chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Headache; Fever of 100.2; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 10Apr2021 at 16:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and breast cancer. The patient received unspecified medication within two weeks of vaccination. The patient previously took amoxycillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 12:00, the patient experienced fatigue, headache and fever of 100.2. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of fatigue, headache and fever of 100.2 were recovered on an unknown date Apr2021.   No follow-up attempts are needed. No further information is expected.
arm was sore; temperature of 99.6F/temperature was 101.5F/temperature was 100.6F; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), PYREXIA (temperature of 99.6F/temperature was 101.5F/temperature was 100.6F) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A12A and 012M20A) for COVID-19 vaccination.     No medical history was reported by the reported.  Concomitant products included LEVOTHYROXINE, LOSARTAN, GEMFIBROZIL, ESTROGENS CONJUGATED (PREMARIN), FLECAINIDE, DILTIAZEM, ZOLPIDEM, CYCLOBENZAPRINE and LUBIPROSTONE (AMITIZA) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), PYREXIA (temperature of 99.6F/temperature was 101.5F/temperature was 100.6F) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), PYREXIA (temperature of 99.6F/temperature was 101.5F/temperature was 100.6F) and FATIGUE (tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (Inconclusive) woke up with temperature of 99.6F, 101.5 (Inconclusive) during day she states that her temperature was 101.5F and 100.6 (Inconclusive) during night her temperature was 100.6F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.
This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 62, via an unspecified route of administration, in the left arm, on Mar 28, 2021, at 11:00, single dose, for COVID-19 immunisation. Medical history included vertigo. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient has no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 62, via an unspecified route of administration, in the left arm, on Feb 7, 2021, at 00:00, single dose, for COVID-19 immunisation. On Apr 14, 2021 at 02:00, patient was extremely dizzy for 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of extremely dizzy for 2 weeks: not recovered (at the time of this report). No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Fever in the pm:  101.1 degrees 12 hrs after receiving shot (3/27/21) 99. 7 degree starting at 5:00pm the following day (3/28/21) 99.1 degrees starting at 4:30pm (3/29/21) Temperature retuned to normal after taking Tylenol
No adverse event noted. A fourth dose of PENTACEL was given when it was not due.
Pt recvd 3 doses of Engerix-B 19OCT90; 4DEC90 & 3MAY91; 28JUN91 tested for Anti-HBS & found to be non-reactive; 18JUL91 recvd 4th Engerix-B dose;
Rash/red raised bumps starting on inside forearm, moved to upper arm, legs, thighs, feet, hands, breast - itchy but mostly at nighttime
muscle pain in upper part of right arm (same arm as injection) pain is decreasing over time but not gone
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical histories, drug reactions or allergies provided. On an unknown dates, 7 improperly stored doses of (Oka/Merck) VARIVAX (lot# K026386, expiration date 15-DEC-2015, dose, frequency, site and route of administration were not reported) were administered to unspecified number of patients. No adverse events were reported. No product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
high fever up to 103 1 day p/vax; gen maculopapular rash from face down to extremities;-2 days p/cervical lymphoidenivitis-change day p/high WBC count 32,900;
fever & rash beginning 9 days p/MMR; as of 18SEP92 rash has become typical of JRA, ESR-90, fevers persist, on Ibuprofen;
Syncope upon standing repeatedly starting when waking in morning. Nausea, hypotension per home test and per ER. Dehydration and tachycardia also confirmed per the ER. Syncope resulted in face lacerations and contusions at 6:25 am, followed with urgent diarrhea. Went back to bed and fainted 3 more times just trying to get back out of bed later. Hydrated with Pedialyte enough to visit  ER from 1 pm-2pm. Labs taken (unsure of what) and EKG was normal. Remained tachycardic upon discharge struggling to maintain BP through the evening- fever of 102 and with bad whole body pain and nausea. Horrible experience. Large bill expected, eye is disfigured, emotional trauma, missed a day of work at my medical facility where we are short staffed anyway.
This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 69-year-old female patient who received TWINRIX adult. Co-suspect products included TWINRIX adult and TWINRIX adult. Concomitant products included prednisone and Cholesterol Medication (NOS). In July 2017, the patient received the 1st dose of TWINRIX adult 1 ml. On an unknown date, the patient received the 2nd dose of TWINRIX adult 1 ml and the 3rd dose of TWINRIX adult 1 ml. On an unknown date, less than a year after receiving TWINRIX adult, TWINRIX adult and TWINRIX adult, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknwon. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additiononal information was reported as follows: The patient received Reflux medication concomitantly. The age at vaccination was not reported. The caller center representative reported that the patient completed his 3 series vaccine schedule of TWINRIX adult. The patient's last blood work was done in February 2018 and result showed that the vaccine increased anti-bodies for HAV and HBV. Lack of drug against vaccine was reported. The reporter stated patient's health care professional might had to take the series again (potential off label). The patient received first dose of the vaccine in July 2017 and it was administered in pharmacy. The patient's HCP was ware of the blood test.
