chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tremendous high  blood pressure;  had to go to the ER.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 14:15 as dose 4 (booster), single (Lot number: fp4554) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: ff2587, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 07Oct2021, when the patient was 72-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: en5818, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 09Feb2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: e61283, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 19Jan2021, when the patient was 71-year-old, for COVID-19 Immunization. The following information was reported: HYPERTENSION (medically significant) with onset 08Jun2022 at 11:00, outcome "recovering", described as "Tremendous high  blood pressure;  had to go to the ER.". The event "tremendous high  blood pressure;  had to go to the er." required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Hypertension: (08Jun2022) blood pressure high, notes: Tremendous high blood pressure; SAaS-CoV-2 test: (01Jun2022) Negative, notes: COVID test type post vaccination nasal.Therapeutic measures were taken as a result of hypertension.
Injection 4/25/08 04/26/2008 8am woke up to complaint of sinus drainage, low grade temp. general feeling of weakness,and tired. 5/5/08 headaches started, comes and goes. Vomiting at times. Has past history of migraines.
PATIENT REPORTED MUSCLE PAIN EXTENDING PAST ELBOW, SWELLING OF LEFT ARM AND SAID HER LEFT SIDE (IMMUNIZATION SIDE) ALSO HURT.  NURSE AT DR WAS CALLED AND TOLD PATIENT TO TAKE TYLENOL AND IBUPROFEN FOR SORENESS/PAIN AND TO CALL IF PAIN WORSENED DURING THE DAY.
glaucoma; Eye pain both eyes; burning eyes; Nuclear catarct; possible sinus problems; migraine; This case was reported by a lawyer and described the occurrence of glaucoma in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2018, the patient received Shingrix (intramuscular) .5 mg. On an unknown date, an unknown time after receiving Shingrix, the patient experienced glaucoma (serious criteria GSK medically significant) and eye pain. On an unknown date, the outcome of the glaucoma and eye pain were unknown.   It was unknown if the reporter considered the glaucoma and eye pain to be related to Shingrix.  The initial information received on 10 December 2020 via medical records. As per records the female patient was non smoker.As per records on 22 May 2018 and on 19 October 2018, she had Shingrix 50mcg injection 0.5 ml into the muscle, repeat in 2 to 6 months. On 19 February 2019, she had follow-up of ocular pain, both eyes. She described to have pain as aching and burning and stated that was an aggravating problem. This eye pain began several months ago and is symptomatic almost constantly. She states that this seems to be gradually improving. On 29 January 2019, she stated eyes have been painful since having the shingles shot. She had Ocular pain, possible sinus problems, Inflammation from shingles shot, nuclear cataract and migraine
Ext. pain lasted 24 hrs. Extreme pain Rt. shoulder and arm elbow to shoulder. - Patient had stroke on 5-13 and fell on rt. shoulder causing soft tissue damage on 5-13- vaccine in same shoulder 5-16.
Dizziness, Headache, Myalgia, Arthralgia, NauseaVomiting, Malaise Narrative: Experienced injection site pain, joint pain, nausea dizziness day injection. Had a headache and more dizziness the following morning.
MMR II was administered intradermally rather than sub-cutaneous or intramuscular / process medication error ocurred at: administration; Was the operator trained? No MD administered due to no RN available; Sore arm; This spontaneous report was received from a physician and refers to an unspecified patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered intradermally rather than sub-cutaneous or intramuscular (Incorrect route of product administration) (strength, lot #, expiry date, dose, and indication were not provided). It was confirmed with HCP that no signs/symptoms of adverse reactions had been reported.   This case was considered as non-valid due to lack of patient identifiers.  Follow-up information has been received from the physician on 26-OCT-2023.  The patient was a 34-year-old female.  On 18-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (Lot number 3P993 is an invalid lot number for M-M-R II, expiration date reported as 30-JUN-2024) at a dose of 5 ml, administered intradermally instead of sub-cutaneous or intramuscular (Incorrect route of product administration) at her left arm (reported as L triceps). The vaccine was administered by a medical doctor (MD) as no registered nurse (RN) was available at private doctor's office/hospital, however, it was reported that the operator of vaccine (MD) was not trained (Product administered by wrong person). It was mentioned that the patient had no illness at time of vaccination.  On an unspecified date in October 2023, the patient experienced sore arm (Pain in extremity) (also reported that the patient had no adverse reaction [conflicting information]). It was not required a prescription drug treatment for the experience.  The outcome of the event of sore arm and its causal relationship with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), were not provided.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281687, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281636, 2018SA279979, 2018SA281632, 2018SA281692 (Same reporter). This case involves a two-months old male patient who was vaccinated with 0.5 mL dose of PENTACEL (lot number: C5507AA and expiry date: 05-Sep-2019) (dose in series and route was not reported) in the left thigh on 11-Sep-2018 which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Chills, stiffness, couldn't hardly walk, sore armpit, heart rate of 122, blood pressure 94/66 (low for her), headache, loss of appetite, weakness
Patient did not feel well the next day and stated her upper lip was swollen.  She did not have any difficulty swallowing or breathing, just had a swollen upper lip.
