chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflamation; High spike protein; Migraines daily; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6204, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 13Apr2021, when the patient was 55-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: ER 8732, Location of injection: Leg Left, Vaccine Administration Time: 04:30 PM), administration date: 23Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Location of injection: Leg Left". The following information was reported: PROTEIN S INCREASED (non-serious) with onset 07Jun2023 at 15:30, outcome "recovered", described as "High spike protein"; INFLAMMATION (non-serious) with onset 07Jun2023 at 15:30, outcome "recovered", described as "Inflamation"; MIGRAINE (non-serious) with onset 07Jun2023 at 15:30, outcome "recovered", described as "Migraines daily". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of inflammation, protein s increased, migraine.  Additional Information: It was reported that the patient did not take any other vaccine or any other medication in four weeks . The patient was not diagnosed with covid prior to vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
She got her vaccine, and on the 2nd day her hand started hurting.  All 8 digits of her hand trigger finger, which she had surgery on before.  She could not touch anything, hold a coffee cup, pull her pants up or peel potatoes.  Then as it went on it went to her left shoulder and she couldn't lift her arm.  It hurt down from the bone in the top of her shoulder, down to about her elbow, and it's like muscle pain.  It then traveled across into her left shoulder blade and went across both of them.  She could not find a way to lay down and sleep.  It then went down the right arm, and down to the base of her back.  She is not able to lift her arm without the help of her other arm.  Her hands are sore, and it's been over 2 months and wonders if this is going to go away or is she left with this the rest of her life.  Some fingers still pop, and has to pop her fingers loose by popping it as it was triggering.  Some days she has a pretty good day and the other is hurts like crazy.    She said that she doesn't think that she would get another booster.     She went to her cardiologist and he said his wife had AE from the Moderna vaccination.   She then went to her diabetic doctor and the NP is in her 40s and said that she got her booster and she had similar complaints and said that she thought she was going to die the pain was so bad.  She went to her PCP and told her take Tylenol.    It bothers her more at night, and wakes her up in the middle of the night.  She has pain almost every day.
pt recv vax; devel redness & swelling at inject site 10 days later;
Tetanus booster given in left deltoid on 08/06/2004. Pt called8/5/04 with complaints of red, hot swollen left upper arm. Advised Tylenol or Motrin, cool compress, OTC Benadryl. Call if worsening with 3-4 doses of Benadryl.
This initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were inadvertently vaccinated with improperly stored MMR II injection (Dose, lot number, albumin status and route not provided). A total of 39 doses were administered. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
throat thickening; weird taste; elevated blood pressure(185/90); This spontaneous case was reported by a pharmacist and describes the occurrence of THROAT TIGHTNESS (throat thickening), DYSGEUSIA (weird taste) and BLOOD PRESSURE INCREASED (elevated blood pressure(185/90)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced THROAT TIGHTNESS (throat thickening), DYSGEUSIA (weird taste) and BLOOD PRESSURE INCREASED (elevated blood pressure(185/90)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Mar-2021 at a dose of 12.5 mg. On 03-Mar-2021, THROAT TIGHTNESS (throat thickening), DYSGEUSIA (weird taste) and BLOOD PRESSURE INCREASED (elevated blood pressure(185/90)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: 185/90 hg/mm (High) 185/90 hg/mm and 130/90 hg/mm (High) 130/90 hg/mm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Extremely painful shot compared with first two. Started having overall body aches and severe headache and neck pain., feel like having meningitis  that lasted for 3 days. It didn?t response to Advil, and Tylenol doesn?t work for me. Feeling lethargic, skin is painful to touch. One week on, after took a nap, woke up with body rash(red spots) all over my trunk and thigh areas. Took hydrocortisone cream and Zyrtec.
Pt reported local rash reaction at injection site on left arm which was red in color, baseball size diameter, tender, and painful. Verified no body aches, no fever, or other symptoms. Symptoms first noticed the morning after getting vaccine. Pt has reported it hasn't gotten better since. RPh counselled to monitor site and use OTC ibuprofen for pain relief as well as local ice pack at site if needed.
