chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered the Moderna COVID-19 vaccine to a 17 year old; A spontaneous report was received from a pharmacist concerning a 17-years-old, female patient who received Moderna's COVID-19 Vaccine, and who was administered the Moderna COVID-19 vaccine to a 17-year-old.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19 Jan 2021, Pharmacist administered the Moderna COVID-19 vaccine to a 17-year-old.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event administered the Moderna COVID-19 vaccine to a 17-year-old was considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
Medications Prior to Admission Medication Sig Dispense Refill Last Dose ? aspirin 81 MG PO Chew Tab take 81 mg by mouth once every other day.     6/4/2021 at Unknown time ? docusate (COLACE) 100 MG PO Cap take 100 mg by mouth as needed for FOR CONSTIPATION.     Past Month at Unknown time ? insulin 70/30 (NovoLOG) (70-30) 100 UNIT/ML SQ Suspension Sliding scale twice daily with meals     6/4/2021 at Unknown time ? latanoprost (XALATAN) 0.005 % OPHTH Solution place 1 Drop into both eyes once every night at bedtime.     Past Week at Unknown time ? methocarbamol (ROBAXIN) 750 MG PO Tab take 750 mg by mouth every 8 hours as needed for FOR MUSCLE SPASM.     Past Week at Unknown time ? Alirocumab (Praluent) 75 MG/ML SQ Solution Auto-injector inject 75 mg as directed every 14 days. 3 mL 3 5/31/2021 ? amLODIPine (NORVASC) 10 MG PO Tab TAKE 1 TABLET BY MOUTH EVERY DAY 90 Tab 1 Past Week at Unknown time ? Insulin Syringe 31G X 5/16" 0.5 ML XX Misc Twice daily for insulin injections. 100 Each 3
chills; generalised body aches; tiredness; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (tiredness), CHILLS (chills) and MYALGIA (generalised body aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20a) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included ASA for Analgesia, OMEPRAZOLE.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced FATIGUE (tiredness). On an unknown date, the patient experienced CHILLS (chills) and MYALGIA (generalised body aches). On 11-Jan-2021, FATIGUE (tiredness) had resolved. At the time of the report, CHILLS (chills) and MYALGIA (generalised body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient had shingles vaccine 1month prior to Moderna covid-19 vaccine at her right arm through route on 30-11-2020. patient using osteo bi flex
Burning sensation intermittently on 3 occasions inside left arm; Burning sensation intermittently on 3 occasions inside left arm. It felt like an electric shock or jolt.; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: En6200), via an unspecified route of administration in left arm on 23Mar2021 at 13:00 (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. No other medications received in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 18:00, the patient experienced burning sensation intermittently on 3 occasions inside left arm and it felt like an electric shock or jolt. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The clinical outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: events details added (no treatment received), events were recovered in 2021.
Vaccine reaction w/swollen and redness on (B) arms. MOTRIN and BENADRYL were given. ((L) 4/2 cm (R) 10x11 cm) & cold compression.
no adverse event; PROQUAD had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2023, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # X011437 exp date 18-JUL-2024) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Morning after vaccines given, youth develop violaceous & pink splotches/rash over right side of face, ear - warm to touch & pruritus on bilateral arms & slight  increased redness to bilateral legs.
Patient reports redness, swelling, and tenderness at the injection site (L) arm deltoid area., treated with cold compress, will continue to monitor, does not interfere with ADLS.
arm became red, swollen, and very painful-lasted for about 4 days then gradually improved
Observed minimal site swelling and moderate heat at injection site of HPV#1.  Patient c/o pain at injection site.  Mom stated only one dose of Tylenol given after injections given for pain but none since that time.
