chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2013US017433 is an initial spontaneous report from the nurse received on 14 AUG 2013. This report refers to a 16-year-old male patient. On 14 AUG 2013, the patient was accidentally vaccinated with Men A lyophilized conjugate of MENVEO (batch number: A12092), mixed with a sterile diluent instead of MenCYW-135 liquid component. No adverse reaction reported following this medication error. No other information was available.
Patient was seen in the ER for stroke symptoms: No. Chief complaint: Diaphoretic, lightheaded, weakness. History of present illness: Patient with a history of atrial fibrillation status post ablation therapy in October 2014 is an employee at this hospital undergoing his routine hepatitis B vaccine. Patient received initial dose hepatitis B vaccine July 2015 and developed similar symptoms requiring rehydration therapy. Today patient receiving second dose of the above with significant symptoms as outlined above. Patient apparently quite diaphoretic appears minimally flushed and reports weakness and lightheaded feeling making it difficult to walk. Patient denies shortness of breath or throat tightness. No new medications. No new toiletries. Vital signs please see nurse notes. General exam patient appears exhausted but able to answer all questions appropriately. Cardiac exam: Regular rate and rhythm. Pulmonary exam clear to auscultation bilaterally. Abdominal exam positive bowel sounds, nontender nondistended no organomegaly no masses or bruits no guarding noted. Extremity exam 1+ pedal edema bilaterally no palpable cords negative Homans sign. HEENT pupils equal round reactive to light. Eyes injected bilaterally. Nose without discharge blood free fluid. Throat mucous membranes moist no erythema no exudates. Ears without discharge or erythema no free fluid seen. Neuro exam: Motor 5 out of 5 bilaterally. Sensory exam intact upper and lower extremity bilaterally. Laboratory findings: EKG findings: Sinus rhythm with a rate of 66. Patient does have criteria for left ventricular hypertrophy. No ST-T changes seen. ED course: Shortly after arrival patient given 1 L normal saline and BENADRYL 50 mg IV. Assessment and plan: Drug reaction to hepatitis B vaccine. Each reaction has been more serious than the previous. Strong consideration should be given to whether benefits outweigh risk for completing hepatitis B vaccination series.
This spontaneous report as received from an emergency medical technician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concurrent conditions was provided. The reporter stated that on an unknown date, the patient might have been vaccinated with improperly stored doses of PNEUMOVAX23, lot number M029681, expiration date: 22-JAN-2018 or lot number M029680, expiration date: 17-JAN-2018, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion in the range of 9 degrees Celsius to 25 degrees Celsius for 47 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter (linked with MARRS# 1703USA008698 and 1703USA009933). Additional information has been requested.; Sender's Comments: US-009507513-1703USA009933  US-009507513-1703USA008698:
This spontaneous report as received from a pharmacy intern refers to a patient of unknown age and gender. On 14-AUG-2014 the patient was inadvertently administered ZOSTAVAX (lot # J004599, expiration date 18-JUL-2014, dose was unknown) subcutaneous which expired on 18-JUL-2014. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Suspected vaccination failure; Took the shot then got the Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: The reporter had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Varicella vaccination given by intramuscular route rather than subcutaneous route. Patient has experienced no adverse effect from the immunization.
felt bad; flu like symptoms; fever.; This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: felt bad), influenza-like symptoms (Verbatim: flu like symptoms) and fever (Verbatim: fever.). The outcome of the feeling bad, influenza-like symptoms and fever were resolved (duration 24 hrs).   It was unknown if the reporter considered the feeling bad, influenza-like symptoms and fever to be related to Shingrix.     It was unknown if the company considered the feeling bad, influenza-like symptoms and fever to be related to Shingrix.   Additional Information: GSK Receipt date:07-APR-2023. The reporter is the patient. The patient received Shingrix and felt bad with flu like symptoms and fever. Symptoms resolved in 24 hours. The reporter did not agree to follow up from GlaxoSmithKline.
Pt. received Tenivac on 4/21/21 that expired on 4/19/21.  Parent was contacted by voicemail and letter.  Awaiting response to schedule a repeat dose.  No known adverse events.