Right deltoid swelling, redness, heat at injection site of DTAP.  Swelling began 2 days after CID injection.  Went to ER.  Advised to apply heat (by ER) swelling gone today 04/22/2003.
*I AM UNSURE OF FLU INJECTION TYPE* all I know is I got the injected flu vaccine in my upper left arm  2:00pm - dizziness, general malaise, minor chest tightness, lack of appetite; decide to leave work for the day 2:30pm - arrive home, temp 98.6, begin increased water intake 3:00pm - take lactium (dose 234mg in case of anxiety attack, covid is still a thing and I'm afraid of getting it) & zyrtec (standard dose); temp 99.3, minor coughing (with phlegm), moderate body aches, previous symptoms continue (except chest tightness begins to decrease) 4:00pm - previous symptoms continue, added runny nose and stuffiness, hoarseness, nausea, temp sustained 99.3 6:00pm - coughing subsides, chest tightness subsides, all other symptoms continue 7:30pm - realize I haven't eaten since 7:30am, eat something (thanks ADHD) 8:00pm - all symptoms excluding body aches, runny/stuffy nose, and malaise have subsided; took two benadryl (total 50mg dose), fall asleep -- 8:00am, next morning - wake up, no symptoms besides soreness at injection sight and caffeine withdrawal headache
No BM from 10/11/08, vomiting, decreased diaper wetting, dehydration.  Currant jelly stool 10/14.  Intussusception -> hospitalized 10/14/08.  Required surgical intervention.  Pt. currently admitted to PICU at hospital. 12/1/08-records received for DOS 10/14-//-DC DX: Intussusception. Exploratory laparotomy, reduction of intussusception, small bowel resection incidental appendectomy. Presented with 1 day of emesis.  Following morning developed recurrent emesis and repeat ultrasound demonstrated recurrent intussusception and similarly reduced, however patient suffered a respiratory arrest during this procedure. Marked distention of abdomen and lethargy. Surgery demonstrated bowel eviscerated.
Patient complained of feeling faint 16 min after injection.   1st dose of vaccine was administered at 12:01PM.  Patients vitals at 12:19PM were 72/45.  Retaken at 12:20PM 88/58 pulse 86.  12:21PM patient was transported to Patient Assistance Area for further observation. She was ultimately discharged home.
10/19/2003 Lymph node swelling to left arm with swollen red streak from vaccine site to inner arm. Pain, swelling and itching to vaccine site.
Redness and swelling at injection site.  Swelling extended to the elbow from the shoulder
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for 2 patients. This is the second of 2 reports. An over 65 years old female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single in the arm, for immunisation. Medical history and concomitant medications were not reported. A couple weeks later the patient came into the store and said that experienced arm soreness around injection site on an unspecified date. Outcome was recovered. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017052137 same reporter/drug/event different patient.
On day 3 after  2nd vaccine on 4/16/2021 in left arm, the injection site became red, swollen, severe itching and covers 3 inches squared upper left arm.  This reaction came 3 days after the 2nd Moderna injection.  NO skin reaction 1st injection 28 days prior on 3/19/21
I menstruated for the first time in 6 years while on birth control. It started approximately 2 weeks after my second dose of Pfizer. It lasted 3 weeks..completely unexpected, heavy, and painful. If this vaccine can affect a regulated menstrual cycle, how will it effect the pre-pubescent and those yet not of child bearing potential (aka our young children)?
pt recvd vax 24AUG92 & 25AUG92 had diarrhea & flu like sx; seen by MD; pt recvd parepectolin as of 31AUG92 sx persists;
Throwing up; Dizzy; Weakness; Headache; This is a spontaneous report from a contactable Other-HCP (patient). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3248, on 05Feb2021 15:30 in left arm for COVID 19. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number EL1284) on 22Jan2021 13:30 in left arm. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced Throwing up, dizzy, weakness, headache on 06Feb2021 04:00. No treatment was received for all events. The outcome of the events was not resolved.
Symptoms occurred approximately 16 hours post injection. Symptoms included: injection site pain and swelling, body aches, muscle aches, cough, nausea, headache, loss of appetite, chills, body sweats, and fatigue.
Lymph node is about the size of half/baseball; It hurts like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced enlargement of lymph nodes and lymph node pain. On an unknown date, the outcome of the enlargement of lymph nodes and lymph node pain were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and lymph node pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. After receiving Shingles vaccine, lymph node under his/ her same arm in which injection was received was about size of half baseball. The patient stated it was hurt like crazy too. The patient did not see this side effect in the list of side effects. The patient asked what did this mean.
