chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an office manager concerning her niece (a female autistic patient) who on unspecified date was vaccinated with the first and second dose of GARDASIL. It was reported that "after receiving the first and second dose of vaccine the patient experienced four to five seizures. The office manager stated that the patient had recovered. The office manager also stated that the patient went to a completely different office (medical practice) and they did not treat her at their office". At the time of report the patient had recovered. Upon internal review, seizure was determined to be an other important medical event. No further information is available.
difficult to walk; about pain on both legs; This non-serious case was reported by a physician via call center representative and described the occurrence of walking difficulty in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced walking difficulty (Verbatim: difficult to walk) and leg pain (Verbatim: about pain on both legs). The outcome of the walking difficulty and leg pain were not resolved.   It was unknown if the reporter considered the walking difficulty and leg pain to be related to Arexvy.   It was unknown if the company considered the walking difficulty and leg pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 19-OCT-2023 The reporter was a Medical Doctor who contacted GlaxoSmithKline representative stating a patient received Arexvy and called the clinic on 16th October 2023 to complain about pain on both legs and difficult to walk.  The reporter did not know when the symptoms started.  According to the patient, she felt fine on the morning and then the symptoms return in the afternoon.  The reporter consented to follow up.
Erythema 10 x 7 cm. Bruise. No fluctuant area.
a high fever; extreme fatigue; have allergies; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the first of eight reports. Only this report is serious.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisaton. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient was admitted to the ICU. The patient had allergies, but it was unknown  what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number can not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520700 same reporter/drug/AE, different patients;US-PFIZER INC-2020520703 same reporter/drug/AE, different patients;US-PFIZER INC-2020520699 same reporter/drug/AE, different patients;US-PFIZER INC-2020520704 same reporter/drug/AE, different patients;US-PFIZER INC-2020520705 same reporter/drug/AE, different patients;US-PFIZER INC-2020520701 same reporter/drug/AE, different patients;US-PFIZER INC-2020520702 same reporter/drug/AE, different patients;US-PFIZER INC-2020520700 same reporter, drug, events, and different patients;US-PFIZER INC-2020520701 same reporter, drug, events, and different patients
A consumer reported that her 21 year old son received a dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on 12/11/03 and developed a fever of 99.7 deg. F. and a runny , watery, yellow discharge from his right nostril. The reporter indicated that the pt has allergies.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 1 dose. The pt was not taking concomitant medications.  The pt received a dose of Engerix-B (hepatitis B vaccine) on 11/11/03 and 12/11/03.  On 12/11/03, a male pt received a dose of Flumist and developed a fever of 99.7 deg. F.  On 12/25/03, the pt developed a runny, watery, yellow discharge from his right nostril.  He was treated with Cefzil (cefprozil) for the "infection".  As of 12/29/03, the fever has resolved, however, the nasal discharge persists.
they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022; Dose administered after 30-day Use By Date AND after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date AND after manufacturer date of expiry) and PRODUCT STORAGE ERROR (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date AND after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date AND after manufacturer date of expiry) and PRODUCT STORAGE ERROR (they administered 7 booster doses of the Moderna Covid-19 Vaccine on 22Apr2022 from a vial expired on 16Apr2022 & had been initially refrigerated on 11Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on  11-Mar-2022. The vial did not undergo any temperature excursions.
Initial report received on 08/Sep/2006 from a nurse.  An 18-year-old female with no current illnesses, no known allergies, no pre-existing medical conditions, but who was taking Orth Tri-Cyclen had received a subcutaneous dose of Menactra, lot number U2135AA, in the right deltoid, on 05/Sep/2006.  Subcutaneous injection of Menactra are not a recommended route of administration by the manufacturer.  24 hours post vaccination, the patient developed redness and swelling at the injection site, and complained of flu-like symptoms.  Per the reporter, the flu-like symptoms only lasted one to two days.  At the time of this report, the deltoid area had become more red and swollen, and the patient was seen by a physician who prescribed an ointment.  The patient has not recovered from these adverse events. Follow-up information received on 10/Sept/2004. Per the reporter, the patient had not received any other meningococcal, diphtheria toxoid vaccine in the past. The MENACTRA was inadvertently administered subcutaneously on 05/Sept/2004. The patient has experienced a 10 cm area of erythema and heat at the site of the injection with no joint involvement. Flu-like symptoms, and presented malaise with fatigue. The patient was prescribed ALAVERT for seven days, and a antihistamine ointment as previously reported as treatment for the adverse events. Reportedly, the patient completely had a resolution of the adverse events when she had returned for an office visit in 11/Sept/2004. No further information is expected.
