chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; chills; painful joints; swollen lymph node in left armpit (tennis ball sized); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Weak bladder" (unspecified if ongoing), notes: Weak bladder; "ADHD" (unspecified if ongoing); "Vit D deficiency" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN HCTZ; MONTELUKAST SODIUM; BUPROPION HCL; DEXTROAMPHETAMINE [DEXAMFETAMINE]; ALPRAZOLAM; MYRBETRIQ; ESCITALOPRAM; CETIRIZINE HCL; PROPANOLOL [PROPRANOLOL]; AMPHETAMINE SALTS; VITAMIN D [COLECALCIFEROL]; OMEGA 3 [FISH OIL]; FISH OIL. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 06Apr2022 at 10:30, outcome "recovering"; HEADACHE (non-serious) with onset 06Apr2022 at 10:30, outcome "recovering"; ARTHRALGIA (non-serious) with onset 06Apr2022 at 10:30, outcome "recovering", described as "painful joints"; LYMPHADENOPATHY (non-serious) with onset Apr2022, 40 hrs after the suspect product(s) administration, outcome "recovering", described as "swollen lymph node in left armpit (tennis ball sized)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills, arthralgia, lymphadenopathy.  Additional information: Reported that Approx. 24 hrs post vaccination - headache, chills, painful joints approx. 40 hrs post vaccination - swollen lymph node in left armpit (tennis ball sized). Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks: Olmesartan-HCTZ 20-12.5mg tab QD (Once a day); Montelukast Sod 10mg tab QD (Once a day); Bupropion HCl 150mg tab QD (Once a day); Dextroamp-Amphetamin 10mg tab PRN; Alprazolam 0.25mg PRN; Myrbetriq ER 25mg tab QD (Once a day); Escitalopram 20mg tab QD (Once a day); Ceterizine HCL 10mg tab QD (Once a day); Propanolol 10mg tablet PRN up to TID; Amphetamine Salts ER 20mg cap QD (Once a day); Vitamin D 1000 Supplement; Omega 3/ Fish Oil capsule. Prior vaccination, patient was not diagnosed for COVID-19. Post vaccination, patient had tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
achy creaky uncomfortable knees; achy creaky uncomfortable knees; achy creaky uncomfortable knees; sore arm; fatigue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 65-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, formulation; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included surgeries in knee, arthritis/ Joint inflammation, PMR (polymyalgia rheumatica) (7 to 8 years ago, and gets Prednisone shots in his knees, that helps with inflammation because PMR would turn the body on its joints and PMR went away in 1-2 years), ongoing Life-time abuse on both knees, ongoing multiple sport injuries, ongoing osteoarthritis in both his knees. The patient concomitant medications (other products) were not reported. The patient previously took prednisone for Joint inflammation. The patient experienced achy creaky uncomfortable knees, sore arm, and fatigue on an unspecified date in 2021. The patient stated that on the first shot it made his knees react badly too, like you are getting inflammation all over the body and his theory was that if you have a weakness in a joint, it was going to it and exacerbating it. The patient received second dose of bnt162b2 on 26Mar2021 at 05.00 (Batch/lot number: EP6955, Unknown dosage shot to her Upper left arm) for covid-19 immunisation. Treatment details not provided. The outcome of event reported achy creaky uncomfortable knees was not recovered and for other events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Awakened with an unusual type of headache. Different from usual headaches. Felt better later.
Initial report received on 14 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had previously received 4 doses of DAPTACEL; lot number C2657AA received on 06 September 2007, C2749BA received on 06 November 2007, C2760AA received on 04 January 2008 and C2955BA received on 03 November 2008 (routes and sites of administration not reported). The subject developed a cough on 01 July 2012, approximately three years and 8 months after the last dose. On 02 July 2012, he developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 01 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 17 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Itching at injection site, welt near injection site, swelling at injection site, redness surrounding injection site approximately 2 inches in circumference, itching on all of upper arm.
