 11:47 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 15-Aug-2022 at 9:35 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 25 microgram. On 15-Aug-2022 at 9:35 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022), PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (This vial had spent more than 30 days in the refrigerator, and the 30 day BUD was 14AUG2022) and PRODUCT STORAGE ERROR (This vial had spent more than 30 days in the refrigerator). Patient was not taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies  at time of vaccination and/or at the time of the adverse event. Patient race was reported. Vial was initially stored in the refrigerator on 14JUL 2022 and vial did not undergo any temperature excursions. That vial had spent more than 30 days in the refrigerator and the 30 day BUD was 14 AUG 2022.  No reported symptoms. No additional doses, medications, or treatments had been administered at that time.
Itching rash started on stomach and rib cage then continued to lower back then between breasts and right neck area.  Nothing on arms, legs or face.  1 week and 4 days later still rash and itching.  Prescribed 25 mg hydroxyzine 3 times a day on March 5  and topical calamine.  Seems to be getting better with occasional itching.  I HAVE PICTURES, but no place to upload.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details include acetaminophen and that helps some
30Y/O male c/o numbness/sensitivity in both hands and feet, loss of balance and increased weakness in both arms, Headache and neck pain
I was exposed on 12/26/2022, at a holiday party. I tested at home on 01/02/2022. on 12/31/2022, I felt off and tired. I went to bed early and on the 1st, I felt okay, I had sneezing and a little of a runny nose I tested at home, and it was negative. On the 2nd I decided to test, and it was positive. I contacted telehealth and was prescribed Paxlovid, the symptoms were fine by the 3rd. I felt fine and tested on 01/09/2023 it was negative.
no additional AEs; HCP called in and reported that improperly stored vaccines, PEDVAX HIB and ROTATEQ were administered. No further information was provided. See additional AEs reported in cases #02229849, #022; This spontaneous report was received from a registered nurse and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 18-AUG-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U031543 was determined to be valid, expiration date: 23-JUN-2024 (dose, vaccination schedule, site and route of administration were not provided), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1879873 was determined to be valid, expiration date: 12-NOV-2023, administered orally (dose and vaccination schedule were not provided), both for prophylaxis. No additional adverse events were reported.  This is one of several reports received from the same reporter.
On Wednesday, January 20, 2021 a red spot appeared near the injection site. I provided a picture of my left shoulder in the email i sent on 01/22/2020.The site is not itchy, there are no bumps and it is not hot to the touch. I have not experienced any other side effect.
imz is supposed to be SQ, i administered IM, that is what i'm reporting. pt reports no adverse effects.
MULTI SYSTEMS FAILURE, TRAUMATIC SUBDURAL HEMATOMA Death on 9/6/2021
My husband had the shot and he got shingles/ Suspect vaccination failure; My husband had the shot and he got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The reporter stated that her husband had the shingles shot and he got shingles. The reporter stated that the shot does not always stop from getting shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Severe swelling- inflammation of eye area. I received the booster on 12.4.21. I have have had three flare ups post injection. My MD has treated with steroids and ran multiple blood tests. The blood tests came back abnormal with high levels for auto immune deficiency - lupus and or Sojourns' syndrome which I have never had before. I have been referred to a rheumatologist but my appointment is not until 4.6.22. I am under the care of my internist currently and managing symptoms of inflammation, impaired vision, and fatigue.
Patient became stiff and verbally unresponsive, glassy eyes and eyes rolled back in head.  Heavy breathing and tachycardia.  Vital signs checked, oximeter check, monitored status, called EMS and transport to hospital.
I was inoculated in the upper left arm. I felt the normal pain that comes with the booster as this is my 10th but as the day went on a pain started shooting through my arm pit and down my left leg into my knee that would start twitching. By the evening I was dizzy and extremely tired so I tried to sleep but the body aches got worse. By noon the next day the aches on my left hurt so bad that it slowed me down considerably and then the pain in my back and neck along with the headache became too much so I was escorted to the ER where I was given codeine to help with the pain and was told that it will pass and there is nothing that can be done. In 2003 I had a similar reaction while at work that no one could explain. I wasn't sick but had a temp of 105.8 and was completely delirious, the body aches and pain that I had this time were just like the ones I experienced before. Those lasted for 7 days. I was told it was a miracle I lived considering the conditions.
101.9 degree fever, sweats, headache, diarrhea. This occurred within 24-48 hours after the shot was administered; however, the effects diminished after 48 hours.
