chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold; If lay on left or right it hurts; Tongue hasn't been too bad, last time my tongue was swollen; Every night is lousy; Tired; Right hand side hurts like hell; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen) and FEELING ABNORMAL (Every night is lousy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product SUNITINIB MALATE (SUTENT) for an unknown indication.    Concurrent medical conditions included Abnormal platelets (platelets up and down). Concomitant products included VITAMINS NOS for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and SUNITINIB MALATE (SUTENT) (unknown route) 37.5 mg. On an unknown date, the patient experienced FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen), FEELING ABNORMAL (Every night is lousy) and FATIGUE (Tired). At the time of the report, FEELING COLD (Cold), VACCINATION SITE PAIN (Right hand side hurts like hell), PAIN (If lay on left or right it hurts), TONGUE DISCOMFORT (Tongue hasn't been too bad, last time my tongue was swollen), FEELING ABNORMAL (Every night is lousy) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) blood tests are going good.         Concomitantly patient was also taking flaxseed  for abnormal platelets until he stopped them recently.  Treatment information was not provided.  Action taken with mRNA-1273 in response to events was not applicable.
the evening p/vax approx 8PM pt began screaming, excessive slobbering, face swollen, eyes red, began throwing head back against car seat-episode passed; pt was fine by 930-10PM; next day pt was quote normal self
feeling off; very foggy; thoughts were cloudy; feeling off; very foggy; thoughts were cloudy; feeling off; very foggy; thoughts were cloudy; thought process feels sluggish; kinda feels a dreamlike; thought process feels sluggish; kinda feels a dreamlike; soreness in the arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the first episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the second episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), BRADYPHRENIA (thought process feels sluggish; kinda feels a dreamlike) and DREAMY STATE (thought process feels sluggish; kinda feels a dreamlike) in a 30-year-old female patient 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THINKING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the first episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the second episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), BRADYPHRENIA (thought process feels sluggish; kinda feels a dreamlike), DREAMY STATE (thought process feels sluggish; kinda feels a dreamlike) and VACCINATION SITE PAIN (soreness in the arm after second dose). The patient was treated with PARACETAMOL (TYLENOL) for Foggy feeling in head, at an unspecified dose and frequency. At the time of the report, THINKING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the last episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), BRADYPHRENIA (thought process feels sluggish; kinda feels a dreamlike), DREAMY STATE (thought process feels sluggish; kinda feels a dreamlike) and VACCINATION SITE PAIN (soreness in the arm after second dose) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were provided.
Second dose schedualed >36 after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 after the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedualed >36 after the first dose) had resolved. 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up was received on 27 May 2021 included no new information.
Patient received vaccines on 8/29/17, and patient called to report muscle aching pain during movement and swollen at the injection site on 8/31/17. Patient was advised to apply cold compression at the injection area and return to see primary care provider if symptom worsen or not improved. Patient then was being seen at PCP office on 9/6/17 because patient complaining of her arm has been hurting since last week when she received her vaccines. Patient states her arm was swollen, bruised, and a bump. Per patient, her left arm is still painful and her right arm is not painful anymore. General inspection on 9/6/17: Right deltoid - 1cm bruise, Left deltoid mild tender to palpation, no cellulitis on both arm. Patient was recommended to try MOTRIN if desired and was reassured symptom should continue to improve.
Red rash from stomach all the way up to armpits - looks like sunburn all over.
Information has been received from a nurse concerning a 17 year old female patient who on 22-JUN-2007, was vaccinated with a first dose of Gardasil. Immediately, the patient was dizzy and light-headed. Unspecified medical attention was sought. After several minutes the patient recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 07/16/2007. Information has been received from a nurse concerning a 17 year old female patient who on 22-JUN-2007, was vaccinated with a first dose of GARDASIL. Immediately, the patient was dizzy and light-headed. Unspecified medical attention was sought. After several minutes the patient recovered. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 53 year old female patient with a medical history of cancer and no known drug reactions/allergies, who on 30-OCT-2008 was vaccinated with PNEUMOVAX 23 (Lot. 660717/0224X), 0.5ml, intramuscularly and experienced cellulitis in the arm of administration. At the time this report, the patient was recovering. The patient sought medical attention and was seen at the practice office. This is one of several reports from the same source. Additional information has been requested.