injection site knot; exhausted; chills; Joint aches and pain; body aches and pain; Headache; Nausea; injection site swelling; injection site redness; fever not over 100° F; unable to eat for days; injection site black and blue and hard; injection site was black and blue and hard; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard) and CHILLS (chills) in a 59-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.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DECREASED APPETITE (unable to eat for days), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness) and PYREXIA (fever not over 100° F). On 07-Jan-2021 at 3:00 AM, the patient experienced CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced INJECTION SITE MASS (injection site knot) and FATIGUE (exhausted). At the time of the report, DECREASED APPETITE (unable to eat for days), INJECTION SITE MASS (injection site knot), INJECTION SITE BRUISING (injection site black and blue and hard), INJECTION SITE INDURATION (injection site was black and blue and hard), CHILLS (chills), ARTHRALGIA (Joint aches and pain), MYALGIA (body aches and pain), HEADACHE (Headache), NAUSEA (Nausea), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (injection site redness), PYREXIA (fever not over 100° F) and FATIGUE (exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: (Negative) Negative results 09 Jan 2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache; I was weak; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiry Date/ UPC/ NDC number: Unknown), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for covid-19 immunisation. Patient's age at vaccination was 80 years. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient experienced headache and i was weak on 02Mar2021. Additional Context received as, the patient stated, "I got the vaccine, I got the first shot last month and I got the second shot on 01Mar (clarified as 01Mar2021), and I feel nothing on the 02Mar2021, I was okay. Then on 02Mar (not clarified), all of a sudden, I get a headache, not so bad but still a headache and today, in the afternoon, I was weak. I thought I had a fever but I have no fever, I just have a headache but now it is going away. Today, when I wake up, it was fading away and I got it in vaccination facility. When probed to clarify if consumer want to know that headache wais related to the Covid vaccine, consumer stated, as yes. For treatment in response to events, the patient stated, that was yesterday, today, I feel little better. No, I did not take anything. Outcome of the events was recovering.  No follow-up attempts are possible. No further information was expected.
mom called clinic 16SEP96 states pt recv vax 6SEP96 & 15SEP96 devel a rash 1st noticed on neck;spread to abd back were covered;smaller area of rash (red-raised on face arms & legs;no fever;eating well & nl behavior;MD felt rash r/t vax
Pt describes her arm as being red, swollen and hot. Stated her first dose was also similar nut with a 3/4 inch hard knot. Stated lasted about a week. When if the symptoms were going away she said yes.
The case was linked with the case number 2014SA011893. Initial report received from non-healthcare professional (patient's husband) on 26 January 2013. A 25-year-old female patient had received intradermally 1st dose of FLUZONE (INTRADERMAL, lot number: UT4728BA, expiry date: 30 April 2014) in the left forearm on 24 January 2013. The patient had no illness at time of vaccination and allergy to dairy product. On 24 January 2013, same day of administration the patient developed a large area of redness and swelling with raised red bumps at the injection site. Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by the sender: None. Follow up information was received from consumer on 27 January 2014. The cases were received on 21 March 2014 at GPV. It was confirmed that after hrs. 01.26.14 9:10 pm. Patient called regarding site reactions, the dose of vaccine was administered in the left forearm and not over the deltoid stated in the PI. Follow up information received from a health care professional on 05-May-2014: It was reported that the patient reviewed flair cleared up on it own after 5 days. The patient was recovered from adverse event on an unspecified date.
Severe base of neck and frontal head pain. Unable to sleep.  Lasted x 2 days;  01-18 & 01-19-21.
Pt's lower lip started swelling 1.5hrs after vaccine administration. MD diagnosed on 10/2/14 as fever blisters and patient has never had them before. Swelling has subsided as of 10/3/14.
Patient states right side of her neck is swollen and tender and has progressively extended up to her right ear.  Patient is an employee so brought patient to Store Director and they discussed options for seeing a doctor, sick leave, etc.
Blister on bottom of Left Foot in arch area, other very small red bumps in area, area is burning, sore and itchy.
7 days after vaccine:  swollen arm, fever in right arm, red itchy rash.  Taking Tylenol and applying Triamcinolone Acetonide Ointment 0.1%
patient reported redness, minor itching, and small bumps developing to the left upper arm, above the left elbow up to the shoulder.  Minor redness was noted, but small bumps were not observed by myself.  Offered benadryl but patient declined. Pt denies any difficulty breathing or swelling.  Provided cool compress.  Patient with mother, declines further observation, both state aware to seek medical attention if anything worsens, declines for medication attention to be called at this time, and patient and mother both state they wish to go home at this time - approx 1635.
