chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seriousness criteria other medically significant (OMIC). Initial report received on 11/1/06 from a health care professional. A 45 year old female pt, with unk medical history, had received an IM injection of Fluzone SV 2006-2007 USP, lot number U2180AA, on 10/31/06. The site of administration was not reported. Four hours post immunization, the pt experienced itchy eyes and throat. Her eyes turned bright red and her face started to swell. The pt went to the ER and was treated with Solu Medrol, IV Pepcid, Benadryl, and Zyrtec. Diagnostic performed were not reported. At the time of this report, the pt was much better with only red eyes.
Itching, redness on injection site persisting for 4 days  pain around neck dizziness at time of injection but now pt is better
Patient discharged. The patient is an 80-year-old lady who presented to the hospital with chief complaint of diarrhea and dry heaving with hyponatremia.  She initially presented in early january and required admission to the intensive care unit with initiation of 3% normal saline.  She was discharged on 13th of January however since that time she had continued to have nausea and diarrhea and new onset shortness of breath.  She presented back to ER with concerns about recurrence of hyponatremia.  She was found to be COVID positive and was noted to desaturate to 87% room air and started on 1 L per nasal cannula.  X-ray chest showed the possible overlying pneumonia and hilar lymphadenopathy.She had an elevated procalcitonin and was started on antibiotics for community-acquired pneumonia and dexamethasone. She refused Remdisvir. She was subsequently transferred to hospital.  The patient was then noted to be hypoxic and was started on supplemental oxygen.  She was also continued on dexamethasone however she once again declined remdesivir.  The patient continued to improve and was subsequently off oxygen on day 3. The patient's imaging studies were reviewed x-ray showed evidence of hilar lymphadenopathy.  On going back on her CT scan from August of 2021 she had multiple nodules up to the size of 1.5 cm in the right lower zone.  I asked the patient if she had any follow-up down on that apparently she had gone to a pulmonologist and never followed up again.  I therefore spoke with the patient's primary care physician and updated him about the findings and the necessary follow-up.  The patient was also informed about these findings and the need to follow-up.  The patient was also found to have hyponatremia that is chronic and could be related to these findings.  She has been on sodium chloride tablets which were continued.  Workup confirmed the diagnosis of SIADH with an elevated urine sodium elevated urine osmolality and low serum osmolality.  The patient otherwise did well and was off oxygen and did well with room air and was subsequently discharged home.
Initial unsolicited case received from a nurse on 18 Jan 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, dose, route and site of administration was not reported) on 26 Sep 2016. The patient medical history and concomitant medications were not reported. On an unknown date, Culture confirmed Flu strain A. it was case of vaccination failure. The patient other lab tests and corrective treatment was not reported. The outcome of the event was not reported. Upon internal review the company decided to consider the case serious because of important medical events Influenza A virus infection and Vaccination failure. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with FLUZONE QIV vaccine and presented with influenza with culture confirmed for flu A strain. Time to onset is compatible, as patient should be protected with single dose, additional information regarding patient immune system at the time of vaccination, any defect in storage maintenance, technique while vaccine administration which may lead to vaccine ineffectiveness. Considering the temporal relation this is case of vaccination failure which cannot be ruled out as it is lab oratorically confirmed.
