chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired and sleepy; tired and sleepy; received third dose but he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received third dose but he is not immunocompromised), SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 039K20A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Jan-1992 and High cholesterol since 15-Jan-2015. Concomitant products included EPLERENONE from 15-Jan-2015 to an unknown date, AMLODIPINE from 15-Jan-1992 to an unknown date and HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) from 15-Jan-1992 to an unknown date for Blood pressure, ATORVASTATIN from 15-Jan-2011 to an unknown date for Cholesterol, MELOXICAM from 10-Oct-2011 to an unknown date for an unknown indication.   On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced OFF LABEL USE (received third dose but he is not immunocompromised). On an unknown date, the patient experienced SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy). At the time of the report, OFF LABEL USE (received third dose but he is not immunocompromised) had resolved and SOMNOLENCE (tired and sleepy) and FATIGUE (tired and sleepy) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: follow-up Information Included patient demographic details, Concomitant medication, concurrent condition and new event added.
Info has been received from an RN concerning a 12 month old female who was vaccinated MMRII (lot 648664/0992P). Subsequently, the pt developed a rash on her arms and legs approximately 2 weeks after vaccination. Treatment for the rash included Benadryl. At the time of the report, the pt was recovering. Additional info has been requested.
fever; ache;  This is a spontaneous report from a Pfizer-sponsored program.  A contactable nurse and  a 70-year-old female patient reported  that she received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation and palbociclib (IBRANCE), oral from Apr2020 (Batch/Lot number was not reported; Expiration Date: 31May2022) to an unspecified date, at 125 mg, 1x/day(for 21 days) for breast cancer.   The patient medical history was not reported. Concomitant medications included calcium carbonate (CALCIUM CARBONATE) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported; letrozole (LETROZOLE) taken for an unspecified indication, start and stop date were not reported; vitamin C [ascorbic acid] taken for an unspecified indication, start and stop date were not reported.    The patient previously took naproxen and experienced hypersensitivity.    The patient experienced fever (non-serious) on an unspecified date with outcome of unknown , ache  (non-serious) on an unspecified date with outcome of unknown.  The action taken in response to the events for palbociclib was unknown.
Rash, hives: legs, back, belly, arms, face, eyelids, around mouth, neck, genital area. I had 3 episodes of hives/rash. one daily after day of vaccination.  I had to go  to ER the day I received vaccine.  (i received the vaccine at the  Hospital  where I work ( in the Lab),  went that same night to the ER  where I also work in the Lab .  I was given i.v. benadryl and 2 other medications. Later I was given a prescription for  Prednisone  5 days and Atarax after being released. The second day I got worse.  Third day symptoms subsided. Now it is 8 days after,  I have only a small rash in my leg.
Parkinson is worse since the vaccine; both hands shaking; Is itchy in all my boy, still itchy; A spontaneous report was received from a healthcare professional who a 86 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching all over my body and Parkinson's is worse since the vaccine.  The patient's medical history included Parkinson's disease. Products known to have been used by the patient, within two weeks prior to the event, included pramipexole.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, two days post vaccination, the patient reported he had itching all over his body. He was unable to sleep without taking diphenhydramine due to the itching.   On unknown date, the patient also states he thought the vaccine made his Parkinson's worse. He reported  both of his hands had been shaking since he received the vaccine.   Treatment for the event included diphenhydramine and pramipexole.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events itching all over my body and Parkinson's is worse since the vaccine, were considered unknown.; Reporter's Comments: This case concerns an 86-year-old, male, with medical history of Parkinson's disease, who experienced a serious event of Parkinson's disease aggravated after receiving first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Follow-up information is expected.
post vaccination patient lost consciousness for a few seconds began to sweat shallow breathing became alert complained of unsteady feeling remained seated took sips of water refused acetaminophen slowly recovered becoming alert and exited to a waiting area to be with family time range about 15 minutes family exited after 15 more minutes post event phone contact patient was recovered after water and Tylenol at home and without complaint committed to a follow up vaccination after 21 days
Woke up on the morning of the 21st with a sore throat. On about the 25th, the sore throat was better, but I now have chest congestion. Treating with over the counter medication (Mucinex DM).