Within 2 hours of injection patient experienced fever of 101 F, fatigue and muscle aches which lasted for 48 hours. Within 5 days patient began to experience exacerbation of essential tremor to the point that she experienced intermittent ataxia. Patient continues to suffer exacerbation of essential tremor.
This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot # J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 8 months 19 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Red swollen, burning and itchy eyes 10 hours after dose.  Benadryl 50 mg taken.   Eye swelling, redness, burning, itchy persisting into the next day. Another dose of medicine taken.  Low grade fever, headache, fattier Tylenol 1000 mg taken
RUNNY NOSE COUGHING FEVER ACHES PHLEM AND I AM STILL SICK.
1124  PFIZER COVID VAC. GIVEN, 1133 C/O FEELING DIZZY.  THEN C/O FEELING NAUSEATED WITH DRY HEAVES, PRESSURE IN RT. EAR AND HEADACHE: 1145. 1150 LOWERED TO THE GROUND, STATING SHE COULD NOT BREATHE.  EMS CALLED. EPI  VIA IM  (PEN) ATTEMPTED X3,  3RD DOSE SUCCESSFUL. EMS ARRIVED SHORTLY AFTERWARDS.
Swollen lymph nodes on neck, under chin, back of head, and in shoulder are. Entire arm very sore when she bends it - mostly joint pain.
Plain and inflammation of left arm in vaccine administration area; Plain and inflammation of left arm in vaccine administration area; Pain in both armpits; Weakness after 7 hours of administration; Dose received: 3/ dose number= 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 18Dec2021 at 15:00 (Lot number: S3025BD) at the age of 40 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; CETRIZINE and BREO ELLIPTA. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955, Anatomical Location: Right arm, Administration time: 14:00), administration date: 11Apr2021, when the patient was 40 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP7534, Anatomical Location: Left arm, Administration time: 14:00), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 at 15:00, outcome "unknown", described as "Dose received: 3/ dose number= 3"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE INFLAMMATION (non-serious) both with onset 18Dec2021 at 22:00, outcome "not recovered" and both described as "Pain and inflammation of left arm in vaccine administration area"; AXILLARY PAIN (non-serious) with onset 18Dec2021 at 22:00, outcome "not recovered", described as "Pain in both armpits"; ASTHENIA (non-serious) with onset 18Dec2021 at 22:00, outcome "not recovered", described as "Weakness after 7 hours of administration". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site inflammation, axillary pain and asthenia.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (first experienced when she was 21 years old and it developed 2 to 3 times a year since then).   On 9th July 2019, the patient received the 1st dose of Shingrix. On 9th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 9th July 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient reported pain at the injection site during administration of Shingrix in the left deltoid and said it lasted a few seconds and then resolved. For tolerance of 2nd dose, refer case US2020245637. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020245637:same patient
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.
Info has been received from an RN concerning a 4 year old female who on 6/24/02, at 12 months of age, was vaccinated, IM in the left arm, with the 1st dose of varicella virus vaccine live (lot 641794/0209M). The RN reported that on 10/11/05, the pt developed breakthrough varicella. Medical attention was not sought. The pt was treated with Atarax for the itching. The pt subsequently recovered from the breakthrough varicella. Additional info is not expected.
father phoned reporting event pt showed sign of stomach cramping, crying (no high pitched) temp <102 R; no convuls; no limpness or paleness; ER physician, dx as react to DTp & not to get w/pertussis any more only DT;
Gave 3 immunizations, about 3-4 min later fell to the right off chair, hit head on floor.  I helped her up.  She was twitching.  Felt dizzy, blacked out.  Layed her on table, took blood pressure (normal) gave juice. Felt fine afterwards (time 5 min)
Difficulty breathing, felt like throat was closing, epi and Benadryl given by EMS, transported offsite to nearest ER.
felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included PREDNISONE, ALLOPURINOL, ROSUVASTATIN CALCIUM (CRESTOR) and ADALIMUMAB (HUMIRA) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt tired). On 31-Mar-2021, FATIGUE (felt tired) had resolved. Not Provided          Treatment medications were not provided by reporter.   This case was linked to MOD-2021-090361 (Patient Link).
