chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen arm; lump on arm; hurt arm; high blood pressure; dizziness; weakness; throat swelling; allergic reaction; difficulty swallowing; sore throat; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox and thrombophlebitis leg (placed on azithromycin. Switched to Bactrim due to reaction to azithromycin. Bactrim caused patient to break out in hives.). Previously administered products included Zostavax (received vaccine in 2008), azithromycin with an associated reaction of hypersensitivity and Bactrim with an associated reaction of urticaria. Concurrent medical conditions included egg allergy (based shot in 1960s).   On 24th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling, injection site lump, pain in arm, blood pressure high, dizziness, weakness, throat swelling, allergic reaction, swallowing difficult and sore throat. The patient was treated with medication unknown (Blood Pressure Medication). On 1st October 2019, the outcome of the blood pressure high was resolved with sequelae. On an unknown date, the outcome of the injection site swelling, injection site lump, dizziness and sore throat were recovering/resolving and the outcome of the pain in arm, weakness, throat swelling and allergic reaction were unknown and the outcome of the swallowing difficult was resolved with sequelae.   It was unknown if the reporter considered the injection site swelling, injection site lump, pain in arm, blood pressure high, dizziness, weakness, throat swelling, allergic reaction, swallowing difficult and sore throat to be related to Shingrix.  Additional details were provided as follows: The patient experienced swelling and a lump around the injection site on her arm. The area was 3 inches in diameter. The arm was hurting. The patient also experienced very high blood pressure. Blood pressure stated as 192/107.   The patient's normal blood pressure was approximately 120/70. The patient also experienced dizziness, weakness, throat swelling, and difficulty swallowing.  The patient felt as though this was a severe allergic reaction to Shingrix. The patient did not consent to follow up.      Lab Comments: on an unknown date blood pressure measurement recorded.
Pt received DTaP/PCV vaccines in AM of 7/29/06. Developed significant fever ~12 hrs later just before midnight. Mom awoke to find child having GTCS; drove patient to ED. In ED, given Ativan x3 before status epilepticus resolved. Admitted. Child had subsequent fevers controlled w/ antipyretics; no further seizures. EEG deemed unneccessary by C/S Neurologist. D/C'd on HD #2. Told DTaP contraindicated in future.
She was feeling loopy; dizzy; had an earache; This is a spontaneous report received from a contactable consumer from a sales representative. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "She was feeling loopy"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; EAR PAIN (non-serious), outcome "unknown", described as "had an earache".  Additional information: She was feeling loopy, dizzy, and had an earache after receiving the first dose of the Covid. 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.
developed supra ventricular tachycardia 2 months after my booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, I also had a reaction to the first vaccine which did disappear after 3 days), for Covid-19 immunization, reaction(s): "I also had a reaction to the first vaccine".  The following information was reported: SUPRAVENTRICULAR TACHYCARDIA (medically significant), 2 months after the suspect product(s) administration, outcome "unknown", described as "developed supra ventricular tachycardia 2 months after my booster shot". Clinical information:I've developed supra ventricular tachycardia 2 months after my booster shot I am 66 years old could that have been from the vaccine I know super ventricular tachycardia has occurred directly after the vaccine could it have had occurred later on I also had a reaction to the first vaccine which did disappear after 3 days  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recvd 1st dose of vax w/o adverse exp on 7SEP90; 2nd dose of vax recvd 09OCT90 & approx 24 hrs later, pt exp nausea; addtl sx included tiredness & lack of appetite; nausea persisted x approx 2 wks; Anti-HBs titer was 1.4;
Oct 13, 2021: 22 year old female patient received her second COVID 19 vaccine. Patient stated before the vaccine was administered that she had no previous issue with the first dose.  Patient was told to report to the patient observation area for 15 minutes.  Patient however had reported to the vaccination waiting area with no one observing.  Admin clerk reported the reaction at 14:33 and called for assistance. patient reported feeling dizzy and lethargic and pale and diaphoretic.  Patient began to lose consciousness; Epinephrine was administered via left thigh.  patient vitals were then taken with BP 95/67 sp02 99 HR 79.   Patient then requested to be laid down on the ground for comfort where an ice pack was administered to posterior neck. Patient  stated having a vasovagal reaction to the previous flu shot. Vital signs were Within Normal Limits. Patient taken to the Emergency Room based off hospital protocol.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). Other case identifier: NVSC2020US100435). A 59-year-old female patient received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 59, on Mar 23, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced asthenia (debility with ambulation), felt  abnormal (brain fog) and pain, onset 2021, with outcome of recovered (2021). Follow-up attempts  completed. No further information expected.
patient was given moderna vaccine instead of Pfizer vaccine, no adverse effect were reported up to report date
Patient developed nausea/vomits, loss of taste and abdominal pain 6 days after dose 2 of Pfizer vaccine. Admitted after having had loss of consciousness  and found to have acute liver injury on laboratory and peripheral blood lab values consistent with DIC and thrombocytopenia. Infectious workup negative, imaging studies were negative for ischemic etiologies. Patient had a new thrombus on imaging in the false lumen of a previously  repaired aortic dissection. PF4 antibody assay was positive concerning for VITT. Treated with high dose steroids with stabilization of thrombocytopenia, improvement in liver function studies and improvement in clinical symptoms. Patient currently still hospitalized.
