chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines excursion, administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporters comment: Vaccine coordinator reported the vaccine excursion that was previous reported to be discarded, was administered to the patient in left thigh. The reporter did not consent to follow-up. Additional supportive information: The vaccine excursion that was previous reported to be discarded, was administered to the patient, which led to incorrect storage of drug. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022078361:Same reporter US-GLAXOSMITHKLINE-US2022078362:Same reporter
grandma stated rash starting 10 days p/vax;seen by MD viral exanthem rash probable secondary to MMR inj;
Information has been received from a physician concerning an approximately 40 year old female patient with no pertinent medical history and no known drug allergies, who on 24-JUL-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot : 662599/1076X). There was no concomitant medication. In 2009 the patient developed pain and swelling from elbow to shoulder of the arm where PNEUMOVAX 23 was administered. The patient sought unspecified medical attention. The physician did not have the patient's chart at the time of reporting. At the time of reporting on 27-JUL-2009, the patient status was unknown. The physician requested a lot check to be conducted because he does not feel comfortable using the vaccine. This is one of several reports from the same source. Additional information has been requested. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
itchiness and mild swelling in throat; itchiness and mild swelling in my throat; itchiness of face and neck with flushing; itchiness of face and neck with flushing; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FD8448), via an unspecified route of administration in left arm on 27Aug2021 11:30 (at the age of 36-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, Penicillin allergy, and latex allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC3181), via an unspecified route of administration in left arm on 06Aug2021 11:45 (at the age of 36-years-old) as dose 1, single for COVID-19 immunization and experienced itchiness and mild swelling in throat. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. The patient experienced itchiness and mild swelling in throat and itchiness of face and neck with flushing on 27Aug2021 12:15. The patient was advised to take Benadryl. The patient underwent lab tests and procedures which included Covid-19 RT-PCR (Nasal Swab): negative on 15Sep2021. Outcome of events was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Customer Comments:       Good Afternoon. We have a patient who received their first COVID-19 vaccination 21Sep2021, and their 2nd dose 07Oct2021, 5 days early. This is documented within both our database  and the patient's COVID-19 Vaccination Record Card. I can provide the patient's information if I'm contacted by email or phone. I have also informed the patient about this issue as well, and have asked the patient to return to the clinic to see what corrective actions can be done. I am asking for a response as the database will report that he's overdue for his 2nd dose beginning on the 28th, impacting COVID-19 vaccination reporting.
COVID-19 Patient noted to be COIVD (+) on 1/26 following 1st COVID-19 vaccination on 1/20 with no known exposure. Incidentally also with suspected pyelonephritis, suspected to be unrelated to vaccine as symptoms began earlier in the month
lightheadedness. Initial vitals BP 119/89, HR 80   ,RR 18, SO2 98 %.Denies chest pain, shortness of breath.  While on observation  EKG was performed showing Normal sinus rhythm, HR 86, Non-  specific ST-T waves changes, and evidence of Q wave in the inferior leads consisted with old MI. 30min vitals BP 114/73,HR 78,RR 18, SO2 98%.Patient recover well, recommendation to limit exertion was given until next Cardiologist visit appointment .Patient left vaccination center walking 13:06( patient refused a wheelchair) in stable condition
6 hours after vaccine, experienced fatigue and chills. Body temperature was good at 97 degrees F, but felt extream chills and aches. Took over the counter Tylenol and Aleve to help. Slept wrapped in comforter (unusual in SWFL). At about 3:00 AM chills subsided and removed covers. Woke at 6:00am feeling fairly normal again, 23 hours after vaccine.
Patient received "booster" 0.25 mL dose of Moderna vaccine 10/23/21 and experienced elevated BP (~190/160), heart palpitations, anxiety, and fever ~103 F beginning 24 hours post vaccination. Patient went to medical facility and was told by staff that she had an abnormal EKG, and she was subsequently referred to ER. At local hospital her blood work was evaluated for myocardial infarction, and all values were normal. She had a normal EKG at the hospital and was discharged. She continues to experience swelling in hands post-vaccination until present, making it difficult to wear rings.