12/13/22 presents to ED for "chest pain, dyspnea". PMHx of "CAD s/p stents x3, HTN, HLD, type 2 diabetes mellitus"
Aches; headache; chills; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 14:30 (Lot number: FC3181) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; PRILOSEC [OMEPRAZOLE].  The following information was reported: PAIN (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "Aches"; HEADACHE (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "headache"; CHILLS (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "chills"; PYREXIA (non-serious) with onset 19Aug2021 20:00, outcome "recovered" (Aug2021), described as "fever". Therapeutic measures were not taken as a result of pain, headache, chills, pyrexia.  Additional information: Most recent COVID-19 vaccine was administered at the hospital facility. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient received Lisinopril, and Prilosec within 2 weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
I had two shots doesn't work for me/suspected vaccination failure; doesn't work for me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 shots of Shingles vaccines and they did not work for the patient. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
patient became diaphoretic, had involuntary muscle movement, non verbal for 4-5 seconds.
This 86 year old female received the Covid shot on  3/10/21    and went to the ED and admitted on  3/12/21 with the following diagnoses listed below. J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified Altered Mental Status
On Jan 28, the day after shot, I experienced light menstrual bleeding. It went on for 4 days.
Information has been received from an NP concerning a male who had titers drawn in 3/98 which were positive for mumps and rubella and negative for Rubeola. On 3/25/98, the pt was vaccinated with MMRII. The pt was vaccinated again on 4/17/98 with MMRII. Titers were drawn again and showed that he was negative for Rubeola. A 3rd dose of MMRII was given on 11/3/00. Additional information has been requested.
Fever up to 100.8 degrees F, headache, body aches, fatigue, lethargy
This spontaneous report as received from an office manager (registered nurse, R.N.) refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On an unknown date, the patient received an improperly stored dose of PROQUAD injection (dose, frequency, route and lot number were not reported). Concomitant medications were not specified. No symptoms reported. Additional information has been requested.
Vaccine had was prepared the previous day at 10:00 am and  was administered the next day at 2:30 pm.  This was past the 6 hours of viability of a diluted vaccine.  No adverse reaction noted.  Provider recommended repeating the dose in 3 weeks and 3rd dose be administered 3 weeks later.
I had my first dose of the Pfizer COVID-19 vaccine on Tuesday, April 27, 2021.  On Wednesday morning, April 28th, I noticed that my knees we swollen.  As the day progressed, I became tired and vacillated between being chilled and hot.  I did not have any other symptoms.  On Thursday, April 29th, I noticed that my clothes were fitting very snug.  It appears that the COVID-19 vaccine has caused my body to become swollen.  To test this theory, I put on a pair of pants that I wore on Monday, April 26, 2021, which were baggy.  And the same pants are tight.  I am scheduled for my second dose of the COVID-19 vaccine on May 18, 2021.
Mild fever 100.2; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 10Feb2021 15:45 as 2nd DOSE, SINGLE for covid-19 immunization at work-place clinic (43 year at the time of vaccination). It was reported that previously on 20Jan2021 the pa-tient had her BNT162B2 (Solution for injection, Lot number unspecified) via an unspeci-fied route at 1st DOSE, SINGLE for covid-19 immunization. The patient was healthy before the vaccination. The patient medical history was not reported. Concomitant medication included centrum vita-mints (biotin, calcium pantothenate, chromic chloride, colecalciferol, cyanocobalamin, dl-alpha to-copheryl acetate, folic acid, manganese sulfate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, sodium ascorbate, sodium molybdate dihydrate, sodium selenate, thiamine mononitrate, zinc oxide) taken for an unspecified indication, start and stop date were not reported. On 11Feb2021 05:00AM, the patient had his body temperature checked and results show mild fever 100.2 along with headache. The patient did not receive any treatment for the events. The patient also reported that since the vaccination the patient had not been tested for COVID-19. The outcome of the events was reported as recovered on an unknown date at the time of report.  No follow-up attempts are possible. No further information is expected.
05/09/2022-Two episodes of giddiness, nausea, aphasia; each episode lasted a few seconds (less than 5). 8/31/2022-Four episodes of giddiness, nausea, disorientation, aphasia (one episode); olfactory hallucination (two episodes).  Each episode lasted only a few seconds. No treatments as of this date.