PAIN IN EYE; DRY EYE; HEADACHE; This spontaneous report received from a patient concerned a 63 year old female. 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced pain in eye, dry eye, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in eye, headache and dry eye was not reported. This report was non-serious.
Has had fever since evening 14MAR93 was 105 99.8 oral now 16MAR 345PM arm lt red & swollen 4" x 2 1/2" area (upper arm-shoulder);
Received immunization on 9/9/02. No fever. Injection site is ok. Baby very fussy and cranky.
Fever, chills, muscle aches, fatigue, soreness and lump at injection site.
Feb 11 - Had vaccine, had not been ill in months. Feb 12 - Passed out in the bathroom when I got up that morning. Low blood pressure. Feb 15 - Sudden onset headache with visual disturbance. Left thumb and forefinger went completely numb for a few minutes. Entire episode lasted about 30 minutes. Feb 17 - Another sudden headache with some visual disturbance. Feb 19 - Sudden intense headache, visual disturbance, confusion, speech problem, pain behind left eye. Did not let up. After 2 hours, went to ER, stayed overnight to determine if stroke symptoms.
High fever, lethargy, uncontrolled crying for short periods of time. See attached hospital records.  5/9/08 Reviewed hospital medical records of 2/28-3/3/2008. FINAL DX: atypical Kawasaki's disease w/o evidence of cardiac lesions Records reveal patient expereinced febrile illness x 7 days w/URI s/s, pale, rash, conjunctivitis, acute OM, emesis, fall, irritability, poor appetite, red lips, swelling of hands/feet w/peeling skin on feet.  Cardiology consult done.  Tx w/IVIG & ASA.  Improved & d/c to home on continued ASA w/cardio f/u & serial echocardiograms.   3/11/08 Reviewed ER medical records of 2/21/08. FINAL DX: possible viral syndrome; r/o Kawasaki disease; & prolonged fever.  Records reveal patient w/fever day s/p vaccines w/fall that day hitting back of head & becoming sleepy.  Returned to ER on 2/22/08 for continued fever, cough, post tussive emesis & irritability.  Temp in ER was 103.1  Sick sibling in home.  TX w/IV antibiotics & antipyretics.  Dx at that time Fever & URI on continued oral antibiotics. No improvement & admitted  2/23-2/28/2008.  Hospital medical records reveal patient experienced cold s/s of low grade fever, cough, runny nose, respiratory congestion, wheezing, intercostal retractions x 2 days.  Seen by PCP & sent to ER.  Temp in ER was 104.  Tx w/breathing treatments & IV antibiotics.  Developed diffuse urticarial rash & inflammed conjunctiva.  Continued to run fever as high as 106.  Transferred to higher level of care. Linked w/307191 Follow-up: Telephone and registered mail attempts to communicate for follow-up have been unsuccessful.
Swelling, redness, bumps, itchiness, and skin hardening in a 3 inch diameter around injection site about a week after injection.
On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022; No adverse event; Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Unspecified COVID-19 Vaccine, Dose 1), COVID-19 VACCINE (Unspecified COVID-19 Vaccine, Booster Dose 1), COVID-19 VACCINE (Unspecified COVID-19 Vaccine and Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 06-Sep-2022 at 3:18 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Sep-2022 at 3:18 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine (Monovalent) to 27 patients.) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administred on 06-Sep-2022).    No concomitant medication was reported. On 18-Apr-2022 the vial was delivered and stored in the refrigerator on same date. The vial size is of 5.5mL. The vial did not undergo any temperature excursions. Vaccines were only offered on Tuesdays from March-2022 forward to the patient. For each Tuesday vaccine date, only removed one vial from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). No treatment information was reported.
