chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute gastroenteritis symptoms, self limited, 4 hours after vaccination, fever 38.5, associated and shaking (not seizures). Treated with supportive fluids and acetaminophen.
R09.02 HYPOXIA 4/7/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
unexpected menstruation cycle; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (unexpected menstruation cycle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (unexpected menstruation cycle). At the time of the report, MENSTRUATION IRREGULAR (unexpected menstruation cycle) outcome was unknown.       Action taken with Moderna covid-19 vaccine( mRNA-1273 )was not applicable
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 15-OCT-2014 the patient was vaccinated with M-M-R II album status unknown (0.5 ml, subcutaneous; dose number and lot number unknown; EXP:13-SEP-2014). It was reported that the patient received an expired dose of M-M-R II. No adverse effect was reported. Additional information has been requested.
Aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 3 (booster), single (Lot number: 048L21F) at the age of 68 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose number: 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 2022, outcome "unknown", described as "Aches". Therapeutic measures were not taken as a result of pain. Additional information: However, it was also reported that the patient also received Moderna COVID 19 vaccine (Lot number: 088D21A) on 04Apr2022 (as reported, possibly discrepant, query sent) at 08:00AM as dose 4 in the right arm for COVID-19 immunisation. Patient received FLU vaccine on 09Sep2022 in the arm. The patient has no COVID prior vaccination and was not COVID tested post vaccination. The patient has no known allergies.
pt recv vax in lt deltoid 27MAY97 on 30MAY97 area red/swollen, inflammation;
Local rash, erythema, vesicles X 3 and temperature of 102.2F(AX).
Itchy welt on LT side of back, approximately 1/3" long, resembling poison oak. Welt double within approximately 2 days. Applying OTC cortisone cream, then calamine lotion 1-2 x/day, calmed the itch. I eventually searched internet for shingles/images-welt looked very similar.
On day of vaccination, patient developed a fever of approx 104 degrees.  The fever, along with inconsolable screaming/crying persisted for approximately 1 week.  At that time, patient had what appeared to be seizure-like behavior.  His arms were thrown back, his eyes wide and back arched.  Immediately after each seizure episode he would cry and spit up.  These symptoms lasted until approximately 2/12.
ADMINISTERED PAST CURRENT REFIRIGERATION BEYOND USE DATE AS LISTED IN EUA
The person who administered the vaccine went to high. Instead of injecting the medicine into my deltoid, she went much high in my shoulder. This immediately cause pain to shoot down my arm to my hand, index and thumb. This was done in my left shoulder.  Unrelated to the location and about 36 hours later I developed hives on my back, face, neck, legs and chest. Treatment for the pain and weakness included steroids and this dose didn't seem to help much with the hives. Maybe the hives would have been worse without the steroids. It's hard to say. I'm still experiencing the hives, pain and weakness 3 days after the flu shot was administered.
Absent minded; Doing things that are not my normal routine.  Reading messages incorrectly, taking wrong turns when I know the streets so well. I am a school bus driver, I know my route and made a few odd mistakes today. I am not distracted, I am not forgetful, I am just doing things that make no sense.
Cough/phlem /Phlem feels like it doesn't want to come up and it almost chokes; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Cough/phlem /Phlem feels like it doesn't want to come up and it almost chokes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027a21a and 30300161221a) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included BRINZOLAMIDE (AZOPT) from 01-Feb-2010 to an unknown date and TAFLUPROST (ZIOPTAN) from 25-Jan-2009 to an unknown date for Glaucoma, DILTIAZEM from 03-Jan-1986 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) from 06-Jan-1984 to an unknown date for Hypothyroidism, VEDOLIZUMAB (ENTYVIO) from 04-Jan-2014 to an unknown date for Ulcerative colitis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCTIVE COUGH (Cough/phlem /Phlem feels like it doesn't want to come up and it almost chokes). At the time of the report, PRODUCTIVE COUGH (Cough/phlem /Phlem feels like it doesn't want to come up and it almost chokes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: negative (Negative) Negative.         Treatment Information was not provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up was received and contains no new information.