Extreme rash and itch on arms and chest; Extreme rash and itch on arms and chest; Raised bumps that are symmetrical on body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 27Sep2022 as unk unk, single; EZETIMIBE; ROSUVASTATIN; BABY ASPIRIN. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Pfizer "Purple Cap"; lot number: FH8028; vaccine location: Right arm), administration date: 19Nov2021, when the patient was 71-year-old, for Covid-19 Immunisation; BNT162b2 (DOSE 2, SINGLE; Pfizer "Purple Cap"; lot number: EN6203; vaccine location: Left arm), administration date: 16Mar2021, when the patient was 70-year-old, for Covid-19 Immunisation; BNT162b2 (DOSE 1, SINGLE; Pfizer "Purple Cap"; lot number: EN0201; vaccine location: Left arm), administration date: 23Feb2021, when the patient was 70-year-old, for Covid-19 Immunisation. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 19Oct2022, outcome "not recovered" and all described as "Extreme rash and itch on arms and chest"; PAPULE (non-serious) with onset 19Oct2022, outcome "not recovered", described as "Raised bumps that are symmetrical on body". The events "extreme rash and itch on arms and chest" and "raised bumps that are symmetrical on body" required physician office visit. Therapeutic measures were taken as a result of rash, pruritus, papule.  Additional information: Patient received OTC Antihistamine, Prednasone 20 mg-ordered twice for events. Patient also received Pfizer Bivalent Sars-cov-2 Vaccine Booster 12+ Yrs (Lot number: GJ2524) on 25Oct2022 as dose 5 at right arm for covid-19 immunisation.
Initial unsolicited report received from Consumer via partner company (Pfizer) on 25-Nov-2015. This case involves a 81-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (INFLUENZA VACCINE) (batch number was unknown, expiry date and route of administration were not reported) in left arm and with a dose of PNEUMOCOCCAL POLYSACCHARIDE VACCINE (Prevnar 13) (manufacturer: Pfizer, batch number was not available, expiry date and route of administration were not reported) in right arm on 28-Oct-2015 sometime after 14:30 hours. It was reported that patient had no illness at the time of vaccination. Medical history and concomitant medications were not reported. Patient had not reported this adverse event previously. On unspecified date after vaccination, patient had experienced limitation of right arm movement, muscle pain and joint pain. Patient reported that side effects did not start on the same day that she received the vaccine. Patient did not require an emergency doctor visit. No Lab test had been performed and corrective treatments were not reported. At the time of report, events were still persisting (ongoing) and patient was not recovered from the events. Documents held by sender: none. Follow up information received from Consumer in on 21 January 2016. The event coding was updated from limited movement to injected limb mobility decreased. No additional information provided.
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date in approximately June 2012 (reported as a year and half ago), the patient was vaccinated with GARDASIL dose 1. The patient had received the second dose approximately in June 2013, reported as a year after the first. Dose, lot and expiry date were not reported for both doses. The physician stated that the patient has not reported any adverse effects. Additional information has been requested.
Guillan-Barre Syndrome - with slow neurologic recovery.  Residual deficits include significant generalized weakness, dysphagia and dysphonia, trach dependent and PEG tube dependent.  Also with urinary retention and poor rectal tone requiring intermittent disimpaction.  Continue supportive care including PT/OT, indwelling Foley catheter and daily disimpaction/stool softeners as needed.  Fortunately, patient has had some evidence of minor improvement (evidence of flexion extension of the right arm and flexion of the right wrist). Transferring from our facility Hospital today 7/14/21.  Accepting physician.
Presented to ER on 10/17/19 with complaints of right arm pain, swelling, and itching with onset 3 days after receipt of vaccination.  Patient was scratching injection site at night and using rubbing alcohol to help.  Patient stated arm pain was at injection site only.  Patient denied allergy to eggs, latex, shellfish, or citrus.  Prescribed oral hydroxyzine for itching, mupirocin topical for any infection, and non-pharmacologic RICE (rest, ice, compression, elevation).  Instructed to f/u with primary care provider in 1-2 weeks or return to ER if symptoms worsen.
Right after the vaccination I got headaches and then my arm had swollen lymph nodes. It was way worst and still is there. I contacted my doctor and they got a CAT scan done and everyday was normal. My blood work got back normal as well no explanation at all but the lymphs are still there.
Pt given whole milk and cheese for first time between 10-10:30 Pt developed "ear scratching" and hives around 1pm; call to office and advised to bring pt back to be evaluated Pt arrived at 1345 to office with full body rash and vomited Epi 0.15mL given IM; O2 via mask given; 911 called Pt transported to Hospital  ED Impression: Anaphylactic Reaction to Food, probably dairy-milk/cheese Epi Pen prescribed to pt
15 minutes after her vaccination, she started having itching and slight rash. She was given a dose of benadryl and observed for 45 minutes total.
Had vaccine done 04/11, By 4/13 started with a small area of redness, nodule grew in color and size with tenderness. No fever. PE: 3x3 cm mass with a 1.5 cm area of 3+ redness entire mass area very tender, firm, TX: heat and augmentin.
Felt fine at the time of the vaccine.  Later in the evening, arm a little sore.  Starting at 3:30am, cold sweats.  An hour later, hot sweats and fever.  3 hours later, vomiting and diarrhea.   Headache and slept another 4 hours, totaling 13 hours (not normal).  Felt better after sleeping.
Elevated temperature 103.5 degrees.  Extreme muscle weakness.  Seen in ER, will also be evaluated by physician at his family practice.
Dizzy slept for 3 days, vomiting, swelling of throat very inflamed, chills, fever and diarrhea. Throat still has lumps in it. Very tender. A week later. Have pictures of symptoms.
an expired VAQTA was given to a patient; No AEs were reported; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) syringe lot # T013204 with an expiration date on 03-DEC-2021, 0.5 milliliter once, for prophylaxis. No additional adverse events or product quality complaints were reported.
Shoulder pain; This is a spontaneous report from a contactable physician (patient). A 73-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 01Feb2021 (Batch/Lot Number: EL9265) (at the age of 73 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient didn't have much of local discomfort with the first vaccine injection and only reported to experience shoulder pain on an unspecified date in Feb2021. The patient underwent lab tests and procedures on an unspecified date, which included multiphasic blood chemistry, brain natriuretic peptide (BNP), full blood count (CBC), and pulmonary function test: All with an unknown results. The outcome of event shoulder pain was unknown.
Caller stated that she received her vaccine on 01/21/2021 and started having a weird (metallic)senation to her tongue and is not getting better. Member advised follow up with her PCP and is scheduled to see an allergist in 2 weeks.
Pt developed increased work of breathing about 10 min after injection. Used albuterol 8 times with little improvement. HR remained 74-88, BP122/73, 118/56. RR 40-50 O2 sat 99-100. Pt did not want EPI.  Was given 50 mg of Benadryl without improvement.  Pt denied CP, throat symptoms, nausea/vomiting, headache or dizziness. Monitored for 30 min in vaccine clinic without progression of symptoms. Pt declined emergency transport, so was taken via wheelchair to ER for further monitoring.
I got sick on Thursday morning on 10/06/2022. I took a COVID-19 test which was very positive. I called my doctor and went to urgent care to get examined and I did test positive again. They gave me some cough medicine and gave me some antiviral medicine and I ended up calling my doctor to make sure he agreed. I am still got a little head congestion with some drainage but may be coincidental with my allergies and still am not as energetic as before that I got sick.
Vaginal Bleeding for 2 -3 days.  Had stopped my Monday. Pain in Left arm that continues to present
Minutes after shot: felt slightly faint, tingling in feet and fingers, nauseous, sense of taste was off. Nausea and altered taste lasted about 3 hours. Insomnia beginning 10 hours after shot. 14 hours after shot: headache, fever 101, pain on left side of chest/spleen area, severe left arm pain, pain in left shoulder and forearm, fatigue, loss of appetite.
45 minutes after shot intense headache started at back of head then entire face and left arm went painfully numb.  Numbness down left arm has subsided but sometimes is painful in upper left arm and face still has some numbness but is much less intense.
14x14 cm cellulitis around injection site. Treated with antibiotics, BENADRYL and oral steroids.
Brain fog, confusion, mixing the order of words, dizziness in addition to other more normal vaccine reactions including low grade fever and pain at injection site. I could not drive. The brain fog and fever lasted for five days. I still have harder time concentrating and occasional brain fog and mixing words nearly three weeks post-booster. Minor: I also still have pain at the injection site, which is near a titanium pin in my arm.  I have had a concussion before (but ten years before!). I seemed to have fully recovered long before the booster. The booster effects were similar to the concussion.  I had no adverse reaction to either of the two prior COVID vaccine shots.
arm pain (unspecified) following the injection; shoulder and neck stiffness; Pain was bilateral shoulders earlier; Neck is till sore, midline to posterior; This is a spontaneous report from a non-contactable nurse (patient herself that works at the surgical center of the hospital). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EX9231, expiry date: Apr2021), via an unspecified route of administration on 03Jan2021 at a single dose as Covid-19 vaccine. The patient's medical history and concomitant medications were not reported. Patient received flu vaccine on 29Oct2020. On 03Jan2021, the nurse reported some arm pain (unspecified) following the injection and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day. On 03Jan2021, pain was bilateral shoulders earlier, now subsiding. Neck was till sore, midline to posterior. The event arm pain (unspecified) following the injection was recovered on 04Jan2021. The patient was recovering from shoulder and neck stiffness and "pain was bilateral shoulders earlier". The outcome of the event neck was till sore, midline to posterior was not recovered.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse, who reported that an unspecified pharmacist told her that on an unspecified date the pharmacist's child (age and gender not reported) received a dose of VARIVAX (Merck) (lot  # not reported) (dose and route not reported). Concomitant medications were not reported. On an unknown date, the patient developed shingles on his or her hand after receiving VARIVAX (Merck). At the time of the report the patient's outcome was unknown. This case is related with MARRS 1307USA010279 and 1307USA012821. Additional information has been requested.
nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EL9265, Expiration date: unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing blood pressure and acid reflux. Concomitant medication(s) included vitamin c, VITAMIN D3, calcium, zinc, blood pressure medication and acid reflux medication. The patient did not want to take the vaccine but her son insisted she took it so she went with him. The patient reported that she got the first dose of the vaccine and she did not think she paid much attention that day. The first day the patient threw up at breakfast and felt real nauseated then continued to have nausea with an upset stomach all day long and she did not know if that was making her headache or what, but she was nauseated all day long. The second day, she had a stomach upset. She went out that day and came home. She could not remember if she ate anything or not but then the next day she got nauseated with an upsets stomach. One night, she had itching all over her body then she feels like just blah. She took a Benadryl toward the morning because she could not stand the itching and thought if it was some type of allergy or something, maybe it could cut it down and she finally got to sleep. She wanted to know about the second dose because she heard a lot of people were super sick with the next vaccine and if she was having problems right now, whether she should take the another one. She saw the date range 17Feb2021-24Feb2021 and COVID 19 vaccine. She regularly took a blood pressure medication and an acid reflux. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
The patient  came by yesterday and showed the rashes at the torso part of body. He said, he was taking hydroxyzine as his med, so didn't feel itchy.  He  just noticed it the next day after the vaccination, in the afternoon. The rashes were fading now. Advised pt to see doctor to diagnosed if there is any cause.
malaise, h/a began first day;third day devel indurated, erythematous area measuring 8-10cm @ site of inj;resolved by 19JUN98;