chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pneumonia near died from it; got the flu, influenza A; bronchitis; Initial information was received on 11-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional (patient).  This case involves a patient of unknown age who experienced pneumonia, flu, influenza A (influenza) and bronchitis, when the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications and family history were not provided.  The patient's past vaccination included first flu shot (INFLUENZA VACCINE) for prophylactic vaccination and had flu (Influenza). It was reported that the patient never had flu in life till he/she got flu shot 3 years ago and was told that patient picked up the virus prior to getting the shot..   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced pneumonia, flu, influenza A (influenza) and bronchitis, (unknown latency) following the administration of INFLUENZA VACCINE. It was reported as next year patient got flu shot and was near died from these events. Patient never got flu shot again. Seriousness criteria was assessed as medically significant as per important medical event (IME) list for the event pneumonia.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events was unknown.  Information on the batch number requested for this case.; Sender's Comments: This case concerns a patient of unknown age who presented with pneumonia, Influenza A virus infection and bronchitis (latency: unknown) after vaccination with INFLUENZA VACCINE. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
pt recv vax 10JUN96 & 20MAR97 pt exp mild case of chicken pox w/red papules, small bumps from head to toe & two open lesions;
Stabbing chest pain 3 days after vaccination. Chest felt heav; pain to the left arm, left amr went numb for 2 hours. Patient developed a lump without tenderness that lasted 5 days. No SOB, HA, dizziness, blurred vision, abdominal pain or nausea, vomiting, or diarrhea.
Subsequent to receiving vax, pt developed numbness and tingling of her hands and feet lasting for 3 months.
Hives, swelling of face, muscle aches,  nausea, migraine,
Nausea, dizziness, fever, chills, arm red, warm, sore surrounding administration site. No treatment.
Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she have a man in there church that he received Shingles vaccine and he experienced so sick with the vaccine. Follow-up would not possible as no contact details were available.
Throwing up,every muscle and joint in my whole body hurt, chills, sweats, couldn't eat. All this lasted 2hrs and then I started to get better, but I was so sick I debated about going to the hospital but decided not to due to covid lock down
a 22-year-old female patient received an expired dose of Menactra; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from a Other Health Care Professional.  This case involves a 22 years old female patient who received 0.5 ml single expired dose of MENINGOCOCCAL VACCINE (MENACTRA) (lot: U5839AA, exp date: 05-MAR-2019, via intramuscular route in the Left Deltoid).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications was not there.  It was of actual medication error due to expired vaccine used.  It was not reported whether adverse event was experienced.  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.  List of documents held by sender: none.
On Monday, January 25, 2021, at 11:40am I received the second dose of a series for the Pfizer COVID-19 vaccine. Over the course of the rest of that day, I began to develop a headache and mild neck soreness. That night, I slept poorly. When I awoke just before 5:00am the next day, Tuesday, January 26, I did not feel well. I was experiencing headache, malaise, nausea, myalgia, arthralgia, and low-grade fever. I called my supervisor around 5:30am that day and we decided it was best that I stay home to recuperate. Throughout the day, I mostly rested and slept, took Tylenol, and began to feel better in the mid-afternoon. I did call and leave a voicemail for hospital Employee Health around 1:30pm on Tuesday the 26th, but did not hear back. Today, Wednesday, January 27, I am feeling much better, and well enough to come to work.
1302: 1st dose Moderna vaccine administered 1309:  Client stood up from chair, reported feeling nauseous, and immediately had syncope episode- NP able to ?catch? client and assist him to the floor where she put his legs up. Client did not sustain injury from assisted fall. Pallor appearance. Verbal and A&Ox4. Ice packs applied.  1310: HR 62 with thready radial pulse, PERRLA 4mm, RR 10, BP 108/68 1314: HR 68, PERRLA 4mm, RR 10, BP 108/72 1320: Client moved to couch, reports still feeling shaky and anxious. Says his hands feel like they are cold. Felt warm/even upon palpation. Water & graham crackers given  1325: Client reports feeling better and told us he was anxious about the vaccine and did not drink any water today. 1330: HR 72, PERRLA 3mm, RR10, BP 116/78, normal skin tone, extremities warm  1340: Client says he feels normal again and understood to seek medical assistance for any follow up issues. Client understands that this was not an allergic reaction and is eligible to receive 2nd dose in 28 days.  1343: Client left site without further complication.
really sore arm; arm was not as sore; muscle ache; Joint pain; Headaches; Fatigue, stayed in bed; fever of 101.3 °F; like a light case of the flue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a light case of the flue), PAIN IN EXTREMITY (really sore arm), PAIN IN EXTREMITY (arm was not as sore), MYALGIA (muscle ache) and ARTHRALGIA (Joint pain) in an 81-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 RIVAROXABAN (XARELTO), GABAPENTIN, ATENOLOL, TRAMADOL and LINACLOTIDE (LINZESS) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (like a light case of the flue), PAIN IN EXTREMITY (arm was not as sore), MYALGIA (muscle ache), ARTHRALGIA (Joint pain), HEADACHE (Headaches), FATIGUE (Fatigue, stayed in bed) and PYREXIA (fever of 101.3 °F). On an unknown date, the patient experienced PAIN IN EXTREMITY (really sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 06-Mar-2021, INFLUENZA LIKE ILLNESS (like a light case of the flue), PAIN IN EXTREMITY (arm was not as sore), MYALGIA (muscle ache), ARTHRALGIA (Joint pain), HEADACHE (Headaches), FATIGUE (Fatigue, stayed in bed) and PYREXIA (fever of 101.3 °F) had resolved. At the time of the report, PAIN IN EXTREMITY (really sore arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Case number PHEH2014US024998 is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 12 years old male patient. Past medical history and concomitant medications were not reported. The temperature excursion of FLUVIRIN (batch number: 145701) began around 16 Oct 2014 and the patient received the vaccine intramuscularly at a dose of 0.5 ml on 18 Nov 2014. It was reported that the vaccine administered was at 49 F 12 times over a period of 34 days. There were 12 separate temperature excursion lasting 30 minutes each in which the temperature was 46 to 49 F during each of those excursion. No adverse events were reported following the maladministration.
Rash at injection site. Started small, injection site became a hive with an occasional itch and some redness around. Minimal pain, warm to touch. Has changed in size over past 24 hours. Area of redness increased over time, hive/raised skin decreased though skin still feels warm and swollen to the touch. Itch went away.
Bilateral edema of legs from knee down, with 10 lb weight gain. Muscle twitching noted during fluctuating weight loss period. Employee is still in process of weight loss. PMD in process of performing blood and urine testing.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with  improperly stored doses of PNEUMOVAX 23 lot # M036728 with expiry date 20-MAY-2018 and lot # L033707 with expiry date 18-MAY-2017 (dose and route of administration were not reported) for prophylaxis. The doses were exposed to 51 Fahrenheit (F) for 14 hours 23 minutes. Digital data logger was involved. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. This is one of 4 reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014600: US-009507513-1612USA014601: US-009507513-1612USA014444.
SEVERE PAIN INTIALLY, HAS DECLINED TO MODERATE BUT CONSTANT LEVEL OF PAIN FOR MORE THAN 2 WEEKS POST VACCINATION
Patient received Pfizer vaccine for dose 2 in series instead of Moderna. Patient received Moderna for dose 1 on 12/30/2020. He was inadvertently given Pfizer for dose 2. The error was caught almost immediately. The immunization clinic team notified the clinic's medical director immediately upon identifying the error and informed the patient of the error.  The patient was provided verbal and written information and advice concerning the medication error.  During the 15-minute post-vaccination monitoring, the patient reported that he had no untoward effects from receiving the pfizer vaccine. Clinic director had contacted the patient via telephone at 8 pm that same evening and the patient reported no untoward effects from the pfizer vaccine.  The patient was advised that given the CDC's current recommendations, an additional dose of either vaccine is not recommended at this time and antibody testing for determining vaccine efficacy is also not recommended at this time.  The patient voiced understanding.
5" x 5 1/2" red, warm area on left upper arm where Varivax #2 was given.
skin rash, fever, chills, shortness of breath, palpitations, body aches, fatigue
Swelling to eyes and lips and wheezing. He received Albuterol Neb treatment x 2, IV Benadryl and IV Solumedrol. Admitted for 23 hours observation.  1/16/07 Received medical records from hospital which reveal patient admitted 11/30/06 angioneurotic edema, SOB & wheezing following vax.  Treated w/nebs, IV Benadryl & steroids w/improvement.  Admitted for 23 hour observation. FINAL DX: anaphylactic reaction s/p immunizations.
The patient presented 3 days after receiving the 2nd dose of Moderna vaccine with chest pain. Initially, the patient was started on Heparin drip, a beta-blocker, high-intensity statin, and aspirin.  Cardiac MRI showed evidence of myocarditis with normal biventricular systolic functions. An echocardiogram showed a normal Ejection fraction with apical hypokinesis. The patient was discharged on aspirin only. In the last follow-up visit, the patient denies any recurrence of chest pain.
Had horrible reaction/still red; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced erythema (Verbatim: Had horrible reaction/still red).  The outcome of the erythema was not resolved.   It was unknown if the reporter considered the erythema to be related to RSV vaccine.     It was unknown if the company considered the erythema to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 26-SEP-2023 This case was reported by a patient via interactive digital media. The patient had a horrible reaction from that shot it lasted for over a month still red. Follow-up was not possible as no contact details were available.
PT had injections, went home. Napped 5 hrs and woke with inconsolable crying for 1/2 - 3/4 hr.
died; This is a spontaneous report from a non-contactable consumer, this consumer report same events for 5 patients, this is the fifth of five reports.  A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Reporter said they tried to say nurse didn't die, but she had an obituary so she clearly did die so that's just one, reporter had seen 4 self.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101524663 same reporter/product/event, different patient; Reported Cause(s) of Death: died
bad headache; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 22Dec2020, the patient experienced bad headache. The clinical outcome of the bad headache was unknown.   No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report was received from a Medical Assistant referring to an unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. The reporter stated that on an unspecified date, 4 doses of improperly stored ROTATEQ orally, lot # M039061, expiration date on 28-APR-2018 (Strength and dose  number were not provided) for prophylaxis had been administered to the patients. It was reported that the dose of ROTATEQ was improperly stored at 47°F to 77°F for 50 minutes. This excursion was detected due to a digital data logger. No adverse effect was reported. Additional information has been requested.
