chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu that has turned into pneumonia; patient had flu after taking flu shot; Initial information was received on 21-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional via social media.  This case involves a male patient (age unspecified) who experienced flu that had turned into pneumonia (influenza), (pneumonia), after he received INFLUENZA VACCINE.  The patient's past vaccination included influenza vaccine as prophylactic vaccination.  The patient's medical history, past medical treatments, concomitant therapy, and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed flu that had turned into pneumonia (influenza), (pneumonia) (Unknown latency) following the administration of INFLUENZA VACCINE. Event pneumonia was assessed as medically significant.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available on lot number for this case.; Sender's Comments: This case involves a male patient (age unspecified) who experienced influenza and pneumonia after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
SNF called to report patient developed a cough, fever 100.8, and malaise today. This despite ceftriaxone and vancomyicn antibiotic therapy for his prostate abscess. He needs timely eval to include blood tests, nasal PCR, CXR, etc. Consider drug fever if no source found.
Headache; nausea; mild body aches; hot flashes; This is a spontaneous report from a contactable nurse (patient).  A 39-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular at right arm on 21Dec2020 17:45 at single dose for COVID-19 immunization at a hospital. The patient's medical history included migraines, bipolar II, anxiety, attention deficit hyperactivity disorder (ADHD) and insomnia. No allergies to medications, food, or other products. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), diphenhydramine hydrochloride (BENADRYL), lamotrigine (LAMICTAL), nortriptyline, alprazolam (XANAX) and multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination, and since the vaccination, the patient been had not tested for COVID-19. It was reported that on 22Dec2020 17:45, the patient experienced headache, nausea, mild body aches, and hot flashes. Treatment for the reported events included that the patient took ondansetron (ZOFRAN) and acetaminophen (Tylenol) that she had at home. She took them on her own. No doctor needed. The outcome of the events was recovered in Dec2020.
Sick for three days; Chest pain; Night sweeting; Not being able to sleep; Dizziness while standing or resting; Voice changes; Muscle weakness and fatigue; muscle cramps; Felling tired all the time /felling "beaten down"; Terrific headaches and chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep) and DIZZINESS POSTURAL (Dizziness while standing or resting) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Pulmonary hypertension.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep), DIZZINESS POSTURAL (Dizziness while standing or resting), DYSPHONIA (Voice changes), MUSCULAR WEAKNESS (Muscle weakness and fatigue), MUSCLE SPASMS (muscle cramps), FATIGUE (Felling tired all the time /felling "beaten down") and HEADACHE (Terrific headaches and chest pain). At the time of the report, ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep), DIZZINESS POSTURAL (Dizziness while standing or resting), DYSPHONIA (Voice changes), MUSCULAR WEAKNESS (Muscle weakness and fatigue), MUSCLE SPASMS (muscle cramps), FATIGUE (Felling tired all the time /felling "beaten down") and HEADACHE (Terrific headaches and chest pain) outcome was unknown.            No concomitant medications reported.  Treatment included a medication prescribed by the Cardiologist
Patient received dose one of Pfizer on 9 Sept, then his second dose was given as Moderna on 8 October. He reported his first dose as Moderna.
cough; slight difficulty breathing; This is a spontaneous report received from a contactable consumer (Patient). This 46-Year old (age at vaccination) female consumer (patient) reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 28Mar2021 as dose 1, single for covid-19 immunisation. Patient's medical history included seasonal pollen allergy. Concomitant medications were not reported. A 46-year-old patient received her first dose of the Pfizer-BioNTech COVID-19 vaccine on 28Mar2021, in the last 2 days she has experienced a cough and slight difficulty breathing, she asks if these are symptoms associated with the vaccine COVID-19, or if they may have been caused by her seasonal pollen allergy. A review of the EUA PI (LAB-1457-6.0, revised Feb2021) did not find information about cough and difficulty breathing (several days after vaccination) associated with the Pfizer-BioNTech COVID-19 vaccine. Per PI/Contraindications (LAB-1457-6.0, revised Feb2021), those symptoms are not listed as contraindications to the 2nd dose, but was referred to an HCP for individualized guidance, suggested to mention all her symptoms, medical conditions and relevant clinical history. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
HCP called to report a TE with PNEUMOVAX 23 PFS, GARDASIL 9, MMR II, VAXELIS PFS, ROTATEQ, VARIVAX. MMR was not supported and administered, and ROTATEQ was supported and also administered. No adverse effects reported. No additional AE.; This spontaneous safety report, with reference number 02450775 was received by the partner on 14-AUG-2023 and forwarded to company on 15-AUG-2023, from a health professional.  Due to the nature of the event, the causality between the event "HCP called to report a TE with PNEUMOVAX 23 PFS, GARDASIL 9, MMR II, VAXELIS PFS, ROTATEQ, VARIVAX. MMR was not supported and administered, and ROTATEQ was supported and also administered. No adverse effects reported. No additional AE." and Vaxelis was not applicable.   No further information is expected. Specific country product was not administered.  Non-significant Follow-up information was received by the partner on 16-AUG-2023 and forwarded to company on 17-AUG-2023, from a health care professional. This case is maintained as non-serious.  Due to the nature of the event, the causality between the event "HCP called to report a TE with PNEUMOVAX 23 PFS, GARDASIL 9, MMR II, VAXELIS PFS, ROTATEQ, VARIVAX. MMR was not supported and administered, and ROTATEQ was supported and also administered. No adverse effects reported. No additional AE." and Vaxelis was not applicable.  No further information is expected. Specific country product was not administered.