Information has been received from a 75 year old female with no pertinent medical history and no known drug allergies who in approximately 2009 (reported as "about 2 years ago") was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck). Concomitant therapy included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown), and vitamins (unspecified). On 31-MAR-2011 the patient experienced shingles in her right buttocks one week after she had back surgery due to lots of pain in her left buttocks and her physician said it was probably caused by the stress of the surgery. The patient was treated with VICODIN for pain from the back operation, and steroid pack for 6 days, ZOVIRAX cream and pills. There was no lab diagnostics performed. At the time of the report, the patient's rash was gone but she was still in some pain. Upon internal review, pain in the left buttock, requiring back surgery, was determined to be an other important medical event. No further information is available.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.96.  Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient received Janssen COVID vaccine on 3/14/21. On 1/12/22, patient admitted to our inpatient med/surg unit with femoral-popliteal bypass stent occlusion (acute on chronic numbness of right foot which is cool to touch, and signs of recurrent multivessel arterial occlusions). Patient was also found to be COVID positive upon admission (not hypoxic). Patient underwent right axillary artery - profunda femoral artery & femoral - below knee popliteal artery bypass on 1/14/22,  then transferred to CCU post-op (hypoxic respiratory failure postoperatively in the setting of enlarging pneumothorax s/p left thoracentesis), IR chest tube placement 1/14/22, then transferred back to med/surg unit on 1/16/22. As of today (1/18/22), patient is still admitted in our med/surg unit.
No additional AE reported; a patient received the first dose of GARDASIL 9 on 24 MAR 2016 and was 19 years old at the time. Caller reports that the second dose was administered today 14 SEP 2021; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown exact age. There was no information regarding the patient's medical history, drug reactions/allergies or concomitant therapies provided.  On 24-MAR-2016, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. The patient was 19-year-old at that time. On 14-SEP-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # T039467, expiration date 20-MAY-2023 (route of administration was not provided). It was considered to be an inappropriate schedule of vaccine administration. No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T039467; expirationdate: 20-MAY-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient received a COVID vaccine that had been out of the refrigerator for longer than 12 hours. No adverse reaction reported.
On the evening of 1/24/2021, I noticed a small rash on my right arm at the site where I received the vaccine injection.  On 1/25, the rash spread, was bigger, redder in color, raised/bumpy, and itchy.  I applied Hydrocortisone throughout the day.  On 1/26, the rash had the same appearance in color and spread further down my arm.  I did not apply anything.  On 1/27,  the rash was lighter in color, less itchy, and the size was the same.  I saw my doctor thru a TeleHealth visit.  My doctor consulted with  her colleague and advised me that it was a delayed (2-week) allergic reaction of the vaccine, I am able to get the second dose of the vaccine and to be observed longer, at least 30 minutes after the second dosage.  Today, 1/28, the rash is significantly lighter in color, flatter, and has not spread.
Nightmare on 6/4, persistent chest pain since 6/5. Pain is 4 on the scale of 10 as indicated by the child on 6/7. Going to see doctor on 6/8. Looks fine though.
Patient called pharmacy 3-4 hrs. following vaccination and reported swelling & tenderness in left arm. Follow-up following morning patient reported improvement in symptoms.
nausea; being dizzy; soaked in sweat; hunger; muscle pain; vominting; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain) and VOMITING (vominting) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ALPRAZOLAM (XANAX), QUETIAPINE FUMARATE (SEROQUEL) and VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Product used for unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain), VOMITING (vominting), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced NAUSEA (nausea). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (being dizzy), HYPERHIDROSIS (soaked in sweat), HUNGER (hunger), MYALGIA (muscle pain), VOMITING (vominting), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: 2nd dose details and outcome of the events updated.
This spontaneous report as received from a other health professional (Registered Nurse) refers that on herself of age a 84 years old. The patient explained that she developed bilateral pneumonia on 30-MAY-2012 after receiving 0.5 ml PNEUMOVAX 23, 2-3 year ago (approximately on 2009). Concomitant medications included: possible received influenza virus vaccine (unspecified) concurrently (approximately on 2009). On an unknown date, computed tomography scan was performed (results not provided). The patient sought medical attention. The patient stated that she was given LEVAQUIN as treatment which "sucked up her muscles" to the point that she could hardly walk. The outcome of these events were not provided. On an unknown date, the patient recovered from bilateral pneumonia. The relatedness for bilateral pneumonia was unknown for PNEUMOVAX 23. The reporter considered the event bilateral pneumonia to be disabling. Additional information has been requested.