This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 17-year-old patient who received PEDIARIX. On 21st October 2014, the patient received PEDIARIX. On 21st October 2014, an unknown time after receiving PEDIARIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: PEDIARIX was administered to a family instead of flu vaccine. Family members were 17, 15, 11 and 6 years of age. No other information was provided.
INITIAL SORENESS SPREAD TO BACK, VOMITING HEART BURN DIARRHEA HEADACHE AND FEVER BEGAN 3/13 IN THE EARLY A.M. CONTINUED THROUGH SATURDAY.  FEVER ON AND OFF SUNDAY AND MONDAY.
I had Tachycardia, high blood pressure and my oxygen levels when down while at rest. I had pressure in my chest. I called my doctor and she put me out of work for a week, I monitor my blood pressure, oxygen and she said not to doing anything.
It was around 8:00pm on 05/25/2021 I was working at my job. My boyfriend was like you don't look good he said I had dark purple circles under my eyes and that inside my inside it looked yellowish reddish. I was walking but everything was spinning at the same time. The whole time I was trying to convince myself that I was feeling good and that I was okay. But I was like yeah I don't feel good at all. My job requires me to deliver packages but my boyfriend was like just sit down I'll do it for you. As I sat there people would come in and out of the elevator they looked all strange it was like I was hallucinating I felt like I was on drugs I was seeing things. I was seriously scared for my life I couldn't drive myself back home of course. I got home and kept going it last about 5hrs. Then I woke up like around 3am and was having a higher fever of 105.4 I took some medicine then when back to sleep but I had to get back up immediately as everything started spinning and I felt so nauseous. Then around 5am I started throwing up and threw up 4 times but it was just that yellow acid. I kept up with my medicine every 4 hrs. As the week when on and still to this day I just space out like I forget everything.
This spontaneous report was received from a nurse and refers to a 19-month old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 26-JUL-2018, the patient was vaccinated with improperly stored VAQTA lot # of R007388 with expiration date on 27-MAY-2019 (dose, route and site of administration were not reported) for prophylaxis. It was unknown if the sterile diluent used for reconstitution was properly stored. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 72 hours and range above 32 up to 35 degrees Fahrenheit for 72 hours. There were no previous temperature excursions reported. No adverse effect was reported. Additional information is not expected. Sender's Comments: US-009507513-1810USA000253.
Experienced a retriggering of concussion symptoms: intense head pain, vision issues, nausea.
I developed a large rash on my left arm a little over a week after the injection. It is still itchy and red but not as swollen today-almost a week after it developed.
On 2/4/2023 - woke up with itchy rash on arms. By mid-afternoon on 2/4/2023, the rash had spread to neck, back, torso, and ankles.  Rash continued to expand/ was warm to touch/very itchy. By midnight, 2/4/2023,  rash had spread to scalp and side of face, and all of feet,  and covered 80% of body. Experienced some dizziness and difficulty breathing at this time.  By morning on 2/5/2023, the rash had receded somewhat although it now appeared on the legs. The texture of the rash also changed to a more "blotchy"  appearance. Rash at this time covered 50% of body, but began to appear on face. The rash was not as itchy as day before. By 2/6/2023, rash had receded from scalp, face, and now covered portions of arms and chest - approximately 25 % of body. Wash also less itchy. By 2/7/2023, minimal redness on arms and stomach area. By 2/8/2023, rash had disappeared and no symptoms.
Slight fever over night. By 4 on 10/3 a rash had broken out in the injection are. Rash was extreme itchy. Injection area ightly swollen. Intense full body muscle aches by 10am on 10/3
ADMINISTRATION ERROR : Pt. received a 3rd Booster of Phizer 08/17/2021, Previously received 1st Moderna 04/15/2021 & 2nd Moderna 05/15/2021. No known symptoms at the time.
Acute onset peripheral non-infectious keratitis involving her left cornea with no prior illness or eye conditions, treated aggressively with topical corticosteroids.  This resembled an acute auto-immune inflammatory condition.  Patient has recovered under my care.
