chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe itching from injection site to fingers - treated successfully with ice  Significant constriction in throat and chest - from 15 min after and for a day and a half  Severe pain in neck/thyroid within 10 min of injection  Terrible taste in mouth within 15 min of injection - everything tastes terrible - lasts for 1 week.
Myalgia, Fever, NauseaVomiting, fever nausea body aches Narrative:
given vaccine 7/18 during the day Symptoms started 7:18 PM with cough,shortness of breath and sore throat. Symptoms progressed and she presented to the urgent care 7/21, Sent to ED and admitted at Hospital. On work-up, found to have leukocytosis to 15,000 on 7/21, imaging that showed chronic scarring at the bases from prior COVID infection and possible PNA. extended URI panel for viruses were negative. unclear if related to prevnar however, all symptoms started
2 hours fever, chills, & injection site reaction. Pt did not use anything to relieve symptom.
RED (ABOUT 6 INCH DIAMETER), HOT, PAINFUL KNOT.
The cases were received on 22 March 2014 at GPV. Initial misuse report received from a health care professional on 18 September 2013.  A 66-year-old male patient had received FLUZONE ID. It's an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none
received her first dose of the Pfizer Covid-19 Vaccine 2 weeks ago.  She tested positive for COVID-19 last week; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not on any medications or have any medical conditions that the reporter is aware of. The reporter does not know if the patient had any other shots on the day she got the Covid vaccine. The patient experienced received her first dose of the pfizer covid-19 vaccine 2 weeks ago. she tested positive for covid-19 last week on an unknown date in Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date in Aug2021. Outcome of the event was not recovered.  Information about lot/batch number has been requested.
Nauseated, pounding headache;  severe chest pain; trouble breathing; sharp quick repeated pain in my fingers, wrists, and feet; 100 degree temp; pelvic pain much more severe than I have ever had with Interstitial Cystitis = EIGHT HOURS
Information has been received from a nurse practitioner concerning an approximately 27 year old male who was administered three doses, subcutaneously, of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 01-APR-1982, 13 JAN 1990 and a third dose on 19 JAN 2004, and had a negative measles antibody IgG titer. The third dose of vaccine was administered in another country, and the NP was uncertain if measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) or mumps virus vaccine live (Urabe) (PARIORIX). Unspecified medical attention as sought. There was no product quality complaint. Additional information has been requested.
Barely lift her arm; Pain in arm after 2nd dose; This spontaneous case was reported by an other caregiver and describes the occurrence of LIMB DISCOMFORT (Barely lift her arm) and VACCINATION SITE PAIN (Pain in arm after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-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 LIMB DISCOMFORT (Barely lift her arm) and VACCINATION SITE PAIN (Pain in arm after 2nd dose). At the time of the report, LIMB DISCOMFORT (Barely lift her arm) and VACCINATION SITE PAIN (Pain in arm after 2nd dose) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Treatment medication was not provided concomitant product was not provided   This case was linked to MOD-2021-169645, MOD-2021-169645 (Patient Link).
10 days post vax pt devel hyperpyrexia associated w/unusual behavior, staring episodes & nuchal rigidity; pt admitted for full septic w/u which was negative; Pt also devel a erythematous macular rash for 3 days;
we gave pt the vaccine on day 16, at this time she is not experiencing any adverse events.
I got a blood clot in my right coronary artery. I had a heart attack and required catheterization. It was about 55 hours after the vaccine. I was in the hospital for a 3 day stay for observation. I am now on medication for it.
Patient potentially given overdiluted dose of COVID vaccine resulting in lower dose being administered than required.  No adverse effects.  Per CDC recommendations, will repeat dose.
Red, swollen, itchy warm to the touch. No fever, sore when lay on or touch. Quarter size of rash took a BENADRYL this am. Patient said the adverse symptoms did not happen until last Friday morning on Sept. 14, 2018, patient received the PREVNAR 13 on Sept. 7, 2018, Monday.
Vertigo I Saw my doctor regarding vertigo and he prescribed Meclizine HCI 12.5 mg 2 times a day. He checked my ears and they were fine. I am going to Physical Therapy April 5 to be evaluated.
This spontaneous report was received from medical assistant refers to a patient of unknown age and gender. The patient was vaccinated with dose 1, 0.5 milliliter (ml) PNEUMOVAX 23 (lot # not reported) intramuscularly (IM) on 04-JAN-2012. No concomitant medications were reported. The medical assistant reported that patient was inadvertently administered a dose of (dose 2) of PNEUMOVAX 23 (lot # not reported) dose and route not reported, on 04-OCT-2012. No adverse effects reported. No further information provided. Additional information has been requested.
A seeping sore appeared at injection site approximately the size of a dime.  I did nothing to it.  It scabbed over after a day or so, but 28 days later after the first injection, there is still a remnant of the scab and a white spot.  It did not hurt and I did not disturb or treat it - just let it heal on its own.  I noted this today when I was getting the 2nd shot and was asked to complete this online.