Initial and follow-up information has been received for the Merck Pregnancy Registry for GARDASIL from a certified nurse midwife concerning a 22 year old female with depression, no pertinent medical history and no drug reactions/allergies who on 21-FEB-2007 was vaccinated with a first dose of GARDASIL (lot# 655618/0186U) 0.5 mL IM. On 22-AUG-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 658282/0929U) 0.5 mL IM. The patient became pregnant after two doses of GARDASIL. The patient's date of last menstrual period was 30-SEP-2007. Medical attention was sought. On 05-DEC-2007 an ultrasound was performed for dating and was viable 7.5 "fup" and on 31-JAN-2008 a maternal serum alpha-fetoprotein test (MSAFP) was performed and was within normal limits. No further information was available. The estimated date of delivery is 06-JUL-2008. Follow-up information was received the patient also had a history of papanicolaou smear abnormal. On an unspecified date the patient had anxiety and on 28-FEB-2008 CYMBALTA was prescribed. On an unspecified date the patient had gastrooesophageal reflux disease (GERD) and on 25-MAR-2008 the patient was given PREVACID. Additional information has been requested.
Fever, chills, sweats, loss of taste and smell as well as cough. Received her booster. Patient was not around anyone that has been sick and has not traveled.
Irregular menstruation (twice in one month) with heavy bleeding for more than 5 consecutive days each time.
Occured about 12hrs after vaccinations  blood sugars over 500 which she handled with her humalog "heavy" depression lasting for over 36 hours  did not go to dr or hospital.
Redness, swelling, malaise, diarrhea, inability to work due to symptoms. Localized reaction 3 inches left tricep.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient with no drug reaction/allergies. The patient's medical history included shingles "about two years ago". On 03-SEP-2014, the patient was vaccinated with ZOSTAVAX, 0.5 ml, subcutaneous. Lot number and expiration date were not reported. There was no concomitant medications. On 04-SEP-2014, the patient experienced injection site hard, swollen, red and warm. The outcome of injection site hard, swollen, red and warm was reported as not recovered. The patient sought medical attention; called to pharmacy. No treatment was given for adverse events. No lab diagnostic studies were performed. Additional information has been requested.
This is a spontaneous report from a contactable physician via a sales representative. A patient (age and gender unknown) received the first dose of PREVNAR13, USA, Lot Number: F75398, Expiration Date: October 2013). Suspension 0.5 MLX10 on an unknown date. Relevant medical history includes therapy regimen changed. The patient previously received four doses of PREVNAR on unknown dates. The physician noticed that the patient was only fully immune to one of the 13 PREVAR serotypes. The physician inquired whether he should administered another dose of PREVNAR13 to ensure immunization for the thirteen strains contained in PREVNAR13. The outcome of the event was unknown.  Information was subsequently reported from Product Quality Complaint Group (UPC/NDC#: 00005-1971-02). Description of Complaint: MD has a patient that was administered 3 doses of PREVNAR7 and a 4th dose of PREVNAR13. After conducting an assay MD noticed that patient was only fully immune to 1 of the 13 PREVNAR Serotypes. MD asked if he should administer another dose of PREVNAR13. Please send any and all pertinent information on whether MD should administer a 5th dose to ensure immunization for the 13 strains contained in PREVNAR13. Conclusion/Summary: The plant has reviewed all investigations associated with this batch from a manufacturing and technical perspective and all investigations were appropriately closed and addressed. No quality issues were identified in this review of batch related documents, review of release testing or inspection of retained samples. Retained samples meet the product description and the product is in date. No product was returned for examination and the product is not on stability. Follow-up (16MAY2012): Follow-up attempts completed. No further information expected. Follow-up (31MAY2011): New information reported from Product Quality Complaint Group includes: PREVNAR  product description: UPC/NCD#; lot number; expiration date; description of complaint.
Patient lists that she woke up during the night after receiving the vaccine feeling sweaty and feverish. Upon waking the following morning she took her temp and it was 100.8 and 101. Patient also reported injection site tenderness and localized redness.