2 weeks after the vaccine developed tongue and lip swelling; 2 weeks after the vaccine developed tongue and lip swelling; This is a spontaneous report from a contactable pharmacist. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included dental work. The patient's concomitant medications were not reported.  The patient received first dose of vaccine and 2 weeks after the vaccine developed tongue and lip swelling. Patient was not sure if it was from the vaccine or from dental work that she had done. The reporter was calling to see if there was any information on this. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented with cough, congestion, SOB, and headaches. Patient was fully vaccinated with J&J and resulted positive.
Patient called for encounter: She received Pfizer COVID-19 Vaccine 07JAN2021. 08JAN2021 developed flushing on face, lower extremities and hives on left leg. Hives progressed to both legs and arms. She then developed swelling on the left side of the roof of her mouth. She started taking benadryl every 4-5 hours for 7 days. She did not use the EpiPen. Simultaneously patient developed vasculitis flare - pain involving ankles and lower legs. No hx of allergy to polyethylene glycol. Prior to vaccine - no changes in exposure other than eye surgery the day before vaccine which utilized the same medications that have been used for prior eye surgeries
Participant felt atrial fibrillation and confirmed with smart watch. Participant will be having some tests run by cardiologist at the end of the week as that is the soonest he could get in. Cardiologist started participant on a blood thinner. That data is not available at time of reporting.
Approximately 5 minutes after receiving vaccine I noted an intense flushing and burning sensation from my waist up followed by tachycardia with heart rate in 150s elevated BP 150/100. These symptoms subsided after approximately 10 minutes but were then followed by a ?cloudy? feeling in my head as well as tingling in bilateral hands that lasted the rest of the day but had resolved by the next morning. The next morning I felt very well until 2 pm when I had a short period (approximately 2 minutes) of elevated heart rate (120s) that then resolved.
Approximately 2 hours after my booster (3rd vaccine) shot, my lips started to swell and I took Benadryl, 20Mg of Prednisone (Steroid) and Ibuprofen and the swelling went away about 45 minutes after.
Dizzy, headache, nausea resolved after 20 mins. Temp 99.5.
Pt received pneumococcal conjugate on 4/7/11. Now has swollen area over injection site as well as sense of itchy hives in a circular pattern at small of back. Advised liquid BENADRYL local ice & urgent care if worsens.
Arm Swelling; Mild Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm Swelling) and FATIGUE (Mild Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal, Fruit allergy, Pollen allergy, Hypertension (1995) and Cholesterol high (1995). Concomitant products included SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension.    On 09-Feb-2021 at 8:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Arm Swelling) and FATIGUE (Mild Fatigue). At the time of the report, VACCINATION SITE SWELLING (Arm Swelling) and FATIGUE (Mild Fatigue) had resolved.            The patient recovered from the events of arm swelling and mild fatigue within 72 hours of vaccination.    This case was linked to MOD-2021-010929 (Patient Link).
I felt a couple seconds of a burning sensation during my booster injection.  About four hours later, the injection site started to turn red and itch.  By next morning apper arm was red with a hard lump about 4" in diameter.  Area feels hot and is painful to the touch, like my skin was burned.   I am also running a low fever (under 102).  Today is the third day after vaccination and arm is not showing any improvement.  Still feels hot, skin is red, swollen and painful to the touch, I had no adverse reaction to my first two Moderna vaccines.