fatigue; States there was a pharmacist in from a temp agency and that pharmacist took an expired vial(expired one week prior) and diluted and gave to 6 patients; States there was a pharmacist in from a temp agency and that pharmacist took an expired vial(expired one week prior) and diluted and gave to 6 patients; This is a spontaneous report from a contactable pharmacist. A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0170, Expiration Date was not reported), via Intramuscular route of administration in left arm on 14Jun2021 at 09:22 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0178, Expiration Date was not reported), via Intramuscular route of administration in left arm on 22May2021 at 09:37 (at the age of 36-year-old) as dose 1, single for covid-19 immunisation and no reaction on previous exposure to Vaccine. It was unknown if patient received prior vaccinations within 4 weeks. The reporter states that she was a pharmacist speaking about the Pfizer COVID-19 vaccine. States there was a pharmacist in from a temp agency and that pharmacist took an expired vial (expired one week prior) and diluted and gave to 6 patients. Caller states the vaccine had no other excursions while being stored. She would like to know if the patients need to be revaccinated. Tried to warm transfer to Safety but no agents were available. Upon follow-up (23Jul2021), it was reported that pharmacists removed expired (clearly marked so) reconstituted & administered to 6 separate people. Vaccine was sequestered to destroy pending approval/acknowledgement Patients reported no adverse effects but did experience normal side effects in this case fatigue. Patient elected to not get another dose of vaccine. The outcomes of the events were unknown.  Follow-up (02Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up(23Jul2021): new information received from a contactable pharmacist in response to HCP letter sent via follow-up which included that: age at vaccination was updated. First dose date and time was updated, route of administration was updated, lot number was added. New event was added (fatigue).  Follow up attempts are complete. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021716440 same drug/reporter /events different patient
Upon second medical examination of the case during internal review, a significant correction was performed on 04 Feb 2015 to correct suspect drug INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE from INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE. Initial unsolicited report received from a non-healthcare professional on 16 October 2015. This case involves a 37-years-old male patient who was vaccinated with a dose of Fluzone ID (batch number: UT5350AA, expiry date: 30 June 2016) intradermally in left deltoid on 15 October 2015. The patient's illness at time of vaccination was reported as no and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as none. Concomitant medications were not reported. On 15 October 2015, few minutes following the vaccination, the patient had developed redness and swelling. On an unknown date (next day of vaccination), following the vaccination, the patient had lump under the skin the size of a golf ball, area is red and hot to touch. Laboratory data was reported as none and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
About 40 minutes after vaccine - had nauseam dizziness, fast heart beat and rash. Also had elevated blood pressure (elevated) and blurred vision.
At first she was just having fevers since Thursday night but on Saturday night her heartbeat was really fast so I went straight to the ER she was beating 178 beats which is highly fast and her fever was 103.4 the Dr said that that's a high fever just for shots and that the heartbeat was high too. They did some tests and everything came back ok so they linked it to the vaccines.
child recv vax 25APR97 & 2wk later mom devel what was suspected to be varicella;mom devel 4-5 small lesions on chin, wrist, & chest, t99.3, gen pruritus;this was considered secondary transmission;seen by MD 5MAY97;tx w/acyclovir;
2/19/21 - 12:00PM: Onset of soreness at injection site. 1PM: Fatigue. Feeling of pressure in head and ears, tinnitus and noise sensitivity, voice of spouse and my own perceived as metallic and computerized - as if talking through a device that distorts the voice intentionally; heart palpitations. 6PM: Fatigue. Chills and low grade temp ranging 99.5 degrees F. Joint pain (worst in knees and hips) - severe, low back pain - severe. 8PM - Temp 100.5 degrees. Onset of headache and stabbing pains in R parietal region. 