10/4/21 6pm Tingling sensation on soles of feet then on palms of hands ongoing high intensity for 24+hours then continuing a lower intensity on feet for 5+days; during first night sleep, whole body muscle spasms during the night causing pain which awakened from a deep sleep and resulted in body pain and fatigue upon awakening fully in the morning; 10/5/21 9am unrelenting nausea for 7 hours, non-responsive to prochlorperazine 10mg, leading to episode of vomiting at 3:00pm, then nausea responded at 7:00pm to Ondansetron 4mg;  also at same time on 10/5/21 9am intense, unrelenting excruciating headache, lasting 7+ hours at a high intensity level SUD=9 (Subjective units of distress as compared up against severe migraines which untreated are SUD 7-8 and where labor pains were 9), then intermittent headaches for 5+ days; during this time 10/5/21 9-6 stillness, lying without getting up for 7 hours due to intense pain; sickly pallor about 5 hours; loss of appetite 24+hours, and low appetite for 5+days; intermittent abdominal pain, diminishing in frequency and intensity over time 5+days; 10/6/21 night - complete insomnia for 8 hours;
On Sunday March 7, I experienced typical soreness and fatigue.  On Monday March 8, I started to feel muscle soreness and fatigue, primarily in my shoulders and other major muscles.  The soreness and fatigue grew progressively worse during the week, and peaked on Friday and Saturday, March 11 and 12.  On Sunday the 13th I felt somewhat better, with pain and muscle soreness primarily in my shoulders and large muscles in my legs.  The pain level has remained approximately the same since.  The pain is impacting my mobility.  Prior to the shot, I exercised on a regular basis but have not been able to exercise since.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site pain after receiving 1st dose of SHINGRIX vaccine. The event lasted for 3 to 5 days.
booster; Sore arm; COVID-19 Back; COVID-19 Back; Solicited report from the (redacted) by a consumer of a 26 year old male with events of non-serious SORE ARM AFTER THREE COVID VACCINE and COVID-19 BACK with HUMIRA (ADALIMUMAB). There was no reported medical history.  On an unknown date, the patient experienced SORE ARM AFTER THREE COVID VACCINE. In Nov2021, the patient experienced COVID-19 BACK. In 2021, the COVID-19 BACK resolved. On an unknown date, SORE ARM AFTER THREE COVID VACCINE resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On an unknown, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. On an unknown, patient received 3rd dose COVID-19 Vaccine manufactured by Pfizer. DID EVENT ABATE AFTER STOPPING DRUG?: NA Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of SORE ARM AFTER THREE COVID VACCINE and COVID-19 BACK was not provided.  CONCOMITANT DRUGS AND DATES OF ADMINISTRATION: Concomitant Drugs Not Reported  OTHER RELEVANT HISTORY: No relevant medical history Seq.No. : 1 Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB) Causality: 1)Vaccination site pain (Vaccination site pain) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge:  N/A  Seq.No. : 2 Drug : PFIZER BIONTECH COVID-19  VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN,UNKNOWN,UNKNOWN Daily Dose : 1)1st dose (1 in 1 Once) 2)2nd dose (1 in 1 Once) 3)3rd dose (1 in 1 Once) Route of Admin : 1)Intra-muscular 2)Intra-muscular 3)Intra-muscular Causality 1)Vaccination site pain (Vaccination site pain) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Possible Dechallenge :  N/A 2)COVID-19 recurrent (COVID-19) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A  2)COVID-19 recurrent (COVID-19) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge:  N/A; Sender's Comments: As per available information, the causal association between the events Drug ineffective, COVID-19 recurrent, Booster, and Pain in arm and the 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.
the patient received M-M-R II intrarnuscularly; no adverse symptoms reported; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status, lot number, expiration date, dose number and exact dose were not provided) intramuscularly for prophylaxis (incorrect route of product administration). No adverse events reported.
pt became pale & limp;T103;pt sat still staring & drooling for 3 days;mom called MD 28AUG97 told to get fever down w/APAP & keep eye on pt;mom felt shots caused brain damage;pt started rocking back & forth & head banging;autistic tendencies
2am fever, 4am call to pmd with 104 deg. F then taken to ER. Released with no further work-up. Next day temp 101 deg F. then seen in ER again, deteriorated-found to have purulent pericardial effusion.