Expired Moderna was administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna was administered) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna was administered) had resolved.        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.   Concomitant medications were not provided Treatment information was not Provided.
Acute tinnitus in left ear a couple of days after receiving first dose of the Covid-19 Moderna Vaccine. One month later issue is not resolved.
Approx Oct 28th developed numbness with subsequent weakness lower extrem > Upper extrem. followed by bladder and bowel dysfunction. Dx with Guillain Barre Syndrome. RX with steroids and immunoglobulin.
Information has been received from a physician via a company representative referring to an unknown number of patients of unknown age and gender. Patients' concurrent and historical conditions were not reported. On an unknown ate the patients were vaccinated with GARDASIL (GARDASIL 9) (dose, frequency, route, lot # and expiration date were unknown). The physician reported that the patients were administered doses of GARDASIL one year apart (inappropriate schedule of vaccine administered). Concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
Information has been received from the authors in a literature article concerning an unknown gender 41 year old healthcare worker with MMR (manufacturer unknown) (route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evident of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 MMR vaccine doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at CH or at the facilities where patients presented. All positive samples from community laboratories were confirmed by County Health Care Agency (CHCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at CHCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (HI), and fusion (FI). The DPH viral and Rickettsial Disease Laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration. The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 18SEP96 9PM on 2OCT spiked temp of 104.1;temp range from 104.1 to 102.6 until 11am on 3OCT;had stuffy nose-gen redness on trunk-no rash was given APAP;
A physician reported the occurrence of a blister in a 15 y.o. female who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had no medical history, or concurrent conditions. She received no concurrent medications. The subject received her first injection of Hep B vaccine (brand unknown) in 1998 without any known adverse events occurring. On 10/16/02, the subject received her 2nd injection of Engerix-B (lot 5353B; expiry, 2/11/04). Three days later, on 10/19/02, the subject stated that she developed a blister above the elbow which was not at the inject site but in the same arm. The PT described the blister "as containing fluid and being surrounded by a ring of red." Reportedly, the blister broke open and released tannish-yellowish fluid. The physician stated that the affected area was 1.5 X 0.5 cm. As of 10/24/02, the events had "improved". Comment: The reporter stated that the Engerix-B lot # was 5353B; however, this is an invalid Engerix-B lot #.
ARM PAIN; BED RIDDEN; FEVER; BODY ACHE; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAR-2021 02:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 23-MAR-2021 22:00, the subject experienced headache. On 23-MAR-2021 22:00, the subject experienced body ache. On 24-MAR-2021, the subject experienced arm pain. On 24-MAR-2021, the subject experienced bed ridden. On 24-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, body ache, arm pain, bed ridden and fever was not reported. This report was non-serious.
Information has been received from a pharmacist concerning a 68 year old female with anaemia who in 2003 was vaccinated with PNEUMOVAX 23.  Concomitant therapy included EXJADE and PROCRIT.  On 13-OCT-2008 the patient experienced soreness and redness at the site and extend toward the back of the arm.  On 16-OCT-2008, the patient recovered from soreness and redness at the site and extend toward the back of the arm.  On 17-OCT-2008, the patient had a decrease in her hemoglobin to 9.3 and required transfusion of 2 units of packed red blood cells.  The patient's hemoglobin is normally in the mid 10's.  Upon internal review, decrease hemoglobin of 9.3 requiring blood transfusion was determined to be an other important medical event.  No further information is available.
Fever with chills, muscle aches, muscle cramps, muscle spasms, severe headache, insomnia, migraines, diarrhea, dizziness, ?brain fog?
We continued to monitor patient & gave water, BP came down, all Vitals stable & patent left
The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced intense, deep pain in upper left thigh. On 23-MAR-2021, the subject experienced headache. Treatment medications included: acetylsalicylic acid. On an unspecified date, the subject experienced chest discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intense, deep pain in upper left thigh on 26-MAR-2021, and the outcome of headache and chest discomfort was not reported. This report was non-serious.
Mother called and reported the following: 06/06/02 child woke up with red rash all over body. 06/07/02 mother took child to FNP. Dx no reaction to MMR gave RX for Atarax 1/2 sp q 4-6 hrs. 06/08/02 momther got Rx filled. 06/09/02 child awoke with swollen eyes and still had rash. Mother took child to hospital. MD inst. pt to cont with Atarax. 06/10/02 pt awoke with knot on right leg an an injection site and rash.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions or allergies reported. On unspecified dates, since 14-AUG-2015, the patients were vaccinated with doses of MMR II (lot# K024824, expiration date 02-DEC-2016; lot# K024036, expiration date 26-NOV-2015, doses, site and route of administration were not reported), which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Back pain started radiating down left leg, with stabbing pains, then up to rib cage, now upper rib cage and both sides of neck. All with random stabbing pains. Now seems to get worse daily.
