chrisvoncsefalvay/vaers-outcomes huggingface dataset:
trying to get the third dose now off schedule; This spontaneous report was received from a pharmacist referring to a current 25 years old patient of unknown gander. The patient got the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) in September 2019 and the second dose in December 2019 for prophylaxis. The patient was trying to get the third dose now off schedule (inappropriate schedule of vaccine administered).
feels sick as a dog; face is swollen; eyes are puffy; looks terrible; nightmare; vomiting; fever; burning; arm was on fire; her arm got paralyzed and she couldn't move it; couldn't move arm or fingers; hard; swelled up; shooting pains all the way down arm and up to neck; could not hold cellphone or steering wheel; heart was racing for at least ten minutes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burning), BURNING SENSATION (arm was on fire), MOBILITY DECREASED (her arm got paralyzed and she couldn't move it), LIMB DISCOMFORT (couldn't move arm or fingers) and INDURATION (hard) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX COSMETIC) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SKIN BURNING SENSATION (burning), BURNING SENSATION (arm was on fire), MOBILITY DECREASED (her arm got paralyzed and she couldn't move it), LIMB DISCOMFORT (couldn't move arm or fingers), INDURATION (hard), SWELLING (swelled up), PAIN (shooting pains all the way down arm and up to neck), FEELING ABNORMAL (could not hold cellphone or steering wheel) and HEART RATE INCREASED (heart was racing for at least ten minutes). On an unknown date, the patient experienced MALAISE (feels sick as a dog), SWELLING FACE (face is swollen), PERIORBITAL SWELLING (eyes are puffy), FEELING ABNORMAL (looks terrible), NIGHTMARE (nightmare), VOMITING (vomiting) and PYREXIA (fever). At the time of the report, SKIN BURNING SENSATION (burning), BURNING SENSATION (arm was on fire), MOBILITY DECREASED (her arm got paralyzed and she couldn't move it), LIMB DISCOMFORT (couldn't move arm or fingers), INDURATION (hard), SWELLING (swelled up), PAIN (shooting pains all the way down arm and up to neck), FEELING ABNORMAL (could not hold cellphone or steering wheel), HEART RATE INCREASED (heart was racing for at least ten minutes), MALAISE (feels sick as a dog), SWELLING FACE (face is swollen), PERIORBITAL SWELLING (eyes are puffy), FEELING ABNORMAL (looks terrible) and NIGHTMARE (nightmare) outcome was unknown and VOMITING (vomiting) and PYREXIA (fever) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment product information was provided.
12/7/20  Left arm extreme pain, could not bend elbow or lift arm. Took  2 ibuprofen  (200mg each) at 1:45; 1 at  2:35; 1 at 3:50, 1 at 9:10, 2 at 11:00pm 12/8/20  Shoulder pain. By afternoon, could bend elbow to 90*; Took 2 ibuprofen at 10:15am; 1 at 2:30pm; 2 at 11:30pm. 12/9/20  9:00am could touch shoulder with fingertips & lift arm 45* front & back; lift 35* to side.  Shoulder pain. Took 2 ibuprofen 10:15am 12/10/20  Shoulder still sore & stiff; took 2 ibuprofen at 10:00am.  Can lift arm to 90* front & side; can touch shoulder from the side. 12/11/20  Can lift arm 180* front &  135* side. Front of shoulder still feels stiff. 12/12/20  Some pain & stiffness  in front of upper arm & shoulder. 12/13/20  Arm  about  2 inches  short of full rotation. 12/14 - 12-17, 2020  Full movement, no pain.