Migraine headache extreme; This is a spontaneous report from a contactable consumer (patient reported for himself). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 14Aug2021 at 09:00 AM (at the age of 21-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 14Aug2021 at 01:00 PM, the patient had experienced migraine headache extreme. Reporter stated that adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with medicine (unspecified) for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 CLASSICAL HODGKIN LYMPHOMA, MULTIPLE LN SITES  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 HODGKIN LYMPHOMA, UNSPECIFIED TYPE AND SITE  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 ADENOCARCINOMA, DUODENUM  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 ADENOCARCINOMA, DUODENUM  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 ADENOCARCINOMA, DUODENUM  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 ADENOCARCINOMA, DUODENUM  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 ACUTE DVT OF BILAT ILIAC VEINS  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 LEUKOCYTOSIS  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 HODGKIN LYMPHOMA, UNSPECIFIED TYPE AND SITE  ACUTE DVT OF BILAT ILIAC VEINS 4/26/2022 HODGKIN LYMPHOMA, UNSPECIFIED TYPE AND SITE
non seroconversion; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 34-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number NL4J9, expiry date 14th September 2020) for prophylaxis.   Previously administered products included Engerix-B (1st dose received 6 month prior to the reporting date).   On an unknown date, the patient received Hepatitis B vaccine. On 23rd April 2019, the patient received the 2nd dose of Engerix B. On 23rd April 2019, not applicable after receiving Hepatitis B vaccine and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine.  Additional details were reported as follows: The age at vaccination was not reported for Hepatitis b vaccine. The pharmacist reported that patient had a prior Hepatitis b series, but showed no titer when drawn, was instructed to get another series.      Lab Comments: lab test were done on an unknown date
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There were no other medication in 2weeks. No Known allergies. The patient was treated with Paxlovid on 01Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300144513 Same patient, different drug, different event;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: Other medical history: Osteoporosis. Concomitant medication(s) included: GABAPENTIN, start date: Oct2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as a treatment for COVID-19 from 08Aug2022 to 13Aug2022. It was reported that patient received other medication in 2 weeks. No known allergies was reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Coivid-19 and drug ineffective.
rash-papular, entire body-devel rash distal to the inj site & spread over then entire body, papular in nature;used only topical cortisone rx;
60-80min after the vaccine of case of throat closing, running nose and coughing due to Throat. Took Benadryl and relieve symptoms but had to take several doses  Diarrhea , nausea, chest tingle / ache felt like electricity on the left side,  abdominal pain, arm pain (black and blue at I heat ion site)
This spontaneous report as received from a clinical medical assistant refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On 30-SEP-2014, reported as "yesterday", the patient was vaccinated with ROTATEQ dose 2, 2 ml, oral (lot # was not reported). The medical assistant stated that the administered dose of ROTATEQ was improperly stored. No adverse effects reported. No treatment was given. This is one of two cases from the same reproter. Additional information is not expected.
Patient fainted after getting COVID 19 vaccine.  Patient was sitting in chair.  Patient also gurgled.  Patient fainted after the first vaccine, but they still wanted to go ahead with the second vaccine.
swelling under my arm pit/reaction to the shot/I've had it for a couple months now; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swelling under my arm pit/reaction to the shot/I've had it for a couple months now) and HYPERSENSITIVITY (allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swelling under my arm pit/reaction to the shot/I've had it for a couple months now) and HYPERSENSITIVITY (allergic reaction). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swelling under my arm pit/reaction to the shot/I've had it for a couple months now) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.            Concomitant medications was not provided by the reporter. The patient did not remember when he got his first dose. He wanted to know if there were situations where it took an extended period of time for that swelling to go down. Treatment information was not provided.   Reporter did not allow further contact
Staff member stated that she had an allergic reaction "after the vaccine"...unsure of time frame and was still at work. She has a rash, hives and swelling around eyes....no immediate anaphylaxis. She verbally described her incident. Was treating with Benadryl (even though there was a stated allergy from 2013), then followed up with her family doctor, for steriod therapy on 12/18. She has not communicated with me further or have any absences from work at this time.
The pt experienced inconsolable crying with an onset of 3 hours post vax and lasting 3 hours.
Received Varivax 2/22/99 and on 2/15/05 developed chickenpox. Seen in office on 2/16/05.
Erythema at site & surrounding about cm in diameter from injection site (+) warmth with erythema.
reoccuring UTIs after the vaccine and had never experienced this in her past; This is a spontaneous report form a contactable Other Healthcare Professional. This Other Healthcare Professional reported for a female patient (reporter's mother) that: A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number were not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated on an unspecified date her mother had also had reoccurring UTIs after the vaccine and had never experienced this in her past. Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a medical assistant concerning a female with a codeine allergy who on 19-JAN-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot# 655619/1427F). Concomitant therapy included MICROGESTIN. On approximately 19-JAN-2007 the patient experienced dizziness and headaches for one week. Subsequently, the patient recovered from dizziness and headaches. On 23-MAR-2007 the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot# 657006/0188U) and did not experienced any symptoms. The patient sought medical attention by telling the physician about her symptoms. Additional information has been requested.
