chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient receive a dose of Flulaval instead of FLUZONE HIGH-DOSE QUADRIVALENT with no adverse event; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case received from pharmacist and non-healthcare professional via phone the Regulatory Authority (Reference number- 00832892).  This case involves a 72 year old female patient who received a dose of INFLUENZA VACCINE INACT SPLIT 3V [FLULAVAL] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect FLULAVAL not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination instead of  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  It was of actual medication error due to wrong vaccine administered (latency: same day).  It was reported "The Department of Health representative confirmed that we should re-dose the individual but asked that I contact you for guidance on when to re-dose. I would appreciate any information you can provide regarding how soon after administration of a sub-therapeutic dose of influenza vaccine, we should administer a therapeutic dose to this patient?"  At time of reporting, it was unknown whether the patient had any adverse event or not.  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 the 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.  There will be no information on batch number for this case.
developed severe throbbing headache; fever; chills; This is a spontaneous report from a contactable Physician (patient, self-reported).  A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9266 and expiry date was not reported), intramuscularly, administered in Arm left, on 04Mar2021, as DOSE 1, SINGLE for COVID-19 immunization (Age at vaccination: 70 years). The patient medical history included supraventricular tachycardia and history of NSTEMI. The patient had no known allergies. Concomitant medications included diltiazem hydrochloride (CARDIZEM CD) and salicylic acid, sulfur (SAS CARE). The patient was tested for COVID post vaccination. The patient was not diagnosed with COVID prior vaccination. On 04Mar2021, after 12 hours the patient had developed severe throbbing headache, fever and chills last 24 hrs. The patient underwent lab test and procedure which included covid test type post vaccination, nasal Swab with covid test result negative on an unspecified date. Outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Expirenced a period around 2 to 3 days early that was very heavy and painful 04/17/2021 at 12:50 pm. This period was much heavier and more painful than my normal periods, period started 04/16/2021 at 7:00 PM.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-DEC-2014, the patient was vaccinated with a expired dose of (Oka/Merck) VARIVAX, (lot number reported as H022155, Expiry date: 18-DEC-2014), 0.5 ml, intramuscular. No adverse effects were reported. Additional information has been requested.
AFTER THE SECOND DOSE I HAD CHILLS PAIN IN MY ARM ADN HAD FEVER AND FATIGUE AND TIRED FOR ABOUT 24HRS. IN AUGUST I STARTED DEVELOPING CHEST PAINS AND THEN I WAS HOSPITALIZED. THE CHEST HAPPENS REGULARLY AND I HAVE BEEN DOCTORS AND THEY RAN A COUPLE OF TESTS BUT NOTHING WAS FOUND.
TIA  stroke like sysmptom went to ER hospitalized Goa a day in hospital
Felt Nauseous and then collapsed onto the floor and was unconscious for 4-5 minutes.
Sore throat; Pain at the injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 12:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the 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 four weeks prior to the vaccination. On 19Apr2021 at 13:00, immediately after vaccination, the patient experienced pain at the injection site. On 20Apr2021, the patient experienced sore throat. On 21Apr2021, the patient's arm felt better but sore throat remained. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event pain at the injection site was resolving, whereas the event sore throat was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Woke up around 3 am with body aches; Headache; Woke up around 3 am with chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Woke up around 3 am with body aches), HEADACHE (Headache) and CHILLS (Woke up around 3 am with chills) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced MYALGIA (Woke up around 3 am with body aches), HEADACHE (Headache) and CHILLS (Woke up around 3 am with chills). At the time of the report, MYALGIA (Woke up around 3 am with body aches) and HEADACHE (Headache) had not resolved and CHILLS (Woke up around 3 am with chills) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  On 01-Nov-2022 around 3:30 pm, patient received the bivalent COVID booster shot.  At the night around 3 am, patient woke up with chills and body aches. Patient still had body aches and a headache in the morning.
Headache, nausea, vomiting, chills, muscle aches, fatigue. Very hard to sleep. Vomiting was the worst symptom. Could not eat or drink entire day after vax. After a tele-health visit with on-call nurse and urgent care doctor (facilitated by my wife), prescription for Zofran was given. This helped. Took Zofran and ibuprofen once I was able to keep it down.   1st day after vax - headache, nausea, vomiting, chills, muscle aches, fatigue.  2nd day after vax - headache, queasy, muscle aches, fatigue. 3rd day after vax - muscle aches, fatigue - worked from home briefly, but didn't do any other daily tasks 4th day after vax (today) - still a bit achy and fatigued, but able to go about normal daily tasks, etc.
