chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child received an expired ActHIB and Daptacel, no AE; Initial information received on 08-Nov-2019 and additional information received on 11-Nov-2019 and 12-Nov-2019  regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.   This case involves a patient of an unknown demographics who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: C5281AA, expiry date: 05-Oct-2019) and HIB (PRP/T) VACCINE [ACT-HIB] (lot: U1937AA, expiry date: 05-Nov-2019) via an unknown route in an unknown administration site.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  Reporter stated that he did not have any other information at this time, and did not know if it was 2 children receiving expired vaccine or if the same child received both.  At the time of reporting, no adverse event was reported.  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.
I had no symptoms until 28 hours after receiving my first dose I suddenly became faint and dizzy momentarily, lasted about 3-4 seconds.   I thought I was going to black out but did not, my daughter was with me so I know I did not actually black out.  Overall weakness, and fatigue like having the flu for the next 24 hours.   I did not seek medical attention at that time as I do not have a primary care provider.  I do intend on getting an appointment to be checked out as I cannot be certain this was due to the vaccine but I have never had this fainting feeling before.
Pt recv vax on 3/25/99; on 3/30/99 pt exp warm/ red area on left upper arm; tx=Keflex, Rocephin, Lidocaine, Dicloxacillin; dx=cellulitis
Initial information received from another manufacturer (service request number 1-7424967603) on 14 June 2013. The information was originally provided to the other manufacturer from a healthcare professional. A 01-year-old patient who had medical history of egg allergy and concomitant medications were not reported, had received a dose of FLUZONE (lot number, dose number, route and site of vaccination not reported) on an unspecified date. On an unspecified date after receiving vaccine, the patient had broken out in hives. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: None. Follow up information received from a healthcare professional on 26 July 2013: A male patient, had received a third dose of IPOL (batch number-"6/145" (invalid batch number), route of administration not reported) in the left thigh, a third dose of DAPTACEL (batch number: C4211AA, route of administration not reported) in the left thigh, a third dose of ACTHIB (batch number "UH624AI" (invalid batch number), route of administration not reported) in the left thigh, a third dose of PCV 13 (Manufacturer- Wyeth, batch number: F92471, route of administration not reported) in the right thigh and a third oral dose of ROTATEQ (Manufacturer- Merck, batch number: 0182EA), all on 21 November 2012. The patient had no illness at time of vaccination. The patient had no other medications. The patient had not experienced any adverse events following prior vaccinations. On an unspecified date, the patient had recovered from the event.
Fever, pain, swelling left deltoid & arm, sweats. weakness, Resolving.
Freezing with no fever; Started to feel like crap; Sore throat; Feel like coming down with bronchitis; Exhausted and miserable, Feel like coming down with something; Feel like coming down with something; slept for 45 minutes; slept for 12 hours; hangover headache next morning was not as bad; Bad irritability; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (chills), INSOMNIA (slept for 45 minutes), SOMNOLENCE (slept for 12 hours), HEADACHE (hangover headache next morning was not as bad) and IRRITABILITY (Bad irritability) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), VILAZODONE HYDROCHLORIDE (VIIBRYD) and VITAMINS NOS for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (chills). On 16-Apr-2021, the patient experienced INSOMNIA (slept for 45 minutes), SOMNOLENCE (slept for 12 hours), HEADACHE (hangover headache next morning was not as bad), IRRITABILITY (Bad irritability), FEELING ABNORMAL (Started to feel like crap), OROPHARYNGEAL PAIN (Sore throat), BRONCHITIS (Feel like coming down with bronchitis), FATIGUE (Exhausted and miserable, Feel like coming down with something) and FEELING ABNORMAL (Feel like coming down with something). On an unknown date, the patient experienced FEELING COLD (Freezing with no fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), INSOMNIA (slept for 45 minutes), SOMNOLENCE (slept for 12 hours), HEADACHE (hangover headache next morning was not as bad), IRRITABILITY (Bad irritability), FEELING COLD (Freezing with no fever), FEELING ABNORMAL (Started to feel like crap), OROPHARYNGEAL PAIN (Sore throat), BRONCHITIS (Feel like coming down with bronchitis), FATIGUE (Exhausted and miserable, Feel like coming down with something) and FEELING ABNORMAL (Feel like coming down with something) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-079271 (E2B Linked Report).
Information has been received from a physician concerning a female who on unspecified date was vaccinated with Gardasil and experienced nausea after the 3rd dose. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Periods have gotten longer and heavier. Getting them every 2 weeks and they last for 20 days.