10PM - Onset of stabbing pains in RUQ. 2-20-21 Sat: 8AM - Temp 99.6 degrees F. Chills. Soreness at injection site. Low back pain - severe, joint pain (worst in knees and hips) - moderate. Headache. Stabbing pains in RUQ. 6PM - Temp 99.3 degrees F. Soreness at injection site. Headache resolved. Stabbing pains in RUQ resolved. Feeling of pressure in head and ears with tinnitus, sound distortion, and noise sensitivity continue. Joint pain (worst in knees and hips) - moderate, low back pain - moderate. Mon 2/22/21: Cold sore eruption left lower lip. Feeling of pressure in head and ears with tinnitus, sound distortion, and noise sensitivity. Tues 2/23/21: Feeling of pressure in head and ears with tinnitus, sound distortion and noise sensitivity resolved. Wed 2/24/21:  Feeling of pressure in head and ears with tinnitus, sound distortion and noise sensitivity resolved. Thurs 2/25/21: Recurrence of feeling of pressure in head and ears with tinnitus, sound distortion, and noise sensitivity. Fri 2/26/21: Feeling of pressure in head and ears with tinnitus, sound distortion, and noise sensitivity. Sat 2/27/21: Feeling of pressure in head and ears with tinnitus, sound distortion and noise sensitivity resolved. Sun 2/28/21: Feeling of pressure in head and ears with tinnitus, sound distortion, and noise sensitivity. Mon 3/01/21: Feeling of pressure in head and ears with tinnitus, sound distortion, and noise sensitivity. Tues 3/02/21: Feeling of pressure in head and ears with tinnitus, sound distortion and noise sensitivity resolved. Wed 3/03/21: Feeling of pressure in head and ears with tinnitus, sound distortion and noise sensitivity resolved.  Thurs 3/04/21: Recurrence of feeling of pressure in head and ears with tinnitus, sound distortion, and noise sensitivity.  Reported to V-Safe at 7:42PM on Friday 3-12-21: Feeling of pressure in head & ears, R > L, with high pitch tinnitus, echoing of sound, sounds distorted as if listening through a seashell, voice of others and my own sounding metallic/computerized, and noise sensitivity ? all symptoms intermittent since 2-20-21.
ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 1/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Left arm is site of 1st injection- patient reports tingling and numbness in arm since first dose
Headache, increased pulse rate, 100.2 fever, irregular heart beat. Shaking, weakness
COMPLETE LEFT ARM NUMBNESS AS WELL AS SORENESS AT SITE.  TEMPERATURE, OVERALL MALAISE 24 HR
Started feeling so sick; He Is sick on the stomach/Is still sick; he could not go to work and has not gone to work; It got so bad last night; He is still sick; Nauseated/Nausea/felt like throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night) and ILLNESS (He is still sick) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concurrent medical conditions included Diabetes. Concomitant products included INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), INSULIN HUMAN (NOVOLIN R), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), GABAPENTIN, TIZANIDINE, OMEPRAZOLE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up). The patient was treated with ONDANSETRON (ZOFRAN MELT) for Nausea, at an unspecified dose and frequency. At the time of the report, MALAISE (Started feeling so sick), ABDOMINAL DISCOMFORT (He Is sick on the stomach/Is still sick), IMPAIRED WORK ABILITY (he could not go to work and has not gone to work), FEELING ABNORMAL (It got so bad last night), ILLNESS (He is still sick) and NAUSEA (Nauseated/Nausea/felt like throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that he takes lots of medications and reported taking "sugar" medicine.
Developed swelling, firmness, and red erythematous maculopapular rash on L arm on 7/21/19, the day following vaccination. Seen in office on 7/22/19, reportedly decreased swelling and redness per parental report following application of ice.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On 25-FEB-2015, GARDASIL of lot # K004205, expiry date 12-JAN-2017 and lot number K005881, with expiry date 14-JAN-2017 was improperly exposed to 21.72F for 40 minutes for 1 cycle. On unspecified date after this, in approximately 2015, an unspecified number of patients may have received this improperly stored GARDASIL. There were no known adverse effects. The vaccine was however, given via the correct route as per the prescribing information. The outcome of the incorrect product storage was unknown. This is one of the several reports received from the same source. Additional information has been requested.
5-month-old patient received a dose of FluLaval QIV on 21/Sep/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 4MM2J, expiry date 30-JUN-2024) for prophylaxis.   On 21-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 21-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 5-month-old patient received a dose of FluLaval QIV on 21/Sep/2023). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-OCT-2023 The reporter was a medical assistant. The reporter called to inform that a 5-month-old patient received a dose of FluLaval QIV, which led to inappropriate age at vaccine administration. Such patient was 14 days apart from turning 6 months. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
After the second dose of the COVID vaccine, the menstrual period arrived 10 days earlier.