Mother reports chest pain (resolved when seen), regressive behaviors, headache, tingling of hands.
This spontaneous report as received from a pharmacist refers to a 13 years old non-pregnant female patient. The patient's concurrent conditions included asthma and allergy to amoxicillin and cefdinir. Concomitant therapies included albuterol, ADVAIR, FLOVENT and ZYRTEC. On 18-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 (intramuscularly, lot # reported as L004014 (verified to be non-valid lot # for GARDASIL 9), expiration date 04-MAR-2017; dose was not reported). In August 2015, the patient experienced injection site reaction. The patient visited an unspecified physician and reported that the injection site on her upper arm was red and warm to touch. The physician did not prescribe a treatment, however he told the patient to keep an eye on the injection site to make sure that the redness did not get worse. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and the vaccination with GARDASIL 9 was not reported. Additional information has been requested.
SWELLING OF FACE, TONGUE, ARMS AND HANDS; VOMITING; NAUSEA; ABDOMINAL PAIN; SWELLING OF FEET; COULDN'T SLEEP; ITCHY RASH; DIARRHEA; PAIN ALL OVER; SORE THROAT; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no underlying medical conditions.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced pain all over the body, sore throat. On 12-APR-2021, the patient experienced rash. On 13-APR-2021, the patient experienced diarrhea, itching. On 14-APR-2021, the patient experienced abdominal pain, swelling of feet, could not sleep. On 15-APR-2021, the patient experienced swelling of face, tongue, arms and hands, nausea and vomiting. She went to clinic to see a doctor and doctor told the patient to go to ER. In Emergency room, they gave her intravenous fluids and medicine for the nausea and vomiting. All her symptoms were improving but she was worried that she will still have swelling and rash with the itching. She only slept for about 4 hours at night. She did not have insurance and medical bills got expensive and was worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 15-APR-2021, was recovering from abdominal pain, diarrhea, pain all over, sore throat, and couldn't sleep, and had not recovered from swelling of face, tongue, arms and hands, swelling of feet, and itchy rash. This report was serious (Other Medically Important Condition).  .; Sender's Comments: V0;-covid-19 vaccine ad26.cov2. s-swelling of face, tongue, arms, hands and abdominal pain. This events are considered unassessable. The events had a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
patient reports arm soreness for 1 week accompanied by bright-red, hot rash which extended from deltoid down to elbow.
FELT SICK; NAUSEA; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced nausea. On 22-MAR-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, nausea and felt sick was not reported. This report was non-serious.
Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling very weak; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; She felt a little pain; rash or redness; Got the sweats after the chills; having weakness in her legs, the muscles and joints.; Having weakness in her legs, the muscles and joints.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO162), dose 1 via an unspecified route of administration,  on 22Apr2021 13:00 as 1st dose, single (at the age of 86-years-old) dose on left arm for COVID-19 immunization. Medical history included prosthesis on the right arm 7-8 years ago, that is why she gets everything done on the left arm. And got COVID-19 virus, then she got the antibodies intravenously applied. The patient's concomitant medications were not reported and she would rather not give her list of medications. On 22Apr2021, after vaccination, the  patient had reaction. The  patient also had pain at the injection site injection, site swelling and redness that went down her arm, was tired, had muscle pain, chills, joint pain, difficulty breathing and weakness in joint. After getting the shot she felt a little pain, then a rash or redness that kept growing and growing; she felt it was little swollen. The patient stated that she got so chilled she had to put on 4 layers of clothing and 2 blankets. Then she got the sweats after the chills, so much that you could wring it out of her clothing. She reports feeling very weak and had the chills, then she went to bed and woke up with the sweats. The patient also having weakness in her legs, the muscles and joints. It was reported that everything went away after about a week, gently. At the injection site she had swelling and redness that went down her arm that lasted 2 weeks and went away. The patient furthermore stated that  "she is not going bald but, losing her hair a little and the color of her hair changed from dark brown to all white now, it happens when one gets old they shrink, go bald or lose your hair". The patient was  scheduled to receive second shot on 12May2021 at 11:00. She went to her pulmonary doctor due to having trouble breathing. They increased her medication for her breathing which helped a lot. Therapeutic measures were taken with medications for dyspnea. The patient recovered from all the events.