Within 16 hours, fever of 102, extreme fatigue, significant headache, body aches throughout, sore arm, chills, lymph nodes under arm receiving vaccine swollen, temperature of 100.5 48 hours later.
01/14/22 presents to EC ED for "fever, N/V, cough, myalgias, fatigue and diarrhea". PMHx of "HTN, Hyperlipidemia, Seizure Disorder, Asthma, CVA, Migraines, GERD, Chronic Lower Back Pain and Vertigo"
Hot to touch with redness over left deltoid, mildly tender with no other areas of redness.  Pt was seen at Urgent Care 09/15/2015.  Seen in our clinic 09/16/2015 where the redness had decreased in size.  Pt treated with Augmentin and Prednisone.  Also instructed to use topical Hydrocortisone 1% PRN.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with drug reaction/allergies to tetanus vaccine and drug reaction/allergies to sulfa. On 13-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J005068, expiration date 18-JAN-2015, 0.5 ml, intramuscular. No co-suspect and concomitant therapies were reported. Pharmacist reported that the patient developed a slight fever and an injection site reaction of redness, swelling and a "lump" (approximately in October 2014). At the time of this report, the patient no longer had the fever, redness and swelling but the patient still had a lump at the injection site. The outcome of injection site reaction was reported as recovering. The patient sought medical attention, called the pharmacist. No treatment was given for the adverse events. Additional information has been requested.
Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix) for prophylaxis.   On 23rd September 2022, the patient received Havrix. On 23rd September 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 26-September-2022 Reporter's comment: Reporter called to ask for information about the administration of an expired dose of Havrix to an 18 year old patient and asked for information about the wait time in order to repeat the dose. The reporter did not provide information about the lot number and expiration date of the dose of Havrix that was administered. Reporter consented to follow up. Additional supportive information. As patient was administered expired dose, which led to expired vaccine used.
On 02/04/2021, in the evening, I started to feel sick. In the middle of the night, I woke up about 03:00AM and went to take a breath and could not get the breath of air in. It did ease up. I was quite sick with fever, aches and pains, sore throat. I called my doctor in the morning. We talked about whether I should have vaccines in the future. When the boosters came along, he had me take ZYRTEC and other medications beforehand.
PATIENT GOT PFIZER PEDIATRIC VACCINE. SHE WENT OUT OF VACCINE AREA WHILE PARENT STAYED WITH YOUNGER SISTER FOR HER VACCINATION. PATIENT FELL BACKWARDS AND LAY DOWN ON GROUND. PEOPLE IN VACCINATION AREA GATHERED AROUND HER. PHARMACY STAFF CALLED 911.  PHARMACIST  OBSERVED GIRL LYING ON FLOOR TALKING TO HER MOM. EMT ARRIVED, TALKED TO AND PATIENT AND PARENT FOR 10-15 MINUTES AND LEFT.  THE PARENT AND THE PATIENT STAYED IN STORE SITTING DOWN FOR A FURTHUR 20 MINUTES THEN LEFT.
Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  dizziness and rapid heart rate.   Assessment : Time of assessment . 8:40am- Alert and oriented able to respond to questions but blank stare. Mom accompanying, at her side.She was discharged home on Wednesday from medical center after a 4 day stay for seizure like activity after passing out at home on Saturday. CT at hospital showed chronic sinusitis. Has continued with coughing and nasal congestion since discharge.    Actions taken: 8:43am- moved out of pt area and laid on stretcher. B/P 127/83, HR-66. C/O feeling hot. No breakfast or fluids taken in this AM. OJ given and water. 8:45am- Talking and laughing with mom still verbalizes dizziness. 8:49am-B/P 124/72, HR- 67. 9am- Sat on side of stretcher B/P 115/79, HR- 68, O2 sat 100% on room air. Verbalizes she feel some dizziness. 9:05am- Stood up,B/P 123/89, HR- 68 became very dizzy and unsteady on feet, immediately laid back down. Encouraged to drink water. 9:14am- Sat up on stretcher, no dizziness. B/P 118/67, HR-67. 9:17am- Stood up, denies dizziness. B/P-119/67, HR- 68. 9:18am- ambulating without complaints. No dizziness, HA, SOB and alert and oriented x4. 9:20am- Discharged home and will be home with mom all day, she has a post hospital f/u appt with her PCP today. Will relay with information to them.      Medications administered: No medication administered.
Tingling/pins and needles feeling in both hands and arms; Lightheadedness when standing up; Feeling spaced out; Unable to sleep first night after vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm right on 24Apr2021 at 08:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included Henoch-Schonlein Purpura, anxiety, depression and ADHD (Attention deficit Hyperactive Disorder) and allergy to sulfa drugs (sulfonamide allergy). Concomitant medications included ursodeoxycholic acid (ACTIGALL), omeprazole (PRILOSEC), famotidine (PEPCID), melatonin (MANUFACTURER UNKNOWN) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication from an unknown date. The patient previously took diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) in the left arm on 27Mar2021 at 11:15 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 24Apr 2021, first night after the vaccine the patient was unable to sleep. On 25Apr2021 at 11:00, the patient experienced Tingling/ pins and needles feeling in both hands and arms, light-headedness when standing up and feeling spaced out. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling/ pins and needles feeling in both hands and arms, light-headedness when standing up, feeling spaced out and unable to sleep first night after the vaccine were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, CoughWheeze, Fatigue, enlarged tender supraclavicular mass. Narrative:  Hx obtained by interview. Headache, muscle pain, fatigue, cough, productive mucus, and new enlarged tender easily visible mobile right supraclavicular mass likely a lymph node. Pain with, deep breath, or palpation anterior right chest. All moderate 1/22-23 and resulting unable to work half day 1/22/2021 and full day 1/23/2021. Improved gradually over course of week to date of report 1/28/2021 though persisting now mild. PMH "low" vitamin D. Denies HTN, heart disease, lung disease, DM, smoker. Advised productive cough with associated right side chest pain onset day after vaccination not expected adverse effect and should be further evaluated to r/o other etiology. Enlarged node may by related to a localized process such as URI rather than general adverse effect of vaccine. Sched private PCP f/u 2/1/2021.
This 73-year-old male subject was enrolled in a study. On 9th December 2013, the subject received the 2nd dose of Zoster VZV-gE-AS01B(intramuscular). On 8th October 2013, the subject received the 1st dose of Flu Seasonal QIV Dresden (intramuscular). The subject's past medical history included hyperlipidemia and hypertension. Concomitant products included Aspirin, atorvastatin, lisinopril and hydrochlorothiazide and metoprolol. On 10th March 2014, 91 days after receiving Zoster VZV-gE-AS01B and 153 days after receiving Flu Seasonal QIV Dresden the subject developed severe - grade 3 cerebrovascular event. Serious criteria included death. The outcome of cerebrovascular event was fatal on 10th March 2014. The subject died on 10th March 2014. The reported cause of death was cerebrovascular disorder. An autopsy was not performed. The investigator considered that there was a reasonable possibility that the cerebrovascular event may have been caused by Zoster VZV-gE-AS01B and Flu Seasonal QIV Dresden. Investigator comments: Hospital medical records requested. Death certificate indicates immediate cause of death to be cerebrovascular accident occurring on 10/MAR/2014 with no specific time indicated (under 1 day) due to or as a consequence of hypertension. No autopsy was performed. Patient has history of hypertension and hyperlipidemia since 2000 and was receiving therapy for both conditions.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cataract, Cataract operation (Left Eye cataract surgery), Surgery (Afib ablation) and Hysterectomy. Concurrent medical conditions included AFib, Hashimoto's disease, Hypothyroidism (Hypothyroid), ADHD and Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), PREDNISONE, LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, APIXABAN (ELIQUIS), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), VENLAFAXINE HYDROCHLORIDE (VENLAFAXIN), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and BUSPIRONE for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.