Abdominal pain and diarrhea for 3 weeks. Dizziness for first 2 weeks
impaired response to the Streptococcus pneumoniae vaccine; Literature report.  This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a to a 6-year-old male patient.  The patient presented to the immunology clinic with recurrent infections. He started to have recurrent otitis media at the age of 18 months. He also had multiple sinus infections and 34 episodes of pneumonia. Immunologic evaluation revealed an IgG of 498 (ref 6081229 mg/dL), an IgA of 20.8 (ref 33200 mg/dL).  He also has a history of eczema, chronic cough and environmental allergies for which he receives allergenspecific subcutaneous immunotherapy in addition to treatment with an inhaled corticosteroid and omalizumab. The patient also had persistent skin warts on his hands and extensive molluscum contagiosum lesions  On an unknown date, the patient started therapy with Streptococcus pneumoniae vaccine (pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection) administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced impaired response to the Streptococcus pneumoniae vaccine. T and B lymphocyte counts were normal. He was started on subcutaneous immunoglobulin replacement therapy after which his IgG level normalized and his frequency of sinopulmonary infections improved. He underwent targeted genetic testing for a primary immunodeficiencywhich revealed a hemizygous pathogenic variant in the magnesium transporter 1 (MAGT1) gene. The patient subsequently underwent a carbohydrate deficient transferrin test (CDT) for congenital disorders of glycosylation (CDG) that revealed moderately elevated transferrin monooligosaccharide to di-oligosaccharide and Apo CIII-1/Apo CIII-2 ratios, consistent with the diagnosis of MAGT1-CDG (XMEN; X-linked immunodeficiency with magnesium defect, EBV infection, and neoplasia).  The reporter considered impaired response to the Streptococcus pneumoniae vaccine to be related to Streptococcus pneumoniae vaccine (pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE)). The outcome of the event was unknown.  A copy of the published article is attached as further documentation of the patient's experience.
Patient came to pharmacy stating she got a reaction to the shingles vaccine - the blister/scab was on mid arm-tricep area - RPh stated she did not inject there.
Severe headache, Chills, 100.2 fever, body aches, Headache lasting several hours High fever lasting 1 hour Chills lasting 2 hours body aches continue as well as right leg pain 5 days after shot, lasting 3 days.  Called doctor, prescribed ibuprofen
Patient had low grade fever 2 days after shots but inconsolable crying (all day) lasting 5 days after that fever
This case was reported by a pharmacist via call center representative and described the occurrence of numbness facial in a 34-year-old female patient who received BOOSTRIX. On 3rd April 2018, the patient received BOOSTRIX. On 3rd April 2018, 15 min after receiving BOOSTRIX, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was recovering/resolving. The reporter considered the numbness facial to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The case was reported by the registered pharmacist. The pharmacist reports that his sister received a BOOSTRIX vaccine earlier today. The symptoms is improving.
Symptoms started 1-2 days after vaccination in the evening. Pain in right shoulder and rash, sores that healed only two weeks ago. Shoulder is still sore with pins and needles sensation, also says burning sensation. Numbness on the right side of neck and face. Patient tried neck exercises and ibuprofen starting 2 days after vaccination. Went to see Dr. and was given shot of toradol and cyclobenzaprine.  Went back a second time due to lack of response to cyclobenzaprine and was given another muscle relaxant (unknown). Has had high blood pressure for 1 month. Received a referral for physical therapy.
Information has been received from a woman from a physician's office concerning a pt who on 5/31/00 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629883/0042J). Subsequently, the pt experienced a temperature of greater that 101F. Unspecified medical attention was sought. Another pt was reported with an adverse event following vaccination with this same vaccine (WAES 00061850). The pt was lost to follow-up. No further information is expected.
mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-month-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "mild fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: children, vaccinated at 6 and 7 months, also Pfizer, had the kind of mild fever "that a single paracetamol solved". It was unknown if patient received other vaccine in four weeks. It was unknown if patient had COVID prior vaccination. It was unknown if patient tested for COVID post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Aug 10th- mild seizure. Aug 12th, 13th multiple seizures each day (partial complex seizure)- some loss of consciousness 30 seconds.
Feeling foggy after vaccine Vitals PO2 100% Temp 36.6 P 85 b/p 112/76 No treatment required left after 30 min observation AMA