Information has been received from a consumer concerning her 16 year daughter who on an unreported date was vaccinated with varicella virus vaccine live (Oka/Merck). The patient's younger sisters (13 and 11), had also previously immunized. The 11 year old and 13 year old recently had a breakthrough of chickenpox, but the 16 year old was not affected with the recent exposure. The patient, at around 8 years of age, approximately 1998, had developed a mild case of chickenpox. This is one of several reports received from the same. Additional information has been requested.
Patient stated that 45 min. after receiving her first Maderna COVID-19 vaccination she experienced some drainage in the back of her throat and was unable to speak for an unspecified amount of time.
lips began burning; lips swelling; Lips pain; Painful mouth; burning, swelling, and hurting a lot. Its spreading to the rest of my mouth.; swelling, and hurting a lot. Its spreading to the rest of my mouth.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Apr2021 at 09:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease and gluten allergy. The patient previously took erythromycin (MANUFACTURER UNKNOWN) and metoclopramide (REGLAN) both were from unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) from 2005 and for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, Tuesday morning at 08:00 the patient  lips started burning, swelling, and hurting a lot. It was spreading to the rest of mouth and it was quite painful, although it was not anaphylaxis and definitely not life threatening. However, it continues to get slowly and steadily worse. The patient had severe celiacs disease, so the patient eats the same foods every day and never alter those meals, even down to the smallest ingredients. He was aware of everything that touches his skin. He was sorry to say but there really isn't anything else that could be causing this. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lips began burning, swelling, and hurting a lot mouth painful, mouth burning and mouth swelling were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a health professional refers to 5 unspecified patients of unknown demographics. Pertinent medical history and drug allergies were not reported. On unspecified dates, these patients received doses of improperly stored PROQUAD (Merck) (lot # K025760, expiry date: 08-JUN-2016). Concomitant medications were not provided. No adverse effect was reported. Outcome of the event, incorrect product storage was unknown. Causality assessment was not provided. This is one of two reports received from the same source. Additional information has been requested.
Pt was admitted on 4/16/21 to hospital  from the ED for shortness of breath,  after receiving  second dose of vaccine on 4/1/21
12 year old patient received 1 dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The reporter stated that, the patient had no prior immunization history and needed catch up vaccines. The reporter was unaware that Twinrix was for 18 plus years old and the patient who was 12 years of age, received 1 dose of Twinrix, which led to inappropriate age at vaccine administration. The patient was doing fine and denied side effects. The reporter asked if this immunization was still able to be counted toward her vaccine history or not. The reporter was following the CDC (Center for Disease Control) catch up plan. The reporter consented to follow up. No further details provided in email.
Tounge started itching and raw feeling like something scalded it.  Same feeling when I have something that has touched something I am allergic too.
Within 18 hours of the vaccine, I experienced: arm pain, fever, sore joints, skin hurt to the touch, UTI sensation when urinating Within 2 days, I experienced: sore joints, skin hurt to the touch, UTI sensation when urinating, sore throat Within 3 days, I experienced: skin hurt to the touch, UTI sensation when urinating, sore throat, sores inside of mouth Within 4 days, I experience nausea and still had sores in my mouth
About 3 hours after the shot, my face and upper body broke out in hives.  They lasted for about 90 minutes.  I used some hydrocortisone cream and took an allergy pill which probably helped.
4 month old received DTaP, IPV, PCV7, HIB; immediately after 4th shot, he became bright red on limbs, hands, feet minor on trunk; face very red. Rash resolved in about 5 minutes or less and he was fine. 8 hours later, he developed T 100-101, some loose stools (4-5x), vomited twice, flushed red again with fever, decreased PO. Seen here the next day with T 100.7 and very irritable. Admitted for 24 hours but looked well in hospital. WBC 19.4, diff. normal; CRP 3.6. Discharged yesterday; still with T 100.3, smiling now. Still low PO but ok.
3:45PM was given vaccinations. 4:20PM irritability, crying and swollen, redness to face, ears. 4:50PM went to ER whole body red. Epi x2, liquid Prednisone ER physician could not find any other cause for reaction.
Patient was anxious to receive vaccine mother was sitting at her side. PT stayed still and received vaccine well after placing bandaid PT feel backwards onto gurney in treatment room. Mother immediately told the PT to stop acting like that and to stand up, PT did get up with help from mother then swung to floor mother told her to get up again and started walking out of treatment room. I asked them to sit in the chair and wait to leave because it was difficult to tell if she was fainting or acting. The mother said she does this when she gets vaccines and was not concerned. The PT fell back in chair and appeared limp she did this repeatedly 5 times I asked Dr. to come over to check PT because she was nearby LVN also came to check on PT we gave her water and her appearance looked better and they proceeded to leave. Mother stated she has dose this sometimes when she gets Immunizations.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored vaccinated with VARIVAX subcutaneosly, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA009447: US-009507513-1808USA003515:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.