Fever up to 104 degrees Fahrenheit; Headache; Watery diarrhea for two days; Mental confusion on day 3 of illness; Admitted to hospital on day 3 and treated with antibiotics and ICU monitoring.
Inconsolable Crying after 22 month immunizations (pediarix, prevnar, hib).
This spontaneous report as received from a pharmacist refers to a adult male patient. The pharmacist reported that a patient who is currently 50 years old with renal failure (diagnosed prior to ever receiving PNEUMOVAX 23. The patient received two doses of PNEUMOVAX 23, each dose on separate date; first dose administered on 05-NOV-2014 and the second dose was administered on 10-JAN-2016. No adverse effects reported. No further information was provided. Additional information has been requested.
headache; nausea; vomiting; tiredness; chills; fever that went up tp 106.9 F; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number h2pe2, expiry date 19th May 2023) for prophylaxis.   On 18th March 2022 16:00, the patient received the 1st dose of Shingrix. In March 2022, less than a day after receiving Shingrix, the patient experienced nausea (serious criteria hospitalization), vomiting (serious criteria hospitalization), tiredness (serious criteria hospitalization), chills (serious criteria hospitalization) and fever (serious criteria hospitalization). On 20th March 2022, the patient experienced headache (serious criteria hospitalization). The patient was treated with antiemetics and antinauseants (Anti-Nausea (Nos)), hydrocortisone and intravenous fluid (nos) (Intravenous Fluids). On 20th March 2022, the outcome of the fever and headache were recovered/resolved. On an unknown date, the outcome of the nausea, vomiting, tiredness and chills were recovered/resolved.   It was unknown if the reporter considered the nausea, vomiting, tiredness, chills, fever and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient' wife. The patient received a dose of Shingrix last Friday around 4 pm and on Saturday morning the patient was feeling nauseous and started vomiting. The patient also felt tired, had chills, and experienced a fever that went up to 106.9 F.  The reporter stated that fever went up and down during the day and the patient called primary care doctor who recommended went to the emergency room. The reporter stated that they went to the emergency room on Saturday where the patient received IV fluids, a dose of hydrocortisone and anti-nausea medication. The patient went back from the emergency room on Sunday morning and was still experiencing a fever and headache which subsided that afternoon.  In March 2022, all symptoms were resolved. The reporter did not consent to follow-up.
Pt developed local redness and swelling to right thigh following immunization on 02/09/04.  Swelling and redness increased to include entire thigh.
Stinging pain as injection was given. Aching pain across both shoulders and up the back of the neck started about 6 hours after injection.  Pain in these areas persisted for about 2 weeks. Pain gradually disappeared from shoulders (first) and somewhat from the neck.  4 weeks after the injection there is still  some lingering tenderness in the back of the neck when turning head to the right or left.
Jaw soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw soreness) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (Jaw soreness). At the time of the report, PAIN IN JAW (Jaw soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not Reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) ,the reporter did not provide any causality assessment
Dizziness, injection site soreness, tiredness. All occurred around the same time. Around 4-6hrs after receiving the injection.
A physician reported that a 2 month old male received his firs doses of Prevnar, Hib (manufacturer unknown), DTaP (manufacturer unknown, IPV, and hepatitis B (manufacturer unknown) vaccines on 7/23/02. On 8/11/02, he developed pneumococcal meningitis. On 8/13/02, he was hospitalized. A CSF culture was positive for Streptococcal pneumoniae serotype 6B. No further information was available at the date of this report. Follow up information received on 22-Nov-2002 provided revised pt information and outcome. He recovered.
Initial report was received from a multiple health care professionals on 19 July 2011. A cluster of unidentified patients (total number of patients not reported) had received FLUZONE HIGH-DOSE (lot numbers, routes, sites and dates of administration were not reported) and an unspecified amount of time later, the patient's had reactions ranging from pain, stomach issues, fatigue and an overall ill feeling. No further information was available at the time of the report. The patient's outcomes were not reported. Documents held by sender: none.