This 85 year old  white male hospice patient received the Covid shot on   2/16/21 and went to the ED on 2/21/21  and was admitted  on  2/22/21 with  altered mental status, pneumonia, severe sepsis, bladder cancer, UTI, dementia and died on 4/19/21.  Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
Started with mild headache 2hours after vaccine shot, mild headache continued day 2-6, headache jumped to severe on day 7 & 8, 49 hours of severe headache, day 7 &8 also included symptoms of nausea & vomiting, other symptoms post shot included mild pain of muscle at injection site day 1-6, mild to moderate muscle soreness day 2-6, mild to moderate fatigue day 2-9, mild to moderate tiredness day 2-9, severe diarrhea day 6-9.
This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. On an unknown date the two patients were vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expired date were not reported) which were improperly stored. This was supported. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a pharmacy doctor student refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (lot # L027287 exp date 02-JUL-2017) (doses and route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient states she feels weak, dizzy and has the chills. Her arm is noticeably red and swollen, very sore and difficult to raise her arm. She was advised to contact her MD, and purchased BENADRYL and ADVIL before leaving pharmacy. Patient has no history of allergies to vaccines. Determined to be an allergy by MD!
Received Small Pox vaccination and approximately 4 days later noticed "another bump" (satellite lesionnext to vaccination site.  After 9 days post vaccination patient noted 3 "BUMPS" total around vaccination site.  Denies any pain but notes soreness at vaccination site;  visible erythema with minimal swelling locally.  No other complaints at this time.
Patient received vaccinations 6-9-10.  Slow progression of bilateral leg weakness.  Requiring urgent care visit 6/20/10 -> transferred to ER.
Per patient experienced pain in arm and neck after receiving injection. Per patient has difficulty moving his head to the side, feels stiffness and has to take an analgesic
Patient had COVID in October 2020 and was hospitalized for a few days due to  fever, body reactions and possible clotting. He was still required to get two vaccines (Moderna) and was sick with  high fever (102 degrees) for 2 days each time. Is it really necessary for people who had a  significant case of COVID  to get vaccinated twice. Seems like too much stress on the body in such a short time and maybe not even necessary.
low energy; fatigue; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis (Mild multiple sclerosis). Concomitant products included INTERFERON and CYANOCOBALAMIN (VIT B12) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ASTHENIA (low energy), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, ASTHENIA (low energy), FATIGUE (fatigue) and VACCINATION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Event outcome was updated.
DVT of femoral vein of left lower extremity, shortness of breath during exertion, cough, diaphoresis, malaise/fatigue, chest pain, flu-like symptoms, POX 96%, woke up at 3am 4/14/21 short of breath and wheezing with POX 94%, headache, dizziness only when short of breath, left leg pain.  Pt treated with Eliquis.
Information has been received from a Nurse Practitioner concerning a 26 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who in February 2009 was vaccinated with the first dose of GARDASIL with no problems reported.  The patient received the second dose of GARDASIL at the beginning of June 2009.  Concomitant therapy included hormonal contraceptives (unspecified).  It was reported that "three or four weeks after dose two", approximately on 21-JUN-2009, the patient developed nausea and abdominal pain.  The patient was seen in the office on 29-JUN-2009 regarding her nausea and abdominal pain.  An ultrasound, and computed axial tomography of the lower abdominal quadrant were performed (results not provided).  It was reported that "a month after the symptoms began", approximately on 21-JUL-2009, the patient had recovered.  Nausea and abdominal pain were considered to be disabling.  It was reported that the patient missed work for 1 week.  Additional information has been requested.  9/14/09 Medical records received DOS 8/25/08 to 8/27/09. Assessment: Abdominal pain. Patient presents with lower right abdominal pain and lymphadenopathy. Chills, nausea, diarrhea, constipation. Oral contraceptives.
Pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and CALCIUM, COLECALCIFEROL (CALCIUM VITAMIN D3 [CALCIUM;COLECALCIFEROL]) for Prevention.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Pt recv vax on 6/23/98; on 6/27/98 pt exp a major case of chicken pox of 60-100 spots.  Pt was irritable, temperature of 99-100 degrees.  On 6-30-98 pt had new eruptions.