This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 73-year-old male patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced difficulty thinking (serious criteria GSK medically significant), racing thoughts and thought process disorder. On an unknown date, the outcome of the difficulty thinking, racing thoughts and thought process disorder were unknown. It was unknown if the reporter considered the difficulty thinking, racing thoughts and thought process disorder to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that after receiving SHINGRIX, the patient experienced that his thoughts were racing, could not think straight, and could not get thoughts together. The HCP was not sure when the side effects occurred or if they subsided. No additional information provided.
Extreme fatigue, Extreme muscle and joint pains, muscle cramps, no appetite, headache
could not move to put on his shoes after dose 3/could not bend over after dose 3; major side effects after dose 3; extreme fatigue after dose 3; stiffness hip joint after dose 3/stiffness front of the leg near knee after dose 3; stiffness shoulder after dose 3/stiffness deltoids after dose 3/stiffness upper back after dose 3; severe stiffness after dose 3 and ongoing; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (severe stiffness after dose 3 and ongoing), MOBILITY DECREASED (could not move to put on his shoes after dose 3/could not bend over after dose 3), JOINT STIFFNESS (stiffness hip joint after dose 3/stiffness front of the leg near knee after dose 3), MUSCULOSKELETAL STIFFNESS (stiffness shoulder after dose 3/stiffness deltoids after dose 3/stiffness upper back after dose 3) and VACCINATION COMPLICATION (major side effects after dose 3) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Coronary artery disease. On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (severe stiffness after dose 3 and ongoing), JOINT STIFFNESS (stiffness hip joint after dose 3/stiffness front of the leg near knee after dose 3), MUSCULOSKELETAL STIFFNESS (stiffness shoulder after dose 3/stiffness deltoids after dose 3/stiffness upper back after dose 3) and FATIGUE (extreme fatigue after dose 3). On an unknown date, the patient experienced MOBILITY DECREASED (could not move to put on his shoes after dose 3/could not bend over after dose 3) and VACCINATION COMPLICATION (major side effects after dose 3). At the time of the report, MUSCULOSKELETAL STIFFNESS (severe stiffness after dose 3 and ongoing), JOINT STIFFNESS (stiffness hip joint after dose 3/stiffness front of the leg near knee after dose 3) and MUSCULOSKELETAL STIFFNESS (stiffness shoulder after dose 3/stiffness deltoids after dose 3/stiffness upper back after dose 3) had not resolved and MOBILITY DECREASED (could not move to put on his shoes after dose 3/could not bend over after dose 3), VACCINATION COMPLICATION (major side effects after dose 3) and FATIGUE (extreme fatigue after dose 3) outcome was unknown. The patient administered third dose and not booster dose because he was travelling and was advised by the doctor to get it. The patient reported that did a full battery of lab work, all tests came back normal.The concomitant medication included medication for blood pressure and heart medication. No treatment medication was reported.   This case was linked to MOD-2021-363353, MOD-2021-363189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Significant Follow Up added: Events added, Reporter added, Patient details added and concomitant medication details added.
Severely Bloodshot Eyes/blurry Vision for two days. I never have had this problem.  Sensitivity to smells causing migraines. Couldn?t even smell brownies baking in an oven without a severe headache and nausea. Side effect still happening more than a week after dose received   Continued back pain for a week
Pt recvd 1st vax of Hep B vax 11APR89 & devel swelling & soreness of axillary nodes,which resolved p/ 1-2 days.On 07JUN89 pt recvd 2nd vax & devel swelling & soreness of axillary nodes w/ generalized weakness.Sx resolved p/ 2-3 days.
sick stomach not feeling well all over;pain on rt side into neck;redness & swelling below site;
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298573, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298512, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a patient of an unknown demographics who received 5 mL dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route in arm NOS on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HD. It was actual medication error due to Overdose and incorrect product storage. It was reported that patients were injected with previously frozen 5 mL FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. It was unknown whether patient experienced any adverse reaction after vaccination. 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.
7.2.21: patient seen in ED and diagnosed with COVID-19.  7.5.21: Patient returned to the ED due to symptoms worsening. Symptoms included: myalgias, weakness and cough. Hospitalization due to COVID-19 infection. Diagnosed with community acquired pneumonia and hypoxia. Remdesivir started. 7/8: Completed a 4 day course of remdesivir and was discharged home.