Vaccine not removed from freezer at 2 wk mark- at 3 wks and administered after consult with Imm/manf., notified pt offer repeat dose
Vaccine given beyound 30 days of refrigeration period; Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) and PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was 267 pounds.  No concomitant medication were reported No treatment medication were reported   This case was linked to MOD-2021-313106 (Patient Link).
This is a spontaneous report received from contactable consumer or other non-HCP (LRN4386547). A 15-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 15, on Jul 20, 2021, single dose, for COVID-19 immunisation. The patient's medical history not reported. Concomitant medication included Evrysdi. The patient experienced fatigue/tired, onset Jul 2021, with outcome of unknown; and rhinorrhea/sniffles, onset Jul 26, 2021, with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Caller states she received her first dose of the vaccine 8 days ago and two days ago she developed a swollen lymph node and a "hive like" itchy red area  at the injection site. Caller denies that its spreading but states it is warm to touch. Advised caller to contact her PCP so he/she can evaluate and to draw a ring around the borders to assess if it is spreading.
Right upper arm became red and swollen.  Abx given by dr...that's all I know...reported through our internal ADR/med error reporting system.
Pt came in late in the evening of 11/17/08  to say that her vaccinated arm was hurting, that there had been since the time of the injection a sharp and constant pain.The site of the injection was unremarkable and did not appear swollen or bruised. She has not sought out additional medical help.
Itching close to the site of the vaccine on the arm, been going on for a day and a half. Hard mass on arm, redness and skin warm to touch, on the arm under the shot site. There is a hive that measures about 4-5 inches . This happened with the second dose.
Patient came into the Pharmacy at approximately 3pm on 11/4/2016.  She showed me her arm which had redness on her upper arm, but little to no swelling. She then showed me a picture of her arm the day after she received the shot and it was red and inflamed. She also stated that she had to use her inhaler because she had trouble breathing. She told me that she was fine now and had no lingering effects except for the slight redness. She was just wanting to know if she should take a flu shot the following year.
The dose for the Moderna vaccine is 0.5 mL. The patient inadvertently received an extra 0.01 to 0.02 mL. The manufacturer instructed us to contact the patient to inform them the excess dose could potentially lead to side effects that could be local or systemic. No serious adverse events were experienced by the patient.
Information has been received from a certified medical assistant concerning a female patient who was vaccinated (date unspecified) with MMR as a child. On 3/31/05, the patient's titer was negative for rubella. No additional information available at this time. There was no product quality complaint involved. Additional information has been requested.
Ptr received a Jannsen vaccine 3.09.21 at med Center; Pt went to Drive-Through and received Moderna Dose 1; He was not asked if he had a prior vaccination Pt arrived at Walk-in wanting, and scheduled for Moderna Dose 2; When facility learned of Pt's 2 vaccines, a thrid was NOT provided
The MA who gave patient his vaccine today called me to assess the vaccine site. I went in to see the patient and his twin brother and parents. Apparently after receiving his MMR vaccine patient developed a pea sized hematoma surrounded by a nickel sized reddened induration on his right thigh. I had the MA get some ice for the area and alerted the clinic "Hot Doc", Dr. who came in to assess the child. Upon her arrival the parents reported that patient also had hives on his chest and back. Dr. was great and took the time with the parents to explain what to do. The child will return to clinic tomorrow with one of our NPs for reassessment.
No additional AE; An expired dose of VARIVAX was administered to a patient; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. No information on patient current condition, medical history and concomitant medications was provided.     On 03-APR-2023 the patient was vaccinated with one dose of expired varicella virus vaccine live (oka/merck) (VARIVAX) lot# U010399 and expiration date 01-APR-2023, for prophylaxis (exact dose and route of administration was not provided) (expired product administered and no adverse event).
Pain in back and high stomach area for 2 weeks.  Ultimately resulted in aorta pulling away from stomach and causing repaired aneurysm to rupture.
The day after my first vaccination woke up Tuesday with the whole left side of body in severe pain, left eye swollen shut. By Wednesday I felt more normal.
I have had severe nausea every single day since the vaccination. It gets worse after I eat food. I begin to gag. I?ve also had diarrhea and loose stools.
Patient's eyes began to burn, experienced dizziness  and lip tingling/swelling. Patient also experienced fever, diarrhea, vomiting.
red itchy area @ inject site approx 10cm in size; no hives or rash; pt c/o itchy felling; ``can I scratch my arm''
Myoclonus in upper extremity during morning. Started the day post 4 month shots. No prescription.
Swelling, hot to the touch, redness, rash and hives at injection site.
A non-serious spontaneous report of mouth numbness has been received from a registered nurse concerning a 49-year-old female subsequent to H1N1. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST intranasally on 28-Oct-2009. On 28-Oct-2009, after H1N1 administration, the patient experienced mouth numbness. On 28-Oct-2009, after several hours, the event of mouth numbness resolved.
difficulty sleeping (due to the itching and rash); hives, and it's all over her body including between her fingers; left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing; left arm itching/ severe itching ongoing; "got sick"; fever; chills; body aches; swelling of face; swelling of ears; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included No adverse reaction. Concurrent medical conditions included Drug allergy (doxycyclline).   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), SWELLING FACE (swelling of face) and EAR SWELLING (swelling of ears). On 05-Jun-2021, the patient experienced RASH (left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing). On an unknown date, the patient experienced INSOMNIA (difficulty sleeping (due to the itching and rash)) and URTICARIA (hives, and it's all over her body including between her fingers). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (left arm itching/ severe itching ongoing), ILLNESS ("got sick"), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches), SWELLING FACE (swelling of face), EAR SWELLING (swelling of ears), RASH (left arm rash/ rash continued all over her body (including ears, neck, chest, back, and legs)/ rash ongoing), INSOMNIA (difficulty sleeping (due to the itching and rash)) and URTICARIA (hives, and it's all over her body including between her fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    no concomitant medications reported. treatment medications included steroids injections.
Flu vacc on 10/3, RICA redness size of quarter 10/4. On 10/5 measured 60 mm across/30 down. Large in day increased to 70 mm across 35 mm down. RX for KEFLEX 500 mg QID x 10 days. Arm slowly improved.
Per Pt, after the shot was given he developed a large hard knot in the deltoid region. He treated with BENADRYL and TYLENOL. Pt stated the knot softened overnight and developed redness, pain, and swelling on inside of upper arm. Pt phoned PCP physician 10/19/18 and prescribed Cephalexin 500mg three times a day for 7 days. At pharmacy patient discussed reaction w/pharmacist. Pharmacist observed bright redness covering the inside of left arm from a few inches below armpit to elbow area. Patient stated he discussed symptoms of reaction w/physician off. He also discussed w/office that he has developed a "runny nose". F/U pt call 10/20/18 11:15AM, Pt states arm is still red, - swelling and pain some better.
Two weeks after the second vaccine really bad rash on my face broke out and eye brows loss hair, saw dermatologist diagnosed it as dermatitis provided topical cream.
1 hr after vaccines were administered, pt with fever and fussiness. Decreased appetite. Continued for >48hrs.
Within  5 minutes pain @ site with swelling, redness and pain.  Then 1 hour  some hives @ site. The next day extremely tired and slept the entire day.But
Started experiencing a bad headache behind the right eye on Wed 1/27 at night, and on Feb. 7th could not get out of bed, his left shoulder blade became so painful went to the ED Feb. 8.  Sent home the next day.  The pain was so bad he thought he was having a heart attack.  Took NTG did not help.  Returned to ED on the 10th - stayed in in hospital for 8 days.  Specialists were seen and nothing could help with the pain.  Consulted with cancer doctors, and neurologists, doing tests to diagnosis. Dr. gave a nerve block and a week later the pain started to get better a week later on a holiday. Pain still comes and goes.  Pain Started getting worse today 4/23/21.  Must lie down on right side to get any relief. Has lost 50 pounds is very weak and getting weaker every day. and it is very painful to walk 40 steps to the garage.  The TENS unit is not helping with the pain.   Getting a spinal test.