Overwhelming weakness; Blood pressure was elevated to 160/100 bpm; Brain fog; Thought was going to pass out, thought she was going to die; Pre-syncope episode; Systolic blood pressure of 180; Rigors in her chest; Neuro effects; A spontaneous report was received from a nurse who was also a 48-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced brain fog, pre-syncope episode, systolic blood pressure of 180, rigors in her chest, neuro effects, blood pressure was elevated to 160/100 bpm, overwhelming weakness and thought was going to pass out, thought she was going to die.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 31 Dec 2021, approximately 9 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  The patient had some brain fog off and on after receiving vaccine. About the 8th day on 08 Jan 2021, had a pre-syncope episode with systolic blood pressure of 180, thought patient was going to pass out and had rigors in patient's chest. Patient's husband called emergency medical service and went to the hospital where patient works, patient was evaluated in emergency room. The next day, patient rested at home. The following day, on 10 Jan 2021, patient went to work but couldn't think due to brain fog and neuro effects. After work, went back down to the emergency. Patient was admitted to the hospital and kept overnight. Consulted the neurologist. Neurologist stated it sounded like it was side effects from the immune response to the vaccine. Discharged the 11 Jan 2021 with no treatment besides follow-up with primary care doctor. Patient followed up with patient's primary care (cannot remember what date). The patient reported experiencing more pre-syncope episodes at home and at work. Patient's blood pressure was elevated to 160/100 bpm. Most recently had a syncope episode on 21 Jan 2021 where patient reported overwhelming weakness and had to sit down because patient "thought patient was going to die". After, made an appointment with the cardiologist. Had more test done. After taking medications patient felt a little bit better but had in head where doesn't feel right, feels little pings in head. Patient stated that patient missed forty hours of work because didn't feel so could work.  Relevant laboratory tests included computed tomography scan of chest and brain, an Magnetic resonance imaging of the brain was performed results unspecified. Did bloodwork which showed her vitamin D level was low.  Treatment for the event included fluids unspecified, vitamin D supplement for vitamin d deficiency, Toprol 25mg once a day to stop the pre-syncope episode and lisinopril 5mg once a day for blood pressure  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Pt reported developing significant cramping pain/aches in her lower left leg (and some in right leg but not as severe) starting 48 hours after receiving the injection. It lasted from approximately 3PM-5AM (the next morning). Pt consulted with her PCP and they eliminated other possible causes of lower leg pain (DVT, etc). Pt said she has past h/o leg cramps, but this pain was much worse than normal. Pt said that her pain has since subsided and she is not concerned about any lingering issues.
Lightheaded, chest tightness, throat hoarse and tight face flushed. See attached ER note.
12/21/19 Patient said 2nd dose made her ill. She didn't have any issues with the first shot.  She got the shot on a Thursday and went to the ER that night. She said she was vomiting, feverish, and trembling. She said she couldn't move her arm and couldn't get out of bed. ER had put a cold pack on the arm she got a shot in  and they told her that their wasn't much they could do for her that the shot will make some people feel that way. I told her also about the side effects the day of the shot and that she needs to take Tylenol or Motrin every 4-6 hours for the inflammation and that she would feel better in a couple of days and ice the arm again  12/26/19 called to check on patient and she said she was slowly getting better. she said the muscle before the elbow is what hurts the most. she said she can lift her arm a little this morning but pain still shoots up and down her arm. she said she had to use a walker to get around Friday and Saturday.  she told me she took some medication after her shot to make her feel better on an empty stomach. she said that may be why she vomited.  she said she lost mobility  at home after the shot meaning she got dizzy and passed out when she got up to go to the bathroom. i told her to keep massaging her arm and using the ice packs.  01/01/2020 Follow up phone call with patient. She says she is able to use the arm,  but it is still painful. She is rotating ice and heat as directed (heat helps more).
Rash to back, stomach, and neck BENADRYL 25mL and TYLENOL 3.6mL given. Patient observed for 15 minutes.
There were NO REPORTED ADVERSE EVENT. Vaccine was administered at 1 day past the UPDATED EXPIRY of 08/23/21 though still within vaccine PACKAGE EXPIRY date of 08/31/21. The Only filing as a VACCINE ADMINISTRATION ERROR report.
Patient inadvertently received a 5-11 year old dose instead of his age appropriate dose.  Parent notify of administration error.
Patient called in to report May 1 that she broke out into hives, They are itch and burn. Patient has been to the dr. Patient stated that medicine is not helping her and the Dr. can not explain to her way she is breaking out this way, Patient states that she was not changed anything in eating, cleaning products, or bath products.