Pt recv vax on 10/27/98; on 10/28/98 pt exp fever (100-102.6), nausea, chills, trembling, unable to talk & stand, aches, dry heaves, weak, muscle pain at vax site; tx=Tylenol
Weakness, dizziness, nausea, vomiting, rash on (L) arm
after receiving the his Shingrix vaccine with us, within 7 days he had the Shingles virus / experienced the Shingles virus; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and within 7 days had the Shingles. The doctor recommended to report it and to find out if the patient allowed to get a second dose of vaccine, as the patient would be coming up due in just a couple months.  The reporter stated that he/she was calling about the same  The patient was treated for the Shingles.  The reporter consented to follow up.
fever of 103, headache,, chills, body aches, nausea, swollen lymph node , lasted 40 hours. lymph node is still swollen 6 days later
Began in March 2021 with reflux.  April 2021 progressed to right eye drooping.  June 2021 dizziness, slurred speech, difficulty in chewing and swallowing, right arm weakness, fatigue, difficulty in hold head up when standing.  July symptoms progressed and was diagnosed with Myasthenia Gravis.  August went into Myasthenia Gravis Crisis and was admitted and intubated.  Given immunoglobulin and started in Prednisone and Mestinon.  Symptoms now well controlled with medication.
Received shot 9/30/14. Next day achy/fever -> flu like symptoms. Daily progressively worse breathing harder, fever, and still achy. Pt declined visiting MD. Wanted reported to see if other people sick after quadrivalent shot.
Feverish, non-stop screaming for hrs. Seen by MD. No family hx of allergies or rxns to vaccine. 1st injection
administered doses of the affected lot after the Sept. 30 expiration date but on or before Oct. 19.  manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required. Any dose administered on or after Oct. 1 must be reported in database and VAERS.
12 hours after vaccination developed debilitating inability to think clearly, brain fog, shortness of breath, activity intolerance, heat intolerance , headaches, fatigue  that have not subsided since.
pt recv vax;on 29apr96 devel a varicella rash described as clear, fluid filled blisters  with erythematous roses on chest, back and face;  pt's brother was vaccinated w/ varivax at the  same time, devel chicken pox on 15may96;
Fever (102.0 F).  Chills.  Headache.  Body aches.  Skin sensitivity to touch.  Rash.  Painful large hive-like welts.    Fever, chills, body aches lasted about 12 hours.  Rash/hives still present after 1 week.
shivering/ chills; headache; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2019, the patient received Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced shivering, headache and upset stomach. On an unknown date, the outcome of the shivering, headache and upset stomach were recovering/resolving.   It was unknown if the reporter considered the shivering, headache and upset stomach to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's brother. The reporter stated that the patient experienced Shivering, chills, headache and upset stomach. The reporter did not consent to follow up.
Sssssss sound in ears. Especially noticeable in afternoon or early morning (when fairly quiet)
Headache, Arthralgia, Fever, Chills, Fatigue Narrative:
patient is only 17 years old; Arm soreness for 1 day; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 17 years old) and PAIN IN EXTREMITY (Arm soreness for 1 day) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Crabs, shrimp).   On 06-May-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 17 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness for 1 day). On 06-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 17 years old) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness for 1 day) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added other relevant history. Added new event-pain in extremity. Added second dose details of a patient. Updated reporter information and patient details. Updated the time of first dose. Updated action taken in products tab and product-event details.
Not shaking preparation; Not shaking preparation; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAR-2023 Reporter's Comments: The registered nurse reported not shaking syringes in preparation for administration, as the package insert stated. PQC Unrelated. PQC and adverse event share same case number. The reporter did not consent to follow-up. Additional Supportive Information:  The syringe of Pediarix vaccine were not shaken in preparation for administration, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Cellulitis: below left elbow; Soft tissue swelling; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient (62 years old at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscular in left upper arm on 21Dec2020 13:00 at a single dose for COVID-19 immunization administered in the hospital. Medical history included ongoing hypertension and cervical cancer from 2015 and ongoing. The patient has been taking unspecified concomitant medication/s. The patient previously took amoxicillin and had allergies and nausea. On 24Dec2020 16:00, patient had cellulitis below left elbow and soft tissue swelling. On 25Dec2020, patient went to ER and X-ray was taken and patient was prescribed Keflex 500mg 3x day. Prior to vaccination, the patient was not diagnosed with COVID-19: Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient states all doses have been bad; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Patient states all doses have been bad) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 037B21A and 004C21A) for COVID-19 prophylaxis.     The patient had no Allergies (medications, food and other products).  The patient never had COVID test or diagnosis previously.  Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ROSUVASTATIN for Blood cholesterol abnormal, AMLODIPINE and METOPROLOL for Blood pressure abnormal.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient states all doses have been bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (Patient states all doses have been bad) was resolving.            No medical history information reported.   This case was linked to MOD-2022-591722 (Patient Link).