Swollen arm from shoulder to elbow pain and hot to touch can't lift left arm without pain steroid shot 10/9/18.
Came to HD for H1N1 vaccine, IM given. Client went to her truck & came back into health dept. SOB with audible wheezing with whistling. 911 called. Taken she walked to clinic room with O2 applied- Epi given.  12/22/09 Hospital ER records received for DOS 11/18/09. Dx: Allergic reaction, Asthma with acute exacerbation precipitated by vac. Patient at local health dept and received H1N1 and after injection c/o SOB and wheezing. Received epie injection. Presented with shortness of breath, wheezing, headache with blurred vision, photophobia and nausea. Treated with dexamethasone, diphenhydramine, ketorolac, promethazine, budesonide nebulizer susp. and albuterol-ipratropium. Discharged.
pain, head, neck, ears, shoulders, chest, back, hips, knees, feet
Narrative:  Patient admitted to Medicine team for COVID pneumonia, off supplemental O2. concern for cardiac instability, confirmed 1st degree AV block with intermittent 2nd degree Mobitz I AV block which was new for the patient, transferred to medical step down unit. In the MSDU the patient was comfortable on room air with his only symptom being a cough. He did not have any chest pain/pressure, shortness of breath, lightheadedness/presyncope, or other concerning symptoms. Patient had intermittent bradycardia with baseline 1st degree AV block and intermittent 2nd degree Mobitz I AV block. Checked TSH given cardiac arrhythmia in patient with hypothyroidism however this was normal. Medication list reviewed, not on AV nodal agents, no electrolyte abnormalities. Patient not on supplemental O2 so did not use dexamethasone, remdesivir. Given no signs of high-grade block, patient discharged to home. After discussion patient noted he would prefer to come back tomorrow to have Holter/event. Will follow-up with Cardiology as outpatient. Will also follow with PCP and have both skilled & non-skilled home health services.
Tiredness, elevated temp, achiness to shoulders bilaterally x 2 days. Temp 99.
Feeling ill progressively worsening throughout day so missed work overnite shift - muscle ache all over, progressive tiredness, swollen joints 2 days lost work
Approximately 10-15 min. following administration, pt. ret'd to the pharmacy disorientated. Pt. was profusely sweating; he complained of lightheadedness, dizziness, loss of vision and pounding headache. Pt. rec'd after resting for 20-30 min; with headache and weakness still remaining.
had the flu; Initial information received on 12-Dec-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).  This case involved a patient with unknown demographics who experienced had the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
inadvertently administrated frozen / vaccines; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In June 2021, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Menveo and Havrix. In January 2021, the patient started Havrix Pre-Filled Syringe Device. In June 2021, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Havrix, Havrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The doctor reported that, there was a glitch in the thermometer and believed that a temperature excursion did not happen. In June 2021, the frozen vaccines of Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix and Infanrix was administered to several patients, which led to incorrect storage of drug.  The vaccines were exposed to below temperature 11.7 Fahrenheit. No details of patients were available. The reporter consented to follow up.
Woke up with strong headache, which is very unusual for patient.  Headache lasted all day and was not eased with ibuprofen.  Headache was accompanied with tiredness and lack of energy.  Headache present at bedtime at 9:30 pm.  Headache gone the next morning.
multiple pts recvd 2 or 3 doses of Engerix-B & p/inject had pain in the arm; resolved in 1 wk;
About 1 HR after, trouble breathing, rapid heartbeat, weakness, nausea, swollen injection site, dizzy & couldn't focus
Approximately 15:00, mother reported baby crying frequent and crying anytime not held. Pt. was checked by doctor and states elevated pulse. Recommended taking her to ER to be checked out. Father states he will take baby to ER. Pediatrician will take baby to TMC.
Child received vaccination/was anxious but mother was present; 12 min after administration became diaphoretic/pale - no issues w/ breathing etc. Mom states child frequently gets hypoglycemic and is lactose intolerant - orange juice given. Child recovered within 5 min and returned to class - recall to school at 2:30 PM - child is "fine now".
Severe HA, muscle weakness, lethargy, no appetite, achy, pain, fever.
Pt reported that she had muscle aches for 5 days after then developed a rash after she had chills, fever day 6
a week after receiving the vaccine,  I developed shortness of breath and a dry cough. it has been over 2 months with the shortness of breath and coughing  without improvement