UTI; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (UTI) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Nitrofurantoin and phenazopyridine
This spontaneous report was received from a pharmacist concerning a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M035147, expiration date 25-OCT-2017, dose and route of administration were not reported) reconstituted with expired sterile diluent (lot # L002440, expiration date 15-JAN-2016). No adverse effects were reported. Additional information has been requested.
Received Pediarix, HIB, and Prevnar vaccines at about 10:30 on 5/15/2006. Went home and a couple hours (less than 2) later had an episode of stiffening, with purple color change and not breathing. This lasted less than 1 minute. It recurred about 10 minutes later, lasting less than 1 minute. No fever. Cried loudly after episodes. No crying at start of episodes.
patient already received a flu vaccine on 9/12/23 per system. This was discovered during billing after vaccine was given on 10/25/23.
Cold, severe cough, copious phlegm, wheezing. Robitussin, Mucinex, cough suppressant w/codeine, then doxicycline, then amoxicillin.  Began to improve but after 3 1/2 days on amox., severe shaking started.  Neurologist said it looked like full-blown Parkinsons.  Stopped all meds. until some improvement in shaking occurred.  Still improving as of 11/16/2011 but not to prior condition.
Clinical Summary Patient is a 74 y.o. female with a history of bronchiectasis and RA who presented to hospital 10/24/2022 with cough, fever in setting of positive home COVID testing. Found to be hypoxic. Patient left against medical advice 10/26/22.   1. Sepsis: presented with fever, tachypnea. Lactate and WBC WNL in ED. Likely d/t COVID PNA. S/p Empiric IV abx coverage with cefepime and doxycycline in ED, continued on admit in setting of her bronchiectasis. Urine Ags negative. Blood Cx NGTD. Urine Cx contaminated. Sputum Cx with many gram negative bacilli. Pulm followed. 2. Acute hypoxic respiratory failure: in setting of COVID PNA on baseline bronchiectasis, requiring 2LPM per NC in ED though O2 in ED on RA initially 81%. Tx of COVID as below. Home O2 eval ordered. Consulted pulm in setting of her known bronchiectasis  3. COVID-19 pneumonia: Positive testing 10/24/22, vaccinated (x4 vaccinations total, last 4/2022 but no bivalent booster). Presented with fatigue, dry cough and fever. CTPA with multifocal infiltrates on baseline bronchiectatic changes. Decadron and Remdesivir started on admit given her O2 requirement. Baseline inflammatory markers CRP 50.2, ferritin 282. Required special isolation.  4. Bronchiectasis: known h/o. Does not follow with pulm. Not on inhalers at home. No longer on daily abx. Pulm followed. 5. Elevated troponin: denied any chest pain on admit. Trop 86 -> 90. EKG in ED trended with findings more c/w LVH on repeat. Had initially started on heparin drip given her abnormal initial EKG and elevated trop, stopped given delta flat and less concerning for NSTEMI, more likely d/t demand ischemia in setting of above. Started heparin gtt. TTE without WMA. Cardio followed 6. Elevated BNP: 3817 in ED. Without any findings c/w HF nor any h/o HF in the past, appeared somewhat hypovolemic on admit. TTE 10/25/22 with EF 62%, diastolic function indeterminate.   7. Hyponatremia: Na in ED 130. Unclear etiology, possibly d/t poor PO intake and sepsis. S/p IVF bolus in ED. Resolved.  8. Hypokalemia: K in ED 3.3. in setting of poor PO intake PTA. S/p replacement. Improved 9. Rheumatoid arthritis: denied any recent flares of RA. On chronic steroids with prednisone 10mg daily, held on admit in place of Remdesivir. Consider taper off of prednisone as O/P but defer to rheumatologist.
Extreme fatigue and body aches for 12 hours. I tested positive for COVID-19 on 12/18/2022. I had a headache for the first 2 days. I have phlegm in my throat and was fatigue for 3 days. My provider prescribed medication LAGEVRIO. I did a telehealth visit with my provider over the phone.
Approximately 2 days after receiving the vaccination patient reported red petechial like rash beginning on her legs and spreading to abdomen and arms.
Daughter developed a fever, small red spots all over her body, sore throat, poor appetite, and irritable. These symptoms appeared approximately 8-10 days after vaccination was given.
wife had very mild COVID Disease; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (wife had very mild COVID Disease) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (wife had very mild COVID Disease). In 2022, COVID-19 (wife had very mild COVID Disease) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient received 4 Moderna COVID-19 vaccine so far. The last Moderna COVID-19 shot was administered on 07Apr2022. Patient only had a little cough and patient was fine after a few days. Patient was confused about Monovalent and Bivalent. Patient will go on a cruise on 04FEB2023 and require up to date vaccination records.  No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-706625 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2023-706625:Husband case