We have had some problems with the prefilled syringes, difficulty with the plunger; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger) and NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for DEVICE ISSUE (We have had some problems with the prefilled syringes, difficulty with the plunger).    No concomitant or treatment medications were provided. The pharmacist reported that there was some problems with the prefilled syringes, difficulty with the plunger. The Device problem code for Spikevax syringe include FDA code 2588, IMDRF code A0203 which include Defective Device. The device was malfunctioned, and the malfunction type was CIRM.
Report described sore skin (arms) in a 60 year old vacinee who received hep A vaccine. This report was received from the vaccinee and has not been verified by a physician or other health care professional. The vaccinee denied medical history and allergies. She received progesterone and acetaminophen as needed. On 09/03/1999, the vaccinee received her first dose of hep A vaccine without adverse event. On 03/26/2001, the vaccinee received the second dose of hep A vaccine. On 03/27/2001, the vaccinee reportedly experienced sore skin in her armpits extending 2-4 inches down her arms. She reportedly discontinued deoderants "without success." As of 07/11/2001, the event was unresolved.
Pt recvd vax & pt exp local blistering, swelling, lumpiness, & rash;
24 hours after vaccine patient had body aches, fever, chills which lasted 36 hours and then went away completely. Then on 3/18/21 patient developed bilateral hip pain, knee pain, ankle pain. Treated with prednisone 40 mg, taper by 10 mg every three days
Patient fainted in waiting area less than five minutes after receiving Gardasil injection. Patient disoriented and c/o difficulty breathing when roused. C/O nausea, dizziness. Sent to ER & diagnosed as vasovagal syncope. Patient c/o sores in genital area 3 days post vaccination. Upon visit to doctor, diagnosed with Condyloma.
staff stated left arm  was itchy, little rash, redness the size of 50 cent coin
Body aches; Upset stomach; Chills; Head felt foggy; Arm got really sore; This is a spontaneous report received from a Pfizer sponsored program  via medical information team. A contactable consumer (patient's parent) reported for a male patient (reporter's son) of unspecified age that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date: not reported) via an unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that on 24Apr2021, the next day, the patients arm got really sore. But on 25Apr2021, he had body aches, upset stomach, a little bit of chills and head felt foggy. On 26Apr2021, today he did not have the chills and enquired if there was something they did for it. He was not running a fever at that time and asked how long do these side effects last. Patient had experienced a lot of side effects and wanted to know if it was common to experience those side effects. It was unknown if the reporter was a healthcare professional and contact information was available. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. No unaddressed medical questions were referred or forwarded to Medical Information. Outcome was recovered for chills on 26Apr2021 and unknown for all the other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
53 year old female with history of hypertension, reactive airway disease presenting for evaluation of rash for the past 2 days.  Patient reports that she has had a rash to her inner thighs/groin, arms, abdomen, back of legs for the past 2 days.  Reports that she has triamcinolone cream at home which she has tried with minimal improvement.  Reports that she also took benadryl a few times yesterday which helped but the rash is still very itchy.  Denies any fevers/chills.  Reports has history of rashes as she has sensitive skin but nothing this bad.  Denies any facial swelling, lip or tongue swelling, difficulty swallowing, chest pain or shortness of breath.  Patient denies any new foods, detergents, creams, lotions, medications, exposures.  Patient reports she originally had her second Pfizer vaccine scheduled for today but rescheduled for Saturday as she wanted to make sure it was still okay for her to get it with this rash.  Reports had her first dose on 3/24/21 and only had a local rash around the vaccine site.  Patient is a 53 y.o. female with history of sensitive skin and occasional urticaria presenting with 2 week history of severe urticaria not responsive to antihistamines or prednisone.    