Initial unsolicited report received from a consumer on 25 November 2015. This case involves a 69-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI477AA, expiration date: 20 May 2015, dose, dose number, route and site of administration were not reported) on 15 October 2015. The patient did not have known drug allergy. Concomitant medication was not reported. On 15 October 2015, few hours following the vaccination, the patient was feeling very bad, lost consciousness, severe shaking, vomiting and elevated temperature. On 15 October 2015, the patient's neighbor took her to the hospital. The patient required ER or doctor visit. It was reported that in hospital patient continued to have shaking, vomiting, elevated temperature, times in which lost consciousness, low blood pressure and she felt almost died. Laboratory investigations and corrective treatment were reported. The outcome of the event was unknown. List of documents held by sender: none.
Had varicella vaccine 2/21/97. Had mild case of documented chickenpox (office ) on 6/10/04.
Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022; Patient received a vaccine past the 30 day storage on the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Allergies included no known drug allergies.  Concurrent medical conditions included Type 2 diabetes mellitus and Hypertension.    On 30-Mar-2022 at 10:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022 at 10:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the 30 day storage on the refrigerator) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator/ Vial was initially stored in the refrigerator on 25-Feb-2022 and administered on 30-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient took Diabetes 2 and hypertension medications. On 25-Feb-2022 the vial was initially stored in the refrigerator, its 30 day used by date was 25-Mar-2022. The vial did not undergo any temperature excursions. It was reported that the patient not experienced any side effect. No treatment information was reported. The patient not had COVID-19 within last month.
14OCT92 redness-erythema & warmth beneath inject site 3cm x 5cm;  Occurred on 13OCT92 mom states redness was greater on 13OCT92 then on 14OCT92;
After receiving my second dose, I noticed a body rash appearing on my torso (chest, stomach, back) the second day. The rash is not itchy or raised, but is red. It has started to subside over the last few days.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's historical therapies included PREVNAR 13 on 09-AUG-2016. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-AUG-2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). On 27-FEB-2018, the patient was vaccinated again with the second dose of PNEUMOVAX 23, 0.5 ml, intramuscularly, lot# N025563 and expiration date: 08-APR-2019. There were no adverse effects reported.
Experiencing some numbness; This is a spontaneous report from a contactable consumer (patient) received via an automated system. This automated system responded via telephonic activity.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient experienced experiencing some numbness and was not sure if patient should call Pfizer,  or go to Doctor. Patient received the vaccine and was experiencing symptoms that patient had not heard about and was not sure if patient should go to the doctor or call Pfizer. Patient stated that he has been having numbness. The outcome of the event was unknown.   Information on Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Symptoms: 10/26/2001 "Woke up with aches and pain (all over) with sore throat".  No fever, lasted 3 days" 3 days later developed, "coughing, sore throat, hot and cold temperature 100 degree. No aches" took OTC Tylenol/cold for 5 days. Saw MD 11/07/2001.
I started having vertigo about 36-48 hours after receiving my second dose. I was so dizzy I was unable to get out of bed. It took me hours to be able to get out of bed. This lasted for a couple weeks.
Client was complaining about a "warm feeling." Complaint lasted about 10 seconds and resolved. No other complaints. No rash or allergic reaction seen. Patient stated he now felt normal. Heart rate was 90 and regular. Client refused any treatment or transport.
This is mom's statement over the phone on 8-6-07: Fever (101-103F) began within a few hrs of shots. On Fri, 8/3, a mild rash began. By Sat. rash was greater and by Sun, "there were more dots than baby." Appetite decreased. She took baby to ER where 3 docs thought it might be measles until contacted CDC who said, no, only if vaccine was compromised. We have had no other report of problems and cold  was kept intact.
mildly sore arm; felt washed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, dose number=1, lot is Unknown: not available/not provided to reporter at the time of report completion), administration date: 24Feb2021, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "mildly sore arm"; FATIGUE (non-serious) with onset 18Mar2021, outcome "recovered" (2021), described as "felt washed out". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, prior to vaccination, if the patient was diagnosed with COVID-19 and since the vaccination, if the patient had been tested for COVID-19. The response to the query included that reporter first became aware of this report on the day it was reported, thursday, March 25th, was in a meeting with several other people and they were talking about their recent vaccines and side effects that they did or did not experience and asked if any had received the Pfizer vaccine and two confirmed that they did. Patient had mentioned her side effects. The other person stated that they had no side effects from the vaccine, asked patient to provide the details on when and where she received her shots and the side effects she experienced, which she did and then submitted the report with the information she provided. For more information from her, email her and reporter dont have any other contact information for her.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that a 45 year old female pt received a Fluzone vaccination administered on 10/28/2001 two possible lot numbers were provided U0445AA or U07008AA. The pt reported experiencing flu-like symptoms in January 2002. Physician saw her; numerous tests done-possible diagnosis of chronic fatigue syndromes. Symptoms are unresolved. From follow-up report returned by the pt on 08/02/02, it was reported that she received a dose of Fluzone on 10/28/01 at a walk-in clinic. On 01/23/02, she experienced shortness of breath, fever, sore throat, swollen glands, chest pain, muscle aches, joint pain, jaw pain, and extreme fatigue. Pt also requested a copy of the report to be sent to her physician. Upon receipt of this info this report was upgraded from non-serious to 15 day.  A 15-day follow up report received 09/30/2003 adds: From additional info received on 09/15/2003 from an office administrator, the reporting physician's new address and fax number were provided. No additional relevant info was obtained. Adverse event coding was updated, and the provisional diagnosis (not confirmed) - Chronic Fatigue Syndrome - was coded. Follow up on 11/05/2003: "Case closure, on 10/27/2003.  A sixth attempt for follow up information was made on 09/15/2003, at which time the responsible physician was contacted via fax.  No response has been received.  No further information is anticipated, therefore, this case is closed."
