chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; headache; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were unknown.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Age group was captured as adult as per product indication. The patient received 2nd shot Monday and had a terrible reaction Fever chills headache.
Patient suddenly became tired and lethargic and refused to eat then she began vomiting over and over again. She dehydrated very quickly. Ran only a low grade fever. Complained constantly that her hands were tingly and her fingers were completely numb. She also got a bad UTI, however I dont know if that is related to the vaccine or not. She Required IV fluids. She has not been around anyone that was ill so I looked online and found that TONS of people have become ill from these vaccines, especially the live vaccine given in the nose which is what was given to patient. People are complaining of the exact same symptoms anywhere from one day to a month after receiving the H1N1 vaccine.
Since receiving the vaccine, she has been having body twitches; worse than shaking; loss of motor function at time; there's times she cannot talk. She can make noises and not words; Her body felt like it's trying to curl up into a ball; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 (Lot number: PAA165969) at the age of 41 years as dose 2, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Relevant medical history included: "eosinophilic esophagitis" (unspecified if ongoing); "cliff diving accident shattered pelvis" (unspecified if ongoing); "neck herniations" (unspecified if ongoing); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known Allergies: shellfish, cholostyramine, entasa, regalin" (unspecified if ongoing). Patient had no covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication(s) included: GABAPENTIN; LORATADINE; ARMOUR THYROID. Past drug history included: Cholestyramine, reaction(s): "Allergies"; Pentasa, reaction(s): "Allergies". Vaccination history included: Bnt162b2 (Dose 1, lot number unknown, Unable to locate or read the details), for COVID-19 immunization. The following information was reported: MUSCLE TWITCHING (disability) with onset 15May2021, outcome "not recovered", described as "Since receiving the vaccine, she has been having body twitches"; TREMOR (disability) with onset 15May2021, outcome "not recovered", described as "worse than shaking"; MOTOR DYSFUNCTION (disability) with onset 15May2021, outcome "not recovered", described as "loss of motor function at time"; SPEECH DISORDER (disability) with onset 15May2021, outcome "not recovered", described as "there's times she cannot talk. She can make noises and not words"; MALAISE (disability) with onset 15May2021, outcome "not recovered", described as "Her body felt like it's trying to curl up into a ball". The events "since receiving the vaccine, she has been having body twitches", "worse than shaking", "loss of motor function at time", "there's times she cannot talk. she can make noises and not words" and "her body felt like it's trying to curl up into a ball" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Sep2021) negative. It was unknown if therapeutic measures were taken as a result of muscle twitching, tremor, motor dysfunction, speech disorder, malaise.
Pt. came to hospital with scatter bruising to legs noticed after COVID vaccine on Saturday. Nose bleeds since COVID vaccine. Had one in the hospital, but no more were reported.
Pt recvd vax on 22JUN92 w/in 15 mins of vax pt exp heart palpitations w/heart rate of 120 beats/min, chest pain, dyspnea, flu-like sx, paresthesia, feeling of impending doom; dx hypothyroidism;
Approximately 1 hr following immunizations-patient reported to medical with raised hive like rash on (R) upper arm-large bumps about 6-7 in number with c/o itching-(L) arm 2 raised hive like bumps with itching-slight wheeze LLL-no facial edema-no SOB-Epi 0.3mg administered via EPIPEN.
VISIBLE WELT/KNOT AT SITE OF INJECTION, STILL SORE/ACHY, 1 WEEK LATER AND ITCHY.  BEEN GETTING WORSE OVER TIME RATHER THAN BETTER.  FORM FILLED OUT ON 12/30/20
FLUBLOK was given to a 12 years old patient/ No AE; Initial information received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old male patient who received 0.5 ml dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2041, expiry date: 30-Jun-2021) via intramuscular route in left arm on 01-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  No  concomitant therapy given to the patient.  It was an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Severe headache and jaw and joint pain. Nausea and rapid heart rate for 6-7 hours. Fever 99.9 and chills, dizziness, debilitating weakness and fatigue lasting 24 hours. Continuing moderate fatigue.
Numbness and tingling down to fingers; Tingling down to fingers; Severe dizziness; Nausia; Bedridden; This case was reported by a consumer and described the occurrence of numbness in fingers in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced numbness in fingers, tingling of extremity, dizziness, nausea and bedridden. On an unknown date, the outcome of the numbness in fingers, tingling of extremity, dizziness, nausea and bedridden were recovered/resolved.   It was unknown if the reporter considered the numbness in fingers, tingling of extremity, dizziness, nausea and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and awoke to numbness and tingling down to fingers in left arm and severe dizziness leading to nausea.  The symptoms lasted 1.5 days rendering the patient bedridden.
he started feeling weak and chills; he started feeling weak and chills; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiration date unknown) via an unspecified route of administration on 30Jan2021 at a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband got his first COVID-19 vaccine yesterday and now, 31Jan2021, he started feeling weak and chills. Outcome of the events was unknown.    Information on the Lot/batch number has been requested.