Moderna COVID-19 Vaccine EUA. The next morning I started feeling ill. Muscle aches and pains, low grade fever, but as the day progressed it got much worse.  I started to have excruciating abdominal pain. It was so bad that it was worse than childbirth. I had this same pain when I had Covid a year ago, which put me in the emergency room. I couldn?t eat anything but I was trying to stay hydrated. Today is Saturday and this started Friday morning. It is better today where I want to eat but I?m eating bland soft food. The body aches and pains are better but my abdominal pain is still there. Don?t know how long this will last. Each vaccine I?ve gotten I?ve had an extremely strong response and not in a good way. For the last two days I have not been able to get out of bed, very tired as well. Sleeping a lot.
Information has been received from a physician concerning a "14 year" old female patient who was hospitalized couple days for "Helicobacter pylori". On unspecified day she received second dose of GARDASIL (Lot # not reported). Concomitant therapy included VARIVAX and NEXIUM. After got the vaccine the patient felt like fainting. The patient sought unspecified medical attention. At the time of the report on 27-MAY-2009 the patient had recovered. Additional information has been requested.
Received 2nd pneumovax 7/23/02 in left deltoid area at the clinic. Developed redness (5.5"x5.5"), swelling and warmth left deltoid area. Cold compresses, Benadryl 25mg 4 a day. Ex. Tylenol 2 QID.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer BionNTech Vaccine on 06/18/2021 and 07/24/2021. Patient presented to ED on 8/1/21 for shortness of breath. Pt tested positive for COVID-19 on 7/30/21 and was positive for cough x 3 days. Pt was in respiratory distress in ED with worsening hypoxia requiring higher HFNC O2.Upon admission to the hospital she rapidly declined and required intubation and mechanical ventilation. Patient recieved lovenox for dvt ppx, decadron, remdesivir, and vancomycin. Her course was complicated by MSSA pneumonia and bacteremia.  She had persistent bacteremia and her lines were exchanged.She decompensated on the cont. ventilator and required continued paralytics and proning. Patient did not recover. Family decided to withdraw care and patient was extubated. Patient expired on 8/20/21.
01/21/21@11:15 client was given the Moderna vaccine and 20 minutes later client c/o being light headed, headache, and nausea. He also had a cough,  but there was no swelling presented and  his breathing was regular and unlabored. Vitals 132/82, 84, 20, o2 98%.  I did administer Benadryl (50mg/ml) for the itching (in the neck area). Clients safety was maintained at all times. Following the Benadryl (15-20 minutes) client stated "the itching stopped, no more nausea or coughing  presented. Breathing remained unlabored and O2 96-99%. Vitals; 128/80, 90, 18, O2 98%. With in 25-30 minutes client stated he was feeling better ( no headache or nausea). Client was then able to stand with no assistance and ambulate without assistance to the observation room with out assistance. He remained there for 30 minutes and a friend assisted him  home. I followed up in a hour and he made it home safe and stated he felt like normal.
Sudden hearing loss with tinnitus on the left ear, occurred about a month after 2nd dose of Pfizer. It went on for about 6 days without improvement and I went to see a ENT doctor who confirmed it to be SNHL. Prescribed with oral prednisone for two weeks. Recovered full hearing after the treatment.
Pfizer vaccine was administered outside of our facility - reported by patient-  NO LOT NUMBER WERE SUPPLIED  G47.33 OBSTRUCTIVE SLEEP APNEA 3/23/2022 ADENOCARCINOMA METASTATIC TO UNSPECIFIED SITE.
Chills beginning approximately 9pm; fever and vomiting by approximately 12:30 am of the 8th of April,  with vomiting continuing at approximately 1 1/2 hr intervals through till approximately 7:30 am. Was given water to sip while awake. Would sleep between vomiting. Still feverish until late morning (was given 500mg acetaminophen when vomiting seem to stop) During the night, he said that he felt like his heart was pounding.  By late morning, he did begin to feel and look better. Sore arm continued from evening of shot til  11th of April
Case number PHEH2013US023216 is an initial spontaneous report received from a pharmacist on 04 Nov 2013, with a follow up received from the pharmacist on 24 Dec 2013. This case refers to a 13-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 006011A and expiry date: Jun 2014) at dose of 0.5 ml intramuscularly in the deltoid on 01 Nov 2013 at 20:00 PM. No adverse event was reported following this administration error. Follow up received from the pharmacist on 24 Dec 2013: Site and time of vaccination was updated. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 24 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population.
On 3-2-09 parent called and reported that the child had a lump on her right outside thigh area. It was not red or sore. Lump under skin. There is a scratch on the leg in the same area.
Prolonged pain at injection site. Ibuprofen or naproxen plus ice was recommended and patient advised to follow up with doctor if pain persists.