COVID-19 confirmed by positive COVID-19 test; thought she had pneumonia or bronchitis; Caller states she would have reported within 24 hours, but she just did not feel well enough.; thought she had pneumonia or bronchitis; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736), via an unspecified route in the right arm on 29Apr2021 at 08:00 (at the age of 44-years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: GN6204), via an unspecified route in the left arm on 08Apr2021 at 08:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021, the patient experienced and went to urgent care, she thought she had pneumonia or bronchitis, they did a rapid test and the rapid test came back positive and that day, she went to the store drive-thru to get a molecular test and on 10Jul2021, the molecular test came back positive but they didn't specify if it was the variant or not. Patient stated that she would have reported within 24 hours, but she just did not feel well enough and she is perfectly healthy, she's not on any medications. The patient visited to physician office and not went to emergency room. The outcome of the events was unknown.
This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. The consumer reported similar events for two patients. This is a second of two reports. A male patient of an unspecified age and ethnicity received on an unspecified date, TRUMENBA at single dose. Relevant medical history and concomitant medications were unknown. The patient experienced swelling, extreme pain and limited arm movement, all on an unspecified date with unknown outcome. The events required a stay home from school on the next day. Follow-up (08JUL2016): Follow-up attempts are completed. No further information is expected.
abdominal pain, multiple episodes of emesis, near syncopal episode about 8-12 hours after vaccination.  Due to near syncopal episode parents called EMS and was brought to the ER. Seen at  ER and transferred to Medical Center pediatric floor for 24hr obs.
I went home I was working on the computer and I felt fine. The next day I had chills, I was so cold, I  was under 3 blankets freezing my butt off. I took my temperature and it was normal. I started having heart palpitations in May. They put me on Midodrine. The heart palpitations low Blood Pressure, which I did not have prior to my vaccine. I could feel my heart beating rapidly when I was at rest.
Severe, debilitating anxiety. An anxiety attack daily from day 1-4 following vaccination
Patient noticed some pain in right shoulder (location of vaccine administration) the evening the day the vaccine was administered. He presented with more severe symptoms the next day. The symptoms included severe pain in the right shoulder as well as mild muscular pain throughout his body.
Arm is swollen bad, super swollen; Really red huge whelps about 3-4 inches; Itchy; Really bad headache; Body ache; Chills; Fever; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches), PRURITUS (Itchy) and HEADACHE (Really bad headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, DICLOFENAC and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 06-Mar-2021, the patient experienced HEADACHE (Really bad headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Mar-2021, HEADACHE (Really bad headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore), PERIPHERAL SWELLING (Arm is swollen bad, super swollen), URTICARIA PAPULAR (Really red huge whelps about 3-4 inches) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Motrin, Anacin, Ice pack.
First dose of Pfizer - 03/06/2021 at a Coliseum. Second dose of Pfizer - 04/03/2021 at pharmacy.  Presented to the ED at on 5/9/21 with fever to 39.6C, HR 120s, throat pain, myalgias, headache, improved with IVF, tylenol, ibuprofen. Re-presented to ED on 5/13/21 with fever 39.5C, HR 120s, chest pain, dyspnea on exertion limiting her ability to walk >2 blocks as well as the remainer of her prior symptoms, with troponin 1.95 and TTE with new pericardial effusion. No sick contacts. Admitted at hospital 5/13 - 5/16 for myopericarditis, improved with colchicine, ibuprofen, and fluids. Sx persistent at post-discharge clinic visit.
Upon receiving this vaccine, I had no immediate reactions. However, upon arriving home around 4:30pm, I realized that I had the cold chills. Around 6pm, I had a very intense headache. It was also at this time that I began to feel very tried and fatigue.  By 10pm my entire body was tense, and hurting! Teeth were chattering because I was so cold and even the slightest LIGHT hurt my head.  I woke up around 2am COVERED in sweat with a fever. Fever was 101.2 (my normal temp is 97.8).  I had to change clothes TWICE due to soaking them through. I was not cold at this time. Just HOT.  At 7:30am, I awoke with the same headache as the night before, accompanied by a fever blister. Chills started again around 11:30am.  It is currently 12:56pm & I am suffering from the headache, chills & lots of stiffness throughout my back and neck still. I will continue to monitor my symptoms & report anything new.