patient called pharmacy on 09/4 experiencing swelling, redness and pain in whole left arm closer to pneumonia site injection, patient got both pneumovax and flu shot in left arm and twinrix in right arm (no issues in right arm) patient also stated pain in armpit of left arm. Upon follow up with patient on 09/6 patient stated swelling and pain had decreased substantially and is treating with arnica pain gel
GARDASIL 9 was administered to a 75 year old patient due to recurrent abnormal pap smears; GARDASIL 9 was administered to a 75 year old patient due to recurrent abnormal pap smears; This spontaneous report was received from an office manager referring to a 75 years old female patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.  On an unknown date, the patient was administered HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) due to recurrent abnormal pap smears (Product use in unapproved indication, Inappropriate age at vaccine administration).   The reporter could not confirm if the product was not administered and did not have any patient information. The reporter did not have any further information at this time.
Red below site of injection, 3 days after vaccine. Discoloured and bruising above inject. site after 3 days.
I received the Vaccine right about 7 :35.  I went straight home and to bed.  I woke up at 11:00 so hot I felt like my skin was burning..  I walked around a bit to cool off and started feeling itchy.  So I took one of my Pills for Itching the Hydroxyzone at 25 mg.  after a while the itching lessoned.   I did wake up with a fever but did not realize it because I take the Celebrex on a regular schedule for pain in my spine.  I only realized I had a fever When the cold feeling started to subside after taking my morning dose of the Celebrex.
PATIENT STARTED HAVING SNEEZING, COUGHING AND THEN SWELLING OF BOTH EYE LIDS.  PATIENT WAS ADMINISTERED BENADRYL 7ML  X1 AND EPINEPHRINE 1:1000 INJECTION.  PARAMEDICS CALLED AND TRANSPORTED TO THE HOSPITAL.
I had the same symptoms that lead to my March 19, 2020 (13 months ago) ER admission to hospital, where I presented with left flank pain, diarrhea, cold sweat, nausea, dizziness, very high blood pressure, and feeling of malaise.  Symptoms started within 7 days after the 2nd injection.  Went to doctor on Apr. 16, 2021 with the same symptoms described above, except cold sweat.  Had left flank pain that made walking difficult, diarrhea, nausea, dizziness, and BP 189/88.  Normal BP is 140/88.  Urinalysis showed blood in urine.  Other results of blood test were not provided as of this date.
No Adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     It was not given if the patient was allergic to medications, food, and other products. It was unknown if the patient ever been diagnosed with or tested positive for covid-19. It was unknown if patient has illnesses at the time of vaccination and up to one month before. It was unknown if patient has chronic or long-standing health conditions. It was unknown if the patient was taken over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant product use was not provided by the reporter. Patient received 2nd and 1st booster dose.  Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow up has significant information which included reporter detail, patient note, vaccine Information (suspect product route of administration, dose) and i-narrative supplement were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
1300 hives around eyes, flushed skin, crying. 1304 2.5 BENADRYL - vomited. 1308 .1ml EPI. 1313 2.5ml BENADRYL.
LOCALIZED REDNESS AT INJECTION SITE LENGTH 2MM AND WIDTH 3MM. PATIENT ALSO C/O ITCHINESS AT INJECTION SITE
CONFIRMED COVID19 INFECTION; DEATH; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 76 year old male. 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: 206A21A, expiry: unknown) dose was not reported, 1 total was administered to right arm on 09-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. About the first week of OCT-2021, the patient felt ill and went to an urgent care, performed rapid test result came negative, two days later he went to the ears, nose, throat (ENT) with worsening symptoms, and had another rapid test still negative. On 15-OCT-2021, the patient went to the hospital and was feeling severely ill, he was critical in the hospital and did polymerase chain reaction (PCR) test and tested positive (confirmed clinical vaccination failure, confirmed covid19 infection (acute hypoxia)), by then he was advanced and had significant lung damage. The number of hospitalized day was unspecified. On 03-NOV-2021, the patient died from unknown cause of death. An autopsy was not performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was fatal and outcome of confirmed clinical vaccination failure and confirmed covid19 infection was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20211152663. This report was associated with product quality complaint.; Sender's Comments: V0: 20211151782-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS   20211151782-Covid-19 vaccine ad26.cov2.s-Death, Confirmed covid19 infection . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Extreme pain in arm and shoulder.  Pain worsened as evening and night progressed.  Pain woke me during the night.
Patient described and provided pictures of a red, swollen, hot, lump with tiny blisters around the injection site accompanied by a fever and headache. Patient took Aleve and applied an ice pack. Patient reported on 8/2/19 that her headache and fever had resolved.