Initial report was received on 01 December 2011 from another manufacturer (manufacturer report number A0953777A). The following is verbatim from the report: "This case was reported by a physician, via a GSK sales representative, and described the occurrence of fever in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX, HIB (non-gsk) and (non-gsk) PREVNAR. Concurrent medical conditions included pineal cyst. On 18 October 2011 the subject received 1st dose of PEDIARIX (.5ml, unknown route, left thigh), 1st dose of ROTARIX (details unknown), 1st dose of HIB (Non-GSK) (details unknown), 1st dose of PREVNAR (details unknown). On 19 October 2011, 1 day after vaccination with PEDIARIX, ROTARIX, HIB (Non-GSK) and PREVNAR, the subject experienced fever. The subject's parents reported the fever as high as 103 to 104 degrees Fahrenheit. The fever was only confirmed as high as 101.2 degrees Fahrenheit. The subject was hospitalised. The subject was treated with antibiotics. Relevant test results included negative results for urine culture, blood culture, cerebrospinal fluid culture, influenza virus test and respiratory syncytial virus test. On 22 October 2011, the event was resolved. The subject was discharged without fever after 3 days of hospitalization. The physician considered the event was possibly related to vaccination with PEDIARIX, ROTARIX, HIB (Non-GSK) and PREVNAR. Note: the ACTHIB, lot number OH289AA (invalid lot number) was reported by the other manufacturer as a sanofi pasteur product. Documents held by sender: none.
Fever, chills, aches, cough, nausea, swollen arm with warmth and diarrhea.
I usually bleed lightly now its heavy and clot as well.; menstruation heavy lasting over week; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 29Apr2021 11:00 (Lot Number: EW0151) at the age of 41-year-old as single dose for covid-19 immunization.  Medical history included none. The patient had known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced menstruation heavy lasting over week on 04May2021 12:00, it started on 25Apr-28Apr normal 3 day. The patient had shot taken on 29Apr2021. It (menstruation) restarted 30th and continues still of day of 05May2021. She usually bleed lightly now its heavy and clot as well on 04May2021 12:00. No treatment was received for events. Outcome of events was unknown.
Left armpit/axillae swelling. No redness or warmth. Treatment: symptomatic.
Last shot was March 17, 2021. On April 8, 2021 started having dizzy spells. On April 12, 2021, I had a dizzy spell, fell into door and vomited. Missed 2 weeks of work before a previous scheduled vacation took affect. Went to doctor and was diagnosed with Vestibular Neuritis. Was told it was unknown if this could have come about due to my receiving the Covid-19 Vacine
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: 06Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Sep2023 at 16:45, outcome "recovered" (02Oct2023) and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: home test showed positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30Sep2023 to 04Oct2023. Clinical course: On (PRIVACY) ship on cruise from (PRIVACY) to (PRIVACY), had cough and fever took home test showed positive, went to medical on ship.
One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion; One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (One of the vials was administered to a patient after the Pharmacist confirmed Temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided.
two days after receiving the vaccines, I, the patient began experiencing swollen lymph nodes, particulally around the throat that made it uncomfortable to swallow. They became more uncomfortable as they progressed, regardless of fluid/hydration. As of this current date, my lymph nodes are palpable vertically on both sides of my adams apple and along the sides of my jaw.
Information has been received from a doctor of pharmacy concerning an over 60 year old male physician with a history of chickenpox who on 25-FEB-2009 was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) (MSD) because of a name confusion.  The physician was not experiencing any known symptoms.  The patient did not perform any lab diagnostics studies.  The patient sought medical attention - visit to the pharmacy.  Follow-up information has been received from a doctor of pharmacy concerning a 63 year old male physician/patient who wanted to order a vaccine for himself.  The patient knew at the time he ordered the vaccine that he needed one shot.  He requested VARIVAX (Oka/Merck) thinking that only one shot was needed.  He administered himself the VARIVAX (Oka/Merck) and later realized that VARIVAX (Oka/Merck) required more than one shot in a series.  He then realized that what he actually needed was shot of ZOSTAVAX (Oka/Merck).  The patient did not experience any adverse event.  No further information is available.
patient administered expired dose of Pentacel vaccine/ NO AE; Initial information received on 22-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1-years-old patient who received vaccine 0.5 mL DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: UJ, expiry date: 14-Feb-2021 via an unknown route at an unknown administration site) (expired product administered) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.  Medical assistant asks for information regarding expiration of Pentacel and reports pontential adverse event and still not using product.  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.
Headache, Arthralgia, NauseaVomiting, Localized pain; fatigue, chills Narrative:
sore arm; fatigue; headache; Patient is not immunocompromised and received full  third dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient is not immunocompromised and received full  third dose of vaccine), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 028L20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus (Started 10 years ago).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient is not immunocompromised and received full  third dose of vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, ACCIDENTAL OVERDOSE (Patient is not immunocompromised and received full  third dose of vaccine), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            It was reported that patient had no improvement or worsening in the status of medical condition, it was same. No concomitant medications were reported. No treatment details were reported. It was reported that the patient was not immunocompromised but received full dose of 1st booster dose of vaccine.   This case was linked to MOD-2022-571116, MOD-2022-571129, MOD-2022-571131 (Patient Link).