Information has been received from a registered nurse concerning a 69 year old female (187 pounds) with no illness at the time of vaccination and allergies to penicillin, tetracycline, cephalosporins and ZITHROMAX who on 28-JUN-2007 was vaccinated subcutaneously with Zostavax (Oka/Merck) (lot # 657764/0584U).  On 29-JUN-2007 the patient developed a cellulitis hypersensitivity reaction to Zostavax (Oka/Merck).  The patient was prescribed CIPRO, 500 mg twice a day for 7 days and loratadine, 10 mg daily as needed.  Additional information is not expected.
Herpes zoster vaccination is documented as being given in the left deltoid however, patient reported redness in the right arm that extended from the shoulder to just below the elbow. Nurse reported area was hot to the touch. Veteran was told to alternate acetaminophen and ibuprofen, and to also take diphenhydramine. Symptoms: Erythema Multiform, Urticaria Pruritus.
2:30pm on 10/23 - pain/weakness in right leg, she was limping but still walking 4:00pm on 10/23 - leg pain became worse where she needed to be carried  8:00pm on 10/23 - slight fever of 100.3, 7.5ml Tylenol given for fever and leg pain 12:30am10/24 - she woke up crying. Fever was 103.8. Leg pain severe. Facial swelling of eyes and lips. Complaining of headache pain, tongue pain, and body pain. She was taken tj the ER. 1:00am 10/24 - ER checked her for anaphylaxis. Her airways and breathing/heart were fine. Administered 7 ml of Motrin  for fever and pain. Er doctor told us reaction was likely vaccine related and should be reported.  10/24 9am - fever and leg pain  continues, swelling has gone down. Continued treatment with Tylenol and Motrin.
Developed amenorrhea for1 year after receiving AVA #2. Also developed motion sickness that persists to the present. 1 year later developed fibromyalgia/chronic fatigue syndrome. Symptoms: fatigue, malaise > 60 days, amenorrhea, nausea - motion sickness, diarrhea, constipation, dizziness, cognitive deficiency, dyspnea (shortness of breath), numbness left side of body.
Narrative: COVID infection following COVID vaccine series 03/05, Pfizer, dose #1 03/29, Pfizer, dose #2 08/13 pt cc: chills, cough, diarrhea, fatigue, headache, myalgias, dyspnea, exposure: friend 08/31 COVID swab, result: detected 09/21 COVID swab, result: not detected
red, feverish spot on lt deltoid the size of a quarter on onset inc in size to 3inches in diameter above & below inj area;sl puffy & swollen;
Case received from a healthcare professional on 14 October 2010 under the local reference number 10-0732. A 35-year-old female patient, with no illness at time of vaccination, no known allergies, no relevant medical conditions and no other medications, had received her 1st subcutaneous dose of YF-VAX, batch number UF798AA, in the left arm, on 08 October 2010. The patient had no reported adverse reaction following prior vaccination. On 11 October 2010, i.e. 3 days post-vaccination, the patient experienced a swollen area on the left neck. She was seen by a physician on 14 October 2010 who reported a 1-1.5 cm tender lymph node in the left lower neck. There were no other reactions. The patient's symptoms were not resolved at the time of the report. Documents held by sender: none.
Major skin reaction; This is a spontaneous report from a non-contactable physician received via a sales representative.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced major skin reaction on an unspecified date with outcome of unknown.  Event took place after use of product.   No follow-up attempts are possible. Information about lot/Batch number cannot be obtained. No further information is expected.
Pt came to ER c/o difficulty breathing, wheezing, and cough.  Onset 3 days prior.  Covid positive rapid test completed 8/3/21.
Experienced spinning in the head; Pain all over body,Unable to move due to pain; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Experienced spinning in the head) and PAIN (Pain all over body,Unable to move due to pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Cancer and Asthma. Concomitant products included GABAPENTIN and VERAPAMIL for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VERTIGO (Experienced spinning in the head) and PAIN (Pain all over body,Unable to move due to pain). At the time of the report, VERTIGO (Experienced spinning in the head) and PAIN (Pain all over body,Unable to move due to pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.    This case was linked to MOD-2021-095210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up information was received on 28-MAY-2021 and it contains no  significant inforamtion