TEN MINUTES AFTER RECEIVING VACCINE PATIENT COMPLAINED OF A TINGLING AND NUMB TONGUE. STATED IT WAS HARD TO FORM WORDS. HE ALSO STATED HIS THROAT WAS GETTING "HOARSE" AND BEGIN CLEARING HIS THROAT ALL THE TIME. ALSO   COMPLAINED OF SLIGHT TIGHTNESS OF THE CHEST AND THAT IT WAS HARD TO GET A FULL BREATH.  PATIENT STATED THAT  THE SYMPTOMS HE WAS  EXPERIENCING WERE THE SAME AS THOSE HE EXPIRENCED IN A PAST ANAPHYLACTIC REACTION.   PATIENT WAS PROMPTLY ADMINISTERED 0.3MG OF EPINEPHRINE VIA EPIPEN. FIRE/ RESCUE ARRIVED 5 MINUTES LATER. PATIENT REFUSED TRANSPORT TO HOSPITAL BUT INSTEAD WENT TO URGENT  CARE WITH WIFE. PER PATIENT HE  WAS GIVEN A STEROID INJECTION AND A SCRIPT FOR METHYLPREDNISOLONE  AT URGENT CARE. SPOKE TO PATIENT VIA PHONE 7 HOURS LATER AND STATED HE WAS DOING FINE.
This case was reported by a healthcare professional and described the occurrence of cut hand in a 56-year-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 June 2009 at 14:00, the subject received unspecified dose of ROTARIX and experienced cut hand and pharmaceutical product complaint. The reporter stated that the subject (a nurse) was cut when the ROTARIX vial shattered in her hand while preparing the vial for administrating to a patient. She put on a bandage and the cut is healing. At the time of reporting the event was improved. The healthcare professional considered the event was probably related to vaccination with ROTARIX.
A 42 y male with no known prior medical hx who presented to Hospital on 08/18/2021 w/ cough, blood tinged sputum, and dyspnea, found to have a new diagnosis of acute onset cardiomyopathy of unknown etiology w/ systolic heart failure (EF 20%), left ventricular apical thrombus, RML pneumonia, bilateral PE, and LLE DVT now transferred to hospital for further evaluation and workup of cardiomyopathy. On 8/26 event of thrombocytopenia in setting of initiating heparin thought to be heparin induced thrombocytopenia but can also be 2/2 vaccine induced thrombocytopenia.
Lymp nodes swollen in the neck area, underarm & clavicle area very tender & painful
Patient was complaining of a sore and itchy arm. I looked at it and it was hard, raised, and a white puss bubble at the site of injection of the shot. My husband took him to Urgent Care and was told it was a bad reaction to the shot and was given cephoflex for 10 days.
Reports headache & chronic HTN immediately after receiving dose #2. States HTN was managed by medication prior to receiving dose #2. Now Blood pressure runs 151/79 with persistent headache. Referred her to f/u with PCP.
Experienced shortness of breath, nausea Provided epinephrine IM per protocol at ~11:14 am and also Pepcid 10mg po dose.  Symptoms improved.  911 called, patient was transported to ED
A report has been received from a Health Professional concerning a 2 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 03-Dec-2013. Medical assistant reported that they inadvertently administered half of an expired dose of FLUMIST QUADRIVALENT to a patient on 03-Dec-2013. The outcome of the event of inadvertently administered 1/2 of an expired dose of FLUMIST QUADRIVALENT to a patient is unknown. The report was considered to be non-serious.
Initial unsolicited case received from physician (reporting for self) on 09-Nov-2015 and additional information received on 11-Nov-2015. This case involves a 65-year-old male patient, who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number-UI432AA, expiry date: 30-Jun-2016 and dose was not reported) in left deltoid on an unspecified date in Oct-2015. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions, other medical history and concomitant medications were not reported. On unspecified date in Oct-2015, 2 days after vaccination he experienced delirium for 2.5 days, was in bed and unable to eat. Patient also had pain at the injection site which was initially only minor. It was reported that 5-6 days ago he began to have severe pain and significant swelling in the left arm from his shoulder down the arm. He stated that the left arm was almost incapacitated. Later on patient reported that shoulder was still painful. No lab tests were performed. Corrective treatments were not reported. At the time of the report, patient had  recovered from delirium on unspecified date and not recovered from the other reported events. Upon internal review, case was considered as serious due to important medical event: delirium. List of documents held by sender: None.