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer and described the occurrence of pain in a 52-year-old male subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The reporter is the wife of the subject. A physician or other health care professional has not verified this report. The subject's medical history included asthma and disc herniation. Concurrent medications included Fluticasone propionate+salmeterol xinafoate (Advair), Salbutamol sulphate (Albuterol) and Naproxen. The subject had received influenza virus vaccine in previous years and experienced minor soreness at injection site. The subject had no adverse events following receipt of any other type of immunizations. On 17 October 2007 at 1:12 p.m., the subject received unspecified dose of Fluarix. The consumer reported that the subject inadvertently received this dose of Fluarix in the "joint space of the shoulder instead of the deltoid." As a result of this inadvertent administration into the joint space of the shoulder, the subject experienced drug administered at inappropriate site. The consumer reported on 09 November 2007, that the initial reaction was severe pain followed by barely being able to move the arm. The reporter also noted that the subject "Was initially put on light duty at work." The date of onset of these adverse events was not reported. The subject was seen at a physician's office. The consumer considered the events to be disabling and to jeopardize the subject or require intervention. At the time of reporting the pain and difficulty moving the arm were unresolved.
Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 36 years old patient who experienced patient was administered vaccine that had been out of recommended temperature range for 8 days, while he/she received vaccine TYPHIM VI. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2018, the patient received a 0.5 ml single dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot NIK811M; expiry date: - 19-Oct-2019 via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was not reported whether the patient experienced any adverse events or not. 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 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. Documents held by sender: none
Other mild side effects; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other mild side effects) and INJECTION SITE PAIN (Pain in the injection site) 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 VACCINATION COMPLICATION (Other mild side effects) and INJECTION SITE PAIN (Pain in the injection site). At the time of the report, VACCINATION COMPLICATION (Other mild side effects) and INJECTION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.   Reporter did not allow further contact
Vaccine was given to patient at 10/07/2022 for first dose pfizer kid. Vaccine was set to expired 1 year after manufacture date which was 09/30/22. We went by BUD 10 weeks after received vaccine which will expired at 10/30/22. The vaccine had been recalled by pharmacy on 10/13/2022 for all LOT and NDC. The manufacture data supported that vaccine is stable and effected so revaccination is not indicated and patient notification is not required at this moment.
it has been more than 36 days since the first dose and patient had not gotten the second dose; in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath) and PRODUCT DOSE OMISSION ISSUE (it has been more than 36 days since the first dose and patient had not gotten the second dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath) and PRODUCT DOSE OMISSION ISSUE (it has been more than 36 days since the first dose and patient had not gotten the second dose). At the time of the report, CHEST PAIN (in his chest and heart whenever he took a deep breath/pain in his heart whenever he took a deep breath) had resolved and PRODUCT DOSE OMISSION ISSUE (it has been more than 36 days since the first dose and patient had not gotten the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment details were reported.
Small hard bump appeared 6-15. Today, 6-16, it is bigger and harder. Feels kinda like a pregnancy bump but in my arm. Feels warmer than other skin around it. I believe this came from the HPV vaccine, because I think my tetanus shot was higher up on my arm than the bump is, and I know the HPV shot was lower than tetanus.
Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with ETODOLAC at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency and MUPIROCIN at an unspecified dose and frequency. On 01-Apr-2021, HERPES ZOSTER (Shingles) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt complained of excruciating pain that traveled up her neck, but wasn't sure if it was from immunization or the metal hardware that is becoming loose in her neck.
7 days after vaccine left arm was red, puffy, itchy and warm and sore to touch with fatigue.  It was gone after 5 days
Diarrhea; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and FATIGUE (Extreme fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and FATIGUE (Extreme fatigue). At the time of the report, DIARRHOEA (Diarrhea) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.   Reporter did not allow further contact
her neck is hurting; headache; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (her neck is hurting) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (her neck is hurting) and HEADACHE (headache). At the time of the report, NECK PAIN (her neck is hurting) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact