chrisvoncsefalvay/vaers-outcomes huggingface dataset:
some allergies; body ache; a kind of sore throat but not that bad; feeling tired / fatigue; This is a spontaneous report received from a contactable consumer (patient reported for herself) from Pfizer sponsored program COVAX US Support A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration, on 18Mar2021 (at the age of 69-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had her first dose on 18Mar2021. Just this morning (01Apr2021), the patient had experienced body ache, a kind of sore throat but not that bad and feeling tired. The patient stated, it lasted for that short period of time, some allergies too that could be in the mix here. She had been fine since. Their next shot was on Thursday and knew they will be fine. Patient and her husband (age 73) both experienced fatigue the next day. They were relaxing. Patient wants to know if it was just side effects of the vaccine or if she was having a reaction to the vaccine. Outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I have pain in my left arm, shoulder and neck.  It hurts to touch parts of my left arm.  I also have tingling and numbness that radiates from the down my arm to my fingers and pain in the joint at the base of my thumb.
Rash/itching. Went own physician. Was given Prednisone & KEFLEX. Symptoms improving. On exam today (2/8/10), mild rash on chest noted. F/u with primary MD. Pt. did not report VAE until today to this facility.
patient had an injection site blister after her first dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of injection site blisters in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown.   It was unknown if the reporter considered the injection site blisters to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: The pharmacist had reported that the patient had an injection site blister after her first dose of Shingrix. Since, this was a chat therefore; the Healthcare Professional (HCP) did not have any vaccine information or lot and expiry date. The reporter consent to follow-up was not asked.
headache; fatigue; This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on an unknown date and experienced headache and fatigue, refer case US2022AMR094661).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache and fatigue were unknown.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.     Linked case(s) involving the same patient: US2022AMR094661   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The physician reported that patient received second dose of Shingrix and experienced headache and fatigue.   The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094661:Same patient, different dose
This spontaneous report was received from a physician assistant via a company representative and refers to a 12-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-AUG-2015, the patient was vaccinated with the first dose of GARDASIL intramuscularly, (dose, frequency, lot# and expiration date were not reported). On 02-MAY-2017, the patient was vaccinated with the second dose of GARDASIL intramuscularly, (dose, lot# and expiration date were not reported). On an unknown date, sometime after the first dose of the vaccine, the patient experienced muscle weakness, transverse mylasia and difficulty moving foot causing her to stumble and fall. It was reported that symptoms had worsened over the years period, on unknown dates. The events of muscle weakness, transverse mylasia and difficulty moving foot causing the patient to stumble and fall were reported as significant disability. The patient sought medical attention and was currently, at the time of this report, under a doctors care, she was given an unspecified treatment but she was not hospitalized. The outcome of muscle weakness, transverse mylasia and difficulty moving foot causing the patient to stumble and fall was not recovered at the time of this report. The relatedness between the events and GARDASIL was not reported. Upon internal review, the event of transverse mylasia was considered to be medically significant.
Pt exp nausea, vomiting, & diarrhea 1 wk p/receiving Influenva vax; On f/u, reporter states pt had gastrointestinal virus that was not related to Influenza virus;
Around 10:30pm I started to feel a pending headache, tired, feverish, chills, and nausea. Then around 11:30pm, I threw up mutile times from then until around 2:30am. Today, I feel bad stomach pains, nausea, tired and achy.
(R) arm huge/swollen x 5 days, 36 hours later felt joints very uncomfortable. "Felt like I wanted to jump of my body." Pt reported event: 11/9/11 at appt. with MD.
Suspected vaccination failure/I had the shot, get a mild case of Shingles a couple of years later; Mild case of Shingles (annoying ); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years 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 Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and had no side effects.  The patient did get a mild case of shingles a couple of years later.  The patient stated that annoying but nothing like you described. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
ringing in ears/presented with cricket sound and high pitch tinnitus in both ears; feels fatigued; left arm soreness that had improved; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist).  A 59 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Pollen allergy" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Dust allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1; lot number: unknown), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "ringing in ears/presented with cricket sound and high pitch tinnitus in both ears"; FATIGUE (non-serious) with onset 18Mar2021, outcome "not recovered", described as "feels fatigued"; PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "recovering", described as "left arm soreness that had improved". The events "ringing in ears/presented with cricket sound and high pitch tinnitus in both ears", "feels fatigued" and "left arm soreness that had improved" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus, fatigue, pain in extremity.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Clinical course: On 18Mar2021, after 3 hours of second dose, the patient experienced ringing in ears. The patient noted high pitched chirping in ears about 3 hours after receiving 2nd vaccine. It was reported that the patient presented with cricket sound and high pitch tinnitus in both ears. The patient did not experience hearing loss, dizziness or headache. The patient felt fatigued and had left arm soreness that had improved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had received a 025 ml dose of Fluzone IM on 2/09/07. Should have received 05 ml. Phone cell to dept of health advised repeat dose of .5 ml which was given on 2/20/07. Mother called 2/21/07 to report a lacey like rash developed about 7pm on arms, legs, buttock and noticed it on abdomen and back am 2/21/07. Child has a low grade fever, rash not raised, no other SX recommended Benadryl and Tylenol for age.
Patient received Influenza Vaccine Nov 17, 2008 and reported symptoms to office 11/21. Described redness and swelling on arm/injection site 24-72 hours post administration. By 11/21 symptoms resolved.
it was given in the same location as the HRIG; This case was reported by a pharmacist via licensee and described the occurrence of vaccine administered at inappropriate site in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included IMMUNOGLOBULIN HUMAN ANTI-RABIES (HRIG).   On 30th November 2020, the patient received RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On 30th November 2020, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the vaccine administered at inappropriate site 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 reported. The patient had a bite to the face. 3ml of Immunoglobulins were given at the site of the injury and 2ml were given in the deltoid. Then the Rabavert was given about 1 half 2 inch away from the HRIG injection site. Should the vaccine be given again if it was given in the same location as the HRIG.
Patient states that 1 hour after receiving her flu shot along with SHINGRIX shot she started experiencing sharp pain in her right arm which the same day became inflamed and red hot. Patient took TYLENOL to relieve pain since she is not allowed to take Ibuprofen. She also felt flu like symptoms next few days and severe inflammatory reaction lasted for about 1 week. She states that her inflammation is getting better with time and it is minimal when noticed by me today on 10/27/2018. Patient notified her primary doctor who has advised her not to take the second shot in SHINGRIX series.
After PPD placement, patient began to feel weak like she is going to pass out within 1-2 minutes. Began sweating and feeling shaky, appears pale. Made patient lay down with feet propped up, orange juice to drink, vital signs at 12:05 PM: pulse 72, blood pressure 92/58. Patient states that she is beginning to feel slightly better. Reports that she has had this happen before with injections. Vital signed repeated at 12:10; BP 100/58, pulse 77 and 12:20: BP: 104/78 pulse 82. Patient slowly sat patient up to sitting position, standing, and walking and patient reports that she feels "much better". Denies lightheadedness, dizzy, nausea, shaky. Her roommate/friend is on her way to pick her up due to advising her not to drive at this time. Walked patient out to waiting area to sit by PCT to wait for friend. Checked on patient again at 12:30 PM while sitting in waiting area and she reports full improvement of symptoms
Pt received injection on 4/26/00. Within a few days, redness at injection site was experienced. This progressed down arm to hand over the next few days. On 5/30/00 the pt went to ER to be examined. Pt went to family MD who tested blistered area on thumb. Pt is being treated with hydrocortisone cream and neurontin. Tests will take between 9-10 days. Spouse believes rash looks like shingles, but no diagnosis has been made. Annual 10/28/2003: "Attempted to contact by phone.  No answer.  Attempted to contact through attending MD.  MD has not patient on file by this name.  Called health department, stated patient has moved to WV and they have no forwarding info.  Conclusion:  Unable to locate patient for follow up info due to relocation."
COVID arm. Red, raised, itchy area around injection site, 8 days post vaccine dose #1.  Very sore arm as it was in the first few days of the injection.
24 hours after injection I began to develop a headache but didn?t think much of it b/c I have history of migraines and I was acutely aware that headaches were common after vaccines. I took excedrin and went about my day.  Took 2 more excedrin before going to bed and 41 hours after injection (and after a 2nd nights sleep) the headache was unbearable - I tried migraine medicine as well w/no relief. I am used to headaches and can manage them but this was different. The pressure inside my head felt like it was being inflated to the point of combustion and at times my scalp burned (along w/the injection site). I have a blood clotting disorder as well so I was monitoring vitals very closely.  My vision became compromised as well from the pain and pressure (it was def a vaccine induced migraine). I also developed a mucous producing cough which I noticed at about 41 hours as well.
Developed chills after 1st vaccine around 5 pm. Chills worsened over night and developed fever and achiness. Next morning still achy and fever. Fever broke the next morning. Symptoms lasted almost 15 hours. 10 days later, developed burning sensation on neck and side of back. Burning where shirt was touching and left arm which lasted one day.   2nd vaccine-Developed headache around 4-5 pm. Chills, fever, sweating over in the night. Yesterday fatigue, achy, and tired.
No other adverse event details available; incorrect product storage/vaccine had a temperature excursion of -13.3 degrees Celsius; This spontaneous report was received from a registered nurse concerning a 13-month-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 12-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter (ml) for prophylaxis, lot number T017688 and expiration date 21-MAY-2022 (strength, route of administration and anatomical site of vaccination were not provided). No additional adverse event (AE) details were available at the time of report..   The administered vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for 4 hours and 15 minutes on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion.  This is one of several reports received from the same reporter.
Fatigue; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included FINASTERIDE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.            Concomitant medications included High Blood Pressure Medication. No Treatment information provided   This case was linked to MOD-2021-076620 (Patient Link).
Started with back pain, possible kidney infection per urgent care. Went to ER multiple times for uncontrolled pain. During this time, blood pressure was extremely high and started to have difficulty urinating. Had several labs run, ultrasounds, CTs to determine possible cause of pain. On 2/10/12, PCP thought it was possible gall bladder problem, underwent HIDA scan, which indicated possible poor functioning of gall bladder causing pain.  Developed bilateral facial weakness, had gall bladder removed on 2/10/12. Starting 2/13/12-2/16/12 underwent several rounds of MRIs, had lumbar puncture. Final diagnosis of Guillain-Barre syndrome. Was hospitalized for IVIG treatment on 2/17/12-2/20/12.
Pt came to location for immunization. Verified pt name, DOB, and  allergies. Explained to pt what vaccines will be given. Pt verbalized  understanding. Vaccines administered. Pt tolerated the injections well. Pt  understood aftercare instructions for pain/fever.   Pt was observed and started to feel like vomiting. Pt was escorted to the nurse's  room by nurse who took over the situation.   BP: 109/59 | O2: 99% | P: 80 BP: 110/63 | O2: 99% | P: 80  Pt stated she felt better and was released back to class. School contacted parent  and explained the situation. Staff attempted to call the parent, but still  awaiting phone call back.
Tightness around the chest and up to the neck; there is some pain around her neck and chest area but it comes and goes; there is some pain around her neck and chest area but it comes and goes; Nausea; Chills; Fever; Leg pain; This is a spontaneous report from a contactable consumer (mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 28Apr2021 10:30 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient got Pfizer vaccine on 28Apr2021 10:30 and the night was rough, fever, chills, leg pain, nausea which were all pretty standard and today (on 29Apr2021), she complained about a tightness around her chest that comes and goes. On 29Apr2021, she had tightness around the chest and up to the neck. Outcome of the event tightness around the chest and up to the neck was unknown; pain around her neck and chest was not resolved; and rest all the events were resolved on 29Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age. The patients might have received VAQTA (Lot# unspecified) on a schedule other than what was in the prescribing information. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patients had sought medical attention. This is one of the reports from the same source. Additional information has been requested.
Soft tissue swelling at site of injection, no induration or itching so that upper arm was 1/2 inch bigger (R arm 7.75 inches around; L arm 8.25 inches around)
Information has been received from a physician concerning a 7 year old male with chronic renal insufficiency, asthma and allergic rhinitis reaction airways who on 13-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 657944/1003U). The patient was on certain medication for chronic renal insufficiency and asthma. It was reported that after vaccination the patient had an anaphylactic reaction and went to the ER and it was resolved within one day. Additional information has been requested.
Patchy redness over her cheeks, face, neck, chest and arms. Rx. Pediapred one tsp b.i.d. Benadryl 12.5/5ml 3/4 tsp 3 to 4 x's daily. Pt was presented to clinic on 8/13/05. She was screened as baby's mother was in attendance. The mother had previous records indicated that her baby received her first shots of Pediarix, Hib and PCV 7 on 3/14/05. Mother denied that baby had any problems or reactions after the first set of vaccinations. Mother also stated that the baby was well that day. It was a very warm day. It was noted that the baby was fussy and had a small amount of rash on her cheeks. Mother and baby are Hispanic so the mother needed help with interpretation. The screening and vaccination process went well. The mother and infant stayed so their WIC checks could be received. Within 5 minutes or so after the vaccinations, the mother showed the interpreter that her baby had a rash in axillary areas, on lower abdomen and posterior neck and knee areas. The interpreter notified the nurse. The baby did not have any evidence of breathing problems or distress. The mother was encouraged to take the infant to the local physician's clinic.
pt recv vax & was checked by RNP, pt was trembling but no temp; pt was taken home, slept & @ 6pm was taken to ER w/ temp of 105 degrees, temp treated w/ advil; 1am T102 degrees, advil was repeated. MD in ER said rxn was d/t vax
Myalgia, Arthralgia, Diarrhea, NauseaVomiting, lightheadedness Narrative:  Other Relevant History:
Hive spots on neck, went away, then hive spots appeared underarms and bottome off feet and have not disappeared