This spontaneous case, initially received from other non-health professional (consumer) on 30-Oct-2018, concerning an 83-year-old, elderly, female patient. The patient's current conditions included hypothyroidism, hypertension and hyperlipidaemia. The patient's concomitant medications included SYNTHROID, atenolol, LIPITOR, NORVASC, MVI and PRILOSEC. On 12-Sep-2018, the patient received first dose of FLUAD. On 25-Oct-2018, the patient was administered FLUAD TIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). It was reported that, the patient received second dose of FLUAD instead of the planned shingles vaccine (explicitly coded as wrong vaccine administered and inappropriate schedule of vaccine administered). On 26-Oct-2018, the patient experienced bad headache and muscle aches. The patient was treated with TYLENOL (as needed [prn]) and was monitored. The patient did not go to hospital, emergency room or after-hours clinic. It was reported that the patient saw her doctor and spoke with several other doctors regarding the events. On 30-Oct-2018, the patient had recovered from the event headache (resolved after 4 days) and on an unspecified date in 2018, the patient recovered from muscle aches (lasted for few more days). The reporter assessed the case as non-serious. Follow up received from other non-health professional (consumer) on 14-Nov-2018: The start date of the event headache was changed from 27-Oct-2018 to 26-Oct-2018. The start date of the event muscle aches was changed to Oct-2018 in the event tab. The patient saw her doctor and spoke with several other doctors regarding the events. The patient did not go to hospital, emergency room or after-hours clinic. It was reported that the patient had a bad head ache which resolved after 4 days and the muscle aches lasted for few more days. Hence, the stop date and duration of the event muscle aches was deleted from the event tab. The patient had completely recovered from the events. The narrative and case comment were amended accordingly.
I exp chest pain, rapid heart rate, dizziness, fatigue muscle/joint pain, brain fog lasting 2 months. I went to ER on 1/8, and have seen a Cardiologist, Allergist and Rheumatologist .I'm still exp brain fog as of today.
Very fast heartbeat (tachycardia): On 2/21/19, woken up at 4:30 am by a very fast, pronounced heart beat. On 3/19/19, sudden fast heartbeat (140-160) that wouldn't slow down, with extreme lightheadedness that almost caused fainting. Heart rate took about an hour to slow down to low 100s. Normal heart rate is 68.
Patient is a * year old * who received a single dose of J&J COVID 19 vaccine in the right deltoid.  Immediately following administration of the vaccine, patient began experiencing the sensation of heart racing, difficulty breathing, and feelings of anxiety.  Patient relates this has happened with vaccines received in the past, as she has postural orthostatic tachycardic syndrome (POTS).  She feels as if this is an aggravation of her POTS.  Patient states she has allergies/sensitivities to ciprofloxacin, bactrim, and sulfa drugs, but she has never needed to use epinephrine.  She denies chest pain/tightness, wheezing, swelling of the face/lips/mouth/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.  She does not take any medications on a daily basis.  POTS aggravation.  Patient was not displaying active signs and symptoms of anaphylaxis.  Patient?s heart rate and breathing continued to slow down once patient was brought to a quiet place and started to enact breathing techniques.  Vital signs continued to improve as patient sat.  Patient encouraged to consult her PCP and inform them of their post-vaccination reaction.  She was instructed to go to the emergency department if she should develop chest pain, difficulty breathing, swelling of the face/lips/airway, cramping abdominal pain with nausea and vomiting.   Patient discharged to home
Unusual adverse effect of multiple bruises forming afterward on upper left arm, not at the vaccination site but circling the arm. Otherwise, symptoms were severe but as predicted: sore arm within 5 hours of vaccination, chills within 8 hours, fever (reached 103F at about 11 hours after), extreme flu-like symptoms (fatigue, alternating chills and fever). I'm concerned only about the bruising.
My wife and I got our shots at the same time, with me going right after her. Suddenly, after 11 hours or so, she suddenly felt some tiredness, and moments later, I suddenly got weakness in both hands, which hasn't gone away yet. My forearms feel a little tight. It's been 2.5 days since it started. Otherwise, I feel relatively normal.