Information has been received from a medical assistant cornering a 15 month old female who on 16-OCT-2009 was vaccinated with a dose of MMR II. Concomitant therapy included "ENDOCIL", PREVNAR and "Flu vaccine". On 26-OCT-2009 the patient experienced a rash on her head and chest. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Follow up information was received from the physician who indicated that the child was vaccinated with the first SQ dose of MMR II (lot No. 663929/0511Y) in her right arm. Concomitant vaccination included PENTACEL. On 25-OCT-2009 the child developed rash on her face and chest; no fever or other symptoms were noted. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Large red circle rash (4 inches in diameter) appearing at site of injection. Appeared 6 days after shot
Collapsed lung; A spontaneous report was received from a consumer concerning herself, a 79 year old patient who received Moderna's COVID-19 vaccine and experienced collapsed lung.  The patient's medical history included COPD.   On 8 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number:025L20A) and on 5 Feb 2021, the second dose of mRNA-1273 (Batch number:032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The event collapsed lung was experienced in Feb 2021 that lead to hospitalization for about 3 days. The patient reported that she has performed a biopsy on Feb 2021. Treatment for the event included IV steroids and oral prednisone.  The reporter has also mentioned that the event, collapsed lung is not related to the vaccine.  Action taken with mRNA-1273 in response to the event(s) was unknown.   The outcome of the event collapsed lung was not recovered/resolved.; Reporter's Comments: Based on the current available information, which includes a pre-existing history of COPD and the time to event onset from vaccine administration, a causal relationship between the event and product use is assessed as unlikely.
MAY HAVE BEEN ADMINISTERED WITH WRONG DILUENT.  WILL NEED TO BE RE-DOSED
After receiving immunizations syncopal episode occurred. She stood up, eyes rolled to the back off her head and fainted.  She fell backwards hitting right arm and possibly her head. Laid on floor.  Pillow under head, juice given, ice applied to right arm.  20 minutes observed.  Waited 10 more minutes in waiting room.
Chills for about 1 hour. Fever, body aches,  and sweating  about 8 hrs.  Headache and fatigue for about 2 days.
pt recv vax & devel facial swelling & in inj site rxn, characterized by redness & swelling
Patient received first dose of J+J on 8/2/2021 Lot # 043A21A. Then returned with a different ID stating - same DOB but different address on 8/15/2021 to our  location and received dose #2 of J+J to right arm again that Lot # is- 042A21A.
pt had tachycardia @ 148, this decreased to 95 within 15 minutes then increased to 124. symptoms resolved within 25 minutes and patient left symptom free, advised to speak to obgyn for additional question
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo since 2018 and Blood pressure high (under control with medications Benazepril 20mg, Amlodipine 5Mg. Spironolactone 25mg). Concomitant products included BENAZEPRIL, AMLODIPINE and SPIRONOLACTONE for Blood pressure high.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). On 11-Apr-2021, VACCINATION SITE PAIN (Sore left arm) had resolved.            No treatment medication was provided.   This case was linked to MOD-2022-480662, MOD-2022-480677 (Patient Link).
10/14/09 Report from pt via phone call. On 10/2, awakened feeling okay - went to bathroom. While on toilet had sudden onset of numbness in upper back and across "shoulder blades". Walked to bed - laid down - rapid progression to "sweating", "panic" feeling and sensation of "blacking out". 911 called. Rapid progression of tingling - eventual numbness to legs. Admitted to ER - and hospitalization. Pt continues to recover. At this writing is able to walk with assistance.   11/2/09 ICD-Codes received: 356.9 Idio Peripheral Neurpthy NOS, 341.20 Acute (Transverse) Myelitis NOS, 054.9 Herpes Simplex NOS, 427.89 Cardiac Dysrhythmias NEC, 458.0 Orthostatic Hypotension.   11/5/2009 Discharge summary and lab results received for DOS 10/02/09-10/04/09. Final DX: Transverse myelitis with residual bilateral upper extremity weakness. Improving. Orthostatic hypotension.  Patient woke up with tightness in upper back. Weakness in L arm. Weakness, numbness. Progressed to lower extremities. Felt faint and cold sweats. Tingling.  Strength decreased UE (1-2/5). Could not lift arms off bed.  LE sensation diminished.  Decreased sensation across chest wall. DTR decreased all four extrem. Neg Babinski bil.  Extensive herpes simplex cold sores. Bradycardia and postural hypotension autonomic dysfunction s/t CNS problem. EKG WNL.  MRI abnormal. Steroid therapy. Improved. Transfer to rehab facility.
red raised rash all over body on 26APR98;started behind ear-restless during noc-mom denied fever;inc itching-rash quickly spread all over body;MD eval 27APR98 dx w/hives poss r/t immunization;
fever of 100.8 Deg. F; chills; hurt all over; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 100.8 Deg. F), CHILLS (chills) and PAIN (hurt all over) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PYREXIA (fever of 100.8 Deg. F), CHILLS (chills) and PAIN (hurt all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 100.8 Deg. F), CHILLS (chills) and PAIN (hurt all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.