PT GIVEN MMR RT LEG SUB-Q AND VARICELLA LT LEG SUB-Q. WITHIN 5 MINUTES PT HAD RASH AT BOTH INJ SITES. WORSE ON RT THAN LEFT. RT LEG W/ 3.5CM X 5CM RAISED, REDDENED AREA W/DIFFUSE REDNESS AT BORDERS. LT LEG W/ 3.5CM X 4CM FLAT, REDNESS W/ DIFFUSE REDNESS AT BORDERS. NO OTHER SYMPTOMS. PT GIVEN TYLENOL FOR COMFORT AND ICE TO AREA. PT OBSERVED X 30 MINUTES, STABLE AT THAT TIME. MOTHER INSTRUCTED TO RETURN TO OFFICE FOR F/U IN 24 HOURS.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (slight headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 immunisation. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jan-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (slight headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 30-Jan-2021, FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (slight headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Pfizer 4/5 and 4/26. Positive on 12/17
0.5 ml injected; No additional adverse events or quality complaints were reported in this case; 0.5 ml injected; a single dose of ROTATEQ was administered following a temperature excursion on March 12, 2021.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 12-MAR-2021, the patient was vaccinated, following a temperature excursion (product storage error), with a single dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1660944, which has been verified to be valid, the expiration date was reported and validated as 16-APR-2021), 0.5 milliliters (ml) injected (incorrect dose administered and incorrect route of product administration), as prophylaxis.  The vaccine was exposed to several temperatures below 2 Celcius (C) degrees (1.68 C and 1.11 C) and above 9 C degrees (8.49 C) for a time frame of 45 minutes, as recorded by digital data logger. There was no previous temperature excursion and no additional adverse events or quality complaints were reported.
MUSCLE TIGHTNESS IN LEG; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced headache. On 14-JUL-2021, the subject experienced fever. On 14-JUL-2021, the subject experienced nausea. On 15-JUL-2021, the subject experienced muscle tightness in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle tightness in leg, and the outcome of headache, fever and nausea was not reported. This report was non-serious.
last 2 days have been difficult; cold; Hot flashes; really bad shake; was so cold felt like his heart will come out of his chest; arm where the vaccine was administered is heavy/can't sleep on arm because it is uncomfortable; wakes up in the middle of night because he can't sleep, tossing and turning,; really hot; so worried because he does not know what this mean; can't even lift his arm; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (last 2 days have been difficult), NASOPHARYNGITIS (cold), HOT FLUSH (Hot flashes), TREMOR (really bad shake) and FEELING COLD (was so cold felt like his heart will come out of his chest) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced VACCINATION COMPLICATION (last 2 days have been difficult), NASOPHARYNGITIS (cold), HOT FLUSH (Hot flashes), TREMOR (really bad shake), FEELING COLD (was so cold felt like his heart will come out of his chest), LIMB DISCOMFORT (arm where the vaccine was administered is heavy/can't sleep on arm because it is uncomfortable), POOR QUALITY SLEEP (wakes up in the middle of night because he can't sleep, tossing and turning,), FEELING HOT (really hot), ANXIETY (so worried because he does not know what this mean), MOBILITY DECREASED (can't even lift his arm) and MYALGIA (arm hurts). At the time of the report, VACCINATION COMPLICATION (last 2 days have been difficult), NASOPHARYNGITIS (cold), HOT FLUSH (Hot flashes), TREMOR (really bad shake), FEELING COLD (was so cold felt like his heart will come out of his chest), LIMB DISCOMFORT (arm where the vaccine was administered is heavy/can't sleep on arm because it is uncomfortable), POOR QUALITY SLEEP (wakes up in the middle of night because he can't sleep, tossing and turning,), FEELING HOT (really hot), ANXIETY (so worried because he does not know what this mean), MOBILITY DECREASED (can't even lift his arm) and MYALGIA (arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
noticed redness & sl swelling around shot area (rt arm) p/vax;next day had rash on rt arm extending entire arm;resembled a heat rash;4th day rash on both arms;6th day noticed rash also on both legs extending entire legs x 4 days;