Patient reported she had extreme vertigo that occurred the morning after receiving her first dose.  She could not sit up in bed.  She called her doctor and was told to drink a lot of water to keep hydrated.  A few days later she went to her doctor to get checked out.  The doctor prescribed meclizine.  The patient felt vertigo for 2 weeks, then recovered.
At 3:20PM, I looked up to see I only had 5 minutes left to leave and my heart started racing and I began to panic. My lips felt funny, my vision was a little weird. The nurse was called over and advised me I wasn't have an allergic reaction. She didn't want my heart rate to increase so she did not give me epinephrine. I drank water and sat  for an additional 20 minutes by that time I had already consumed at least 60 ounces of water.  I left the site feeling fine and began to notice my heart rate increasing again and my face and lips felt funny I couldn't make my mouth work when I attempted to drink water. I began to panic and went to the ER. They did bloodwork a chest x-ray an  EKG gave me a bag of fluid through the IV and advised me I was fine and I was released.
receiving only  the AS01B Adjuvant of Shingrix; receiving only  the AS01B Adjuvant of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 30th September 2021, the patient received Shingrix. On 30th September 2021, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional details were reported as follows: A patient receiving today only the AS01B Adjuvant of Shingrix (without the Lyophilized Component) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter consented to follow up.
pt recv vax 7MAY96 & 22MAY96 a pap test was abn & revealed possible dysplasia;7JUL96, pt was vaccinated w/2nd dose of varicella & became pregnant;
Mild body aches; Headache; Swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain.; Swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain.; This is a spontaneous report received from a contactable consumer (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number  EW0161 and expiration date: 31JUL2021) via intramuscular, on right arm, on 11Jun2021 at 17:00, (at the age of 56-year-old), as 2ND DOSE, SINGLE DOSE for covid-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. The patient had no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number:EW0151 and expiration date: not reported)  via intramuscular, on Left arm, on 21May2021 at 17:35,(at the age of 56-year-old) as 1ST DOSE, SINGLE DOSE  for covid-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine.The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. It was reported that on 12Jun2021, the patient spent the afternoon at a hot (90 degrees) and sunny festival. The patient came home and watched TV for several more hours of no symptoms. The patient noticed the swollen lymph node described as swollen lymph node in right armpit the size of 1/2 orange and some pressure and mild pain as the patient went to bed on 12Jun2021 at 19:00. On 13Jun2021, the next day, it was more painful and increased in pain, the 3rd day the patient finally took an ibuprofen. On 15Jun2021 at 17:15, it seemed to lessen in pain without drugs but the patient will probably take another dose to sleep. On 13Jun2021, the patient experienced mild body aches and headache. The patient underwent lab tests and procedures which included body temperature: 97.8 on 11Jun2021 and 98.8 on 12Jun2021. Therapeutic measures taken in response to the event headache included administration of Excedrin, 1 pill by mouth on 13Jun2021 and ibuprofen by mouth on 15Jun2021 and ongoing lymph node in right armpit the size of 1/2 orange and some pressure and mild pain. It was reported that the ibuprofen helped. No treatment was given for the event mild body aches. Outcome of the event Swollen lymph node in right armpit the size of 1/2 orange, and some pressure and mild pain was recovering and the events mild body aches and headache recovered in Jun2021.
On 2 April he received his fifth Anthrax dose and over the next 48 hours developed pain, redness, swelling, and itching around the vaccination site. He denies fever/chills, chest pain, headache, fatigue, malaise, arthralgias/myalgias, and generalized cutaneous and systemic symptoms. He has used cool compresses and yesterday took a dose of ibuprofen without benefit.
Child has a red spot on left arm. Appeared morning after vaccine. DX; Cellulitis. RX: Augmentin 600mg TID x10 days.
Headache, arm pain at site, dry eyes. Fever, chills, vomiting, fatigue, shakes, weak, dizzy.  Stabbing pain in left arm pit.
Purpuric lesions on lower extremities; arthritis lt knee & ankle; never developed hematuria, hematocheria or gastroenteritis; resolved over 7-10 days;
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. On 23-AUG-2015, the patient vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # K016005, expiration date 27-AUG-2016, dose and route of administration were not reported) (incorrect product storage). No adverse effects were reported. Additional information has been requested.