100.8 fever, chills,  extreme fatigue, severe headache, muscle pain, loss of appetite, injection site pain
rapid test positive; rapid test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 18:00 as dose 1, single (Lot number: EN6208), in left arm and on 06Apr2021 at 18:00 as dose 2, single (Lot number: EW015) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 at 18:00 as dose 3 (booster), single (Lot number: 058F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Benign tremors" (unspecified if ongoing), notes: Benign tremors. Concomitant medication(s) included: PRIMIDONE; DICLOFENAC; ADVAIR; CBD OIL. Past drug history included: Tylenol, reaction(s): "Known allergies: Tylenol", notes: known allergies Tylenol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Oct2022, outcome "not recovered" and all described as "rapid test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received the vaccine. Other medication received in 2 weeks included primadone, diclofenac, advair, CBD oil. Patient had rapid test positive 09Oct2022 and started treatment with Paxlovid 09Oct2022, stopped taking all meds except Advair during 5 day course.  Follow-up attempts are completed. No further information is expected.
Mother called HD at 3:30 PM reported child was ok, took a nap, woke up at 1:30- 2 AM and she noticed some red spots on face. Later she noticed hyper itching, when she called she said he was broke out from head to toe and complained of having a little belly ache. Says she could not get a hold of doctor and left message. Nurse told mother to give Benadryl according to package directions and q6h and to continue to try and contact doctor. talk to mother next day says she took child to MD by then his rash was gone since he took Benadryl. Also had redness at site of MMR. Mom says after second dose of Benadryl rash was completely gone. MD said if rash went away with Benadryl that it was most likely the vaccine the vaccine.
Large swelling size of baseball at injection site, hard raised, itchy, and painful to the touch. I did not have this at all after first shot; just the second.
2 days after administration of TDAP vaccine in right deltoid, patient developed severe pain and bruising at injection site with report of chills, nausea.  4 days later patient noticed swelling and bruising of her right wrist
Information has been received from a lawyer regarding a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 24-JUN-2011 the patient was vaccinated with ZOSTAVAX, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-FEB-2013 the patient was treated at an Urgent Care clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was referred by the urgent care facility to a physician for subsequent treatment of her severe shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
A serious spontaneous report of tightness in airway, difficulty in swallowing and non-serious events of migraine headache, rash has been received from a registered nurse/health professional concerning a 30-year-old female, subsequent to H1N1, Intranasal vaccine. Neither medical history nor concomitant medications was reported for this patient. On 10-Nov-2009, the patient received H1N1, Intranasal vaccine for an unknown indication. On 11-Nov-2009, the patient became lightheaded, developed rash and migraine headache. On 12-Nov-2009, the patient developed tightness in her airway and had difficulty in swallowing. She was prescribed prednisone 40mg once daily for two days and 20mg once daily for three days. The outcome of the event was unknown.
Dizziness; Dry eyes; Arm pain and stiff arm on side of injection (left); Pain near right collarbone; Fever 99.6; Arm pain and stiff arm on side of injection (left); Facial flushing/ tingling; Facial flushing/ tingling; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 16Jul2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's, mitral valve prolapse (MVP), melanoma 20 years ago from an unknown date in 2001 and allergy to sulfas and decongestants. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included vitamin B12 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN), calcium/ magnesium/ zinc (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), selenium (MANUFACTURER UNKNOWN), iodine (MANUFACTURER UNKNOWN) and curcuma longa rhizome (TUMERIC); all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 25Jun2021 at 17:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient previously received doxycycline (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 17Jul2021 at 04:30, the patient experienced fever 99.6 (unspecified units), arm pain and stiff arm on side of injection (left), pain near right collarbone, facial flushing/ tingling, dry eyes, nausea and dizziness. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events fever 99.6 (unspecified units), arm pain and stiff arm on side of injection (left), pain near right collarbone, facial flushing/ tingling, dry eyes, nausea and dizziness were unknown.
Pt came in to receive her annual flu shot on 10/13/17 around 7 pm. I had gone over her vaccine consent and administration record form and had asked her if she had an issues with vaccines in the past. She stated she was scared of needles and I noticed she had her other arm clenched indicating this as well, so I had her 9 year old daughter try to distract her; I myself also tried to talk her up to distract her as well. After administering the vaccine, the Pt responded that it was quick and she didn't even feel it. Shortly after, she started feeling dizzy so I told her to sit down. I asked her if she wanted water and she said yes so I grabed a cup for her and checked up on her once again. She said she was gonna sit for a little longer. In the meantime i went to verify a few more prescriptions and walked over one more time. After heading back to the RPh station to verify more prescriptions, at this point it time I heard a sound and the Pt had then fainted. Another Pt was a first responder, I ran over to check her pulse, pt was still unconcious at the time. Nurse practioner within our store came over to assist in the incident. Pt woke up from the fall soon after (aprox. 2 min). Pt was alert and orient and daughter was a little frazzled and scared. 911 was called, they showed up after 5 min to evaluate the pt after the fall.
Pneumoperitoneum of unknown etiology - Procedures performed:  Exploratory laparotomy, abdominal lavage, appendectomy. Recovery in hospital and discharge home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Student was supposed to have her second dose of Pfizer but was given mistakenly J&J at 0.3ml dose.
Patient awoke the day after the immunization and had developed a golf ball sized spot on her arm,  the spot was red, slightly raised, with some heat coming off of it, and "a little" sore per the patient.