Received 1st dose of Pfizer COVID-19 vaccine on March 24 Hives started around April 11th   She normally gets transient hives because she has very sensitive skin She was not worried at first, but these hives persisted for longer than usual 2-3 hours. Started in inner thighs near inguinal folds Migrated to different areas including face/eyes, calves, hips, thighs, and back Hives were horrible; very large and "angry"    Went to urgent care on April 14th  Held off on getting second COVID vaccine dose  Prednisone 40 mg x4 days which did nothing No change after stopping prednisone  Also tried hydroxyzine, did not like how it made her feel   Reports severe heart burn and anxiety as well Onset was around same time as hives  She was advised to go to ER on 4/19 due to progression of hives to face, some lip swelling, and throat feeling "funny". Went to the ER where she was evaluated in the waiting area due to overcrowding and was advised that she could leave as she was not in immediate danger.   Finally evaluated by dermatology on 4/22, who agreed her rash was "angry hives", and started on triamcinolone cream as well as 4 zyrtec/day, Pepcid. Symptoms improved around day 3 of triamcinolone cream  Last night was first night that hives were not terrible but did have 2 flare ups today    History of sensitive skin She cannot use perfumes or scented products  Uses detergents and soaps without fragrance or dyes.   Has had intermittent mild hives over 10-15 years  Never had flare 2/2 infection    She has not notice any other triggers for hives.  Often had hives with no identified trigger. In the past, hives improved with benadryl  These hives did not respond to benadryl   1st dose of Pfizer COVID 19 vaccine 03/24/21  Went to bed early, a little bit aching, then felt better in 1.5 days
Information has been received from a nurse practitioner (N.P.) concerning an approximately 19 year old female with no known drug allergies who on 09-DEC-2006 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 653938/0954F). On 03-MAR-2007 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 655503/0012U). On 06-JUL-2007 the patient was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 658094/0524U). The patient claimed that she was not sexually active prior to the completion of the GARDASIL vaccine (yeast) series. On an unspecified date the patient tested positive for "low grade squamous intraepithelial lesion for SIN 1". The patient was recovering from the symptoms. The patient was seen by the nurse practitioner to seek unspecified medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/15/2008. Follow up information was received from a physician. It was reported that the patient received the first dose of GARDASIL vaccine in the right upper deltoid and received second and third dose in the left upper deltoid. The patient was on birth control (unspecified). The patient was diagnosed with low grade squamous intraepithelial lesion (low-grade LSIL). Additional information has been requested.
Extreme body pains/aches; Nausea; Headache; Chills; fever; body aching is severe/every symptom intensified at once; This is a spontaneous report from a contactable consumer (Patient). A 63-years-old female patient received first dose of BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:00 (At the age of 63 years old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 10Sep2020 to an unknown date. Reporter had COVID back in Sep2020. Reporter was diagnosed on 10Sep2020 and ended up with Pneumonia on 23Sep2020 to an unknown date. The patient's concomitant medications were not reported. Other products, patient history and Investigation assessment was not provided. Patient took COVID Vaccine because she had travelled in Mar2021 which means she was exposed more. On 09Feb2021 the patient experienced extreme body pains/aches, nausea, headache, chills, fever and on Feb2021 Patient experienced body aching is severe/every symptom intensified at once. Reporter was unsure if she had a fever. Reporter had not taken her temperature. But the body aching was severe. Reporter confirmed she knew these feelings as they were the same as when she had COVID. Only now it was every symptom intensified at once. With COVID you had them spread out over 2 weeks. Reporter just needs some relief. She was so sick. She did not think she would get like this. Reporter thought maybe she got the vaccine too soon after she had COVID. Reporter just finished off the bottle of Ibuprofen, which was in fact the brand name Advil. LOT R41362, EXP: Sep2019. Therapeutic measures were taken as a result of extreme body pains/aches (pain) with Ibuprofen and Tylenol. Ibuprofen and Tylenol do not seem to do much. Reporter did not realize it was old. The Tylenol was actually a generic. Costco's generic brand, Kirkland's Extra Strength Acetaminophen. LOT: 0GV1265, EXP: May2022. Reporter had some Hydrocodone-Acetaminophen left over, could she take one of those to knock her out so she can sleep. The outcome of the events extreme body pains/aches, nausea, headache, and chills was not recovered, and outcome of the event fever and body aching is severe/every symptom intensified at once was unknown   Follow-up attempts are completed. No further information is expected.