This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 23-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient  received her first dose of the Pfizer covid vaccine and experiencing really bad fever, chills, headache, her arm hurts a lot. its been 3 days now and she still have bad headache and arm soreness, She said she is constantly taking Tylenol for fever. The outcome of the events were unknown.   No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated symptoms started late around 10 or 11pm on 03/30/23.  Patient described symptoms as pain in hip, knees, feet, back, hands and neck.  Patient described symptoms as really bad joint pain, body aches, fever and diarrhea.  Patient stated called PCP on 03/31 who instructed her to take Ibuprofen 800 mg and Extra Strength Tylenol. I informed the patient to alternate the medications. Patient denied signs and symptoms of anaphylaxis.  Patient stated she didn't feel well after first dose of Shingrix.
Aches; Inflammation on my left shoulder where I got the vaccine; Burning where I got the vaccine; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN (Lot Number: Not provided)), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Aches"; VACCINATION SITE INFLAMMATION (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Inflammation on my left shoulder where I got the vaccine"; VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "not recovered", described as "Burning where I got the vaccine". The events "aches", "inflammation on my left shoulder where I got the vaccine" and "burning where I got the vaccine" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain, vaccination site inflammation, vaccination site pain.  Additional Information: The patient had his second dose on 27Feb2021 and since then it was affecting his body and he had aches. He had inflammation on his left shoulder and burning where he got the vaccine. He did see his doctor and was prescribed with three medications but it did not help. He would have therapy next week (date unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 26JAN95 @ 10AM; mom called next morning w/report @ swollen, reddened arm w/fever of 104-105; mom gave APAP thru noc; dx seen again 27JAN95 & treated by MD accordingly
redness, rash at injection site developed after 5 days, continues to get bigger per patient
received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021; aches; shaking; weakness; mucous; This is a spontaneous report from contactable consumer (patient's wife) received from a Pfizer sponsored program report. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 25Feb2021 11:00 at age of 71-year-old (Lot Number: CH6202) at single dose for COVID-19 immunization in Urgent Care. Medical history included diabetes  from 2000 and ongoing. There were no concomitant medications. Prior Vaccinations (within 4 weeks), there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There was no events following prior vaccinations. The patient got the first dose of Pfizer COVID-19 vaccine and got COVID right after on 04Mar2021. The reporter believed they got it from the clinic. The patient was treated with monoclonal antibodies. The doctors have advised patient to take the second dose three months later. The patient received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021. Patient received antibody treatment on 05Mar2021. Patient had a positive PCR test on 17Mar2021. The patient experience aches that started on 28Feb2021 night after the vaccine. On 01Mar2021 he had a very high fever, it went up to 103.5 with paracetamol (TYLENOL). He could not get out of bed. No NDC Lot or expiration known for paracetamol. The patient had shaking, coughing, weakness and mucous which had all improved. He also had diarrhea, had some in morning of 21Mar2021 and it was still persisting. The events were reported as non-serious. The events required a visit to emergency room and physician office. The patient was not hospitalized and treated at Emergency Room with antibodies and sent home. The patient had positive Rapid COVID test and positive PCR COVID test. The patient underwent lab tests and procedures which included body temperature: 103.5 on 01Mar2021, COVID19: positive on 04Mar2021, PCR test: positive on 17Mar2021. The reporter assumed that patient got COVID 19 at the testing site because reporter knew of five other patients of reporter's own doctor who had that same experience in the same week. The outcome of COVID-19 and aches were unknown, outcome of shaking, weakness and mucous were resolving.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021313862 same reporter/product, similar events, different patients.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Metallic taste-Mild, Additional Details: Patient stated her chest felt tight and had a metallic taste in her mouth approximately 15 minutes after vaccination. She has had similar symptoms once after eating avocado. Resolved after given benadry. Contacted md for an epi pen rx for the patient to take home