Swollen glands in the upper part of the left armpit moving into the arm. Painful to touch.
Received a pneumonia vaccine on 3-20-07. Developed a swelling and redness at injection site. Within 2 days had confusion and change in mental status. Was seen in ER and admitted to hospital. Treated for encephalopathy, transferred to different hospital by ambulance and air. Was in semi conscience state for 1 month. 7/10/07-records received for DOS 3/23-4/02/07-DC Summary: slight confusion progressively more confused to point where he is aphasic for last 2 days, bradykinesia, tremors and completely unresponsive. Etiology unclear.  Transferred to another facility.  7/19/07-seen on 3/20/07- C/O fatigue, cough sore throat, ear pain, headache, stuffy nose, occasional nausea nd diarrhea. Impression Upper respiratory infection.  7/25/07-records received from facility for DOS 4/3-4/17/07 DC DX: Encephalopathy. Wernicke's encephalopathy. Alcohol dependence. Malnutrition. Urinary retention. Hyperglycemia secondary to steroids. C/O Mental changes and confusion. Seen by psychiatry for Dementia. On 3/23/07-Initially admitted for progressive confusion, aphasia, brandykinesia, tremors and unresponsiveness etiology unknown.
Sneezing and stuffy, runny nose beginning 2-3 days after receiving FluMist.
High fever - severe chills (shaking) body aches, headache. Called pharmacy - 10-06 - said normal, visit doctor 10-11 - immune system low - upper respiratory infection - ZITHROMAX 250 - better, but still have no energy. Dr wanted shots 1 at a time - pharmacy assured/insisted all together would be fine.
This was the Pfizer booster shot---For 26 hours, fever >100, body aches, chills, and headache
Pfizer-BioNTech COVID-19 Vaccine EUA. Itchy left palm, slight swelling in left palm, finger joint pain in left palm. Symptoms last about an hour after presentation.
by 5:00PM Thursday stools were loose and contained mucous; by 5:00AM Friday stools were loose and contained mucous and streaks of blood and hacking cough was developing; by 5:00PM Friday stools were loose and contained mucous with light tinting of blood and low grade temperature had developed that was treated with a normal dose of Ibuprofen and hacking cough was becoming more pronounced, breathing was becoming more difficult (called Ask A Nurse at Clinic for direction; by 5:00AM Saturday intermittent nausea was occurring, the low grade temperature was persisting and continued normal dosing with Ibuprofen was required; 5:00PM all symptoms were getting worse so finished a job I was on and headed over to Hospital Emergency Room at about 8:00PM; was in the Emergency room from 8:00PM to 12:00 midnight, chest ex-rays, IV liquids, two intravenous antibiotics, catheter urine sample taken, blood drawn, rectal exam,
Swelling, pain, locking of joints throughout left arm, linger to this day though diminished. had same symptoms linger after covid infection
Left thigh where shot was given developed a large red, warm area with central induration. No limp, steadiness. Thought to be either a large, localized reaction vs. cellulitis. Patient treated with Keflex.
I have seen 2 patients with symptoms partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination; This is a spontaneous report from a contactable physician. This Physician reported similar events for 2 patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter had seen 2 patients with symptoms partially resembling systemic capillary leak syndrome after Pfizer Covid vaccination on an unspecified date with outcome of unknown.  The most recent, reporter was considering trying to get IVIG treatment. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between the event capillary leak syndrome and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101324931 same product, reporter and event, different patients.
Patient received 2nd COVID (Pfizer) vaccine on 5/21/21, with sweats and chills but otherwise no other issues.  On 5/26/21, he note left lower extremity edema.  This did not resolve with compression hose and went to hospital for a venous doppler revealing a nonocclusive DVT in the left lower extremity politeal and calf veins.  He does not smoke, no change in activity, no recent travel by car or air.  He is on lenalidomide and takes aspirin 81mg PO QD.
Woke up with non-itchy rash. Temp of 103 the previous day.
IN BED ALL WEEK; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced in bed all week. The action taken with covid-19 vaccine was not applicable. The patient recovered from in bed all week. This report was non-serious.
Vaccine vial store for longer than recommended post puncture of vial (potentially up to 28 days) no adverse reaction
I had a horrible migraine which started a few hours after I got the shot for four days. I went Ito the Chiropractor and I got some relief after my visit. II still had the migraine for another day after that. It seemed the same as my normal migraines but lasted longer. I was very sleepy for a week after the shot. I have not had any more since the first week after the shot.
fever 104 @ home & exp sz x 2 @ home;as reported by mom;pt seen by ER MD-placed on motrin & sent home;mom saw MD 26JUN96 reported being unhappy w/ER MD assessment;MD sx OM & place pt on med;MD does not feel this is r/t vax
about 4 hours after getting the flu shot, noticed pain to deltoid area that has progressed over the last 3.5 wks with increased pain, feeling numbness to the forearm and ulnar side of the hand, with tingling to proximal L forearm and overall decreased ROM to the L shoulder; some weakness to LUE
Patient seen 9/6/06 for administration of DTap #5, IPV #4, and MMR #2.  Both DTap abd MMR administered in R anterior thigh.  Patient returned 9/8/08 due to siginificant swelling of R thigh.  Swelling extended from hip to knee.  Area was also red and warm to touch.
This spontaneous report as received from a 70 year old female patient regarding herself who had no drug reactions or allergies. Pertinent medical history was none. On 03-OCT-2007, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported) in the left arm. Concomitant medication was none. On 15-MAR-2013, the patient developed a painful blotchy rash behind her left ear and hairline. The patient sought medical attention for the same and visited the physician's office on 18-MAR-2013 and was diagnosed with shingles. Laboratory test was not performed. The physician had prescribed valacyclovir, 1 pill for 10 day. The pain had subsided within 3 days and the rash was slowly disappearing. Approximately on 17-MAR-2013 (reported as within 3 days), the event pain was recovered. The outcome of shingles and blotchy rash behind her left ear and hairline was reported as recovering/resolving. Additional information has been requested.
Right deltoid area had red, puffy reaction 8.5 x 5 cm red patch.
Works at grain elevator across from Health Dept. Employer noticed that he was confused and called his wife who works at the Health Dept, to come get him. She brought him in to have BP checked. His color was slightly flushed. BP was 100/?, then became very pale "diaphoretic" with no complaints of pain. Lowered to the floor, feet elevated on scene. O2 administered per nurse. Pt's main complaint is that he can't remember anything. Was admitted to hospital on the eve of 11/6/00 and discharged on 11/7/00.
Tingly lips and face for several hours Dizziness for several hours Sore arm continuing Felt faint for several hours
Patient reported difficulty breathing, feeling warm, hands sweaty approximately 15 minutes after receiving second COVID-19 vaccine (Moderna) dose. VS stable BP 127/74, HR 86, O2 sats 100%, RR 14. Referred to ED staff/provider (physically located in same building) for further evaluation and management due to patient report of difficulty breathing. Patient walked over to ED location and ED nurse assumed care for patient.
Mother called in AM to report patient had vomited 5x. No fever, no discomfort just headache called back in the PM to learn patient was better and brother had headaches the previous week.
Pt got shot around shoulder bone and she started experiencing shoulder pain, then spreading to arm and wrist.