chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to mushrooms, non-alcohol user, and cigarette smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-AUG-2021, patient experienced symptoms of fever and fatigue (suspected clinical vaccination failure and covid-19 infection). On 23-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive.(covid-19 infection). The action taken with covid-19 vaccine was not applicable. The outcome of the covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846633.; Sender's Comments: V0:20210849794 - covid-19 vaccine -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
c/o of worsening pain around lt shoulder inj site w/severe pain & inability to use lt arm;no relief w/APAP or topical rub;
fainted for approximately one minute; weakness; dizzy; Dose number=3; Dose number=3; Day of injection sore arm.; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old non-pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 01Oct2021 14:00, at the age of 69-years-old, (Lot Number: Fc3184) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation.  Medical history included Recovering cancer patient, and post heart surgery patient.  The patient did not have COVID-19 prior the vaccination. There were no concomitant medications. Historical vaccine includes dose 1 of BNT162B2 received on 25Jan2021 on left arm (lot number: EL 9261), and dose 2 received on 15Feb2021 on left arm (lot number: Pfizer en6201).  On 01Oct2021, the patient experienced injection sore arm for 1 day. On 02Oct2021, the patient experienced dizzy then fainted for approximately one minute then weakness throughout that day. The outcome of the events was recovered. The patient was not tested for COVID-19 post vaccination. No treatment was received for the events.
Localized reaction (Rt deltoid) to PNEUMOVAX. Patient reported to PCP after 72 hrs. Patient advised to take BENADRYL by PCP after office treatment.
infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black; Pain; This spontaneous case was reported by a patient and describes the occurrence of LOCALISED INFECTION (infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 044A21A and 022M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (4 heart attacks.). Concurrent medical conditions included Allergic reaction to bee sting and Coronary heart disease.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOCALISED INFECTION (infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black) (seriousness criterion disability) and PAIN (Pain). The patient was treated with Surgery (Toe amputation) for Localised infection. At the time of the report, LOCALISED INFECTION (infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black) and PAIN (Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient stated that patient had 3 doses (Which included two booster). Patient had an infection in the left foot. In the left foot 2 of patient's toes had remove due to the infection (the right toe and the one next to it) in 01-Nov-2022 or 04-Nov-2022. Patient was a disabled "Private". Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 56-year-old, male patient with current condition of Coronary heart disease and medical history of four heart attacks, who experienced the unexpected serious (disability) event of toe infection. The event is reported in relationship with the administration of mRNA-1273 vaccines. Latency could not be assessed due to lack of information. It is reported that patient required amputation of two toes and one more toe is also infected and in turning black. Mentioned medical history could be a risk factor and confounder for the event, however very limited information was provided. Further information was requested. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Each time my identical twin sons were given a vaccine (they had the ones for RSV also), they got worse and worse until at 18 months of age, they were unmanageable and I didn't understand why.  3/16/09 MR received for both patients with DX:  Autism-relatively high functioning. Pt A has some decreased muscle tone on exam.  Pt B making significant progress. Developmental exam deferred. Follow-up: They still have autism. Quit requiring the shots!
Hematospermia, with no hematuria, dysuria, or dyspareunia. No recent sex, one female partner, oral sex only. Unlikely to have recent covid or other infection; I've been on vacation (at home, no travel) but did 2 days in non-COVID19 ICU on 1/5 and 1/6. Last intercourse one week ago, with no symptoms. ROS otherwise negative. On self-physical exam, no tenderness of testes, penis, suprapubic region, CVAT. Exam otherwise negative; unable to perform prostate exam on self.
1 of 2 pt who recvd DTaP/OPV/PPD w/in 24 hrs p/vax devel an inject site reaction which included erythema, induration & pain; erythema was 3" in diameter; no fever; required office visit; tx included APAP PRN; recovered;
Chronic debilitating demyelinating polyneuropathy. Tx: DECADRON, LYRICA
pt recv vax 11APR97 & 19APR97 pt devel less than 50 lesions & a very low grade fever;
Patient was indicated for pneumonia vaccine however since she is under 65 years old she should have received the Pneumovax 23 instead of the Prevnar 13.
Full body hives spread out only about 10 in total lasting more then 24 hours. Red blotchy non bumpy rash on both arms lasting more then 24 hours. Heavy feeling in chest lasting more then 24 hours. Severe muscle and joint aches lasting more then 24 hours. Extreme tiredness lasting more then 24 hours. Brain fog lasted less then 24 hours.
Purpuric type rash to abdomen, bilateral legs and arms.  Moderna Vaccine was at a Site on 3/28/21
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 01-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
Red rash in area where he had PNEUMOVAX 23 vaccine. Reported the day after receiving the vaccine.
presenting with rash to the left thigh and chest pain that began 2 days ago. Symptoms began 2 days ago after the patient received vaccines for poli, varicella and the flu. The rash is itchy.
Patient did not feel good Saturday morning (Sept 26). Like he had fever and feeling sick. H drove himself to the hospital and he got there he felt his throat tightening. He got ZV Benadryl and Cortisone and was released same day.
flu; Initial information was received on 19-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an unknown age female patient who experienced flu after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with lot number, strength, formulation, dose not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken : Not Applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.; Sender's Comments:  SanofiPVPortal20221220000617:
Local arm pain close to injection site; dizziness; back pain close to elbow to the head; Diarrhea; vomiting; headache; burping; bitter taste in mouth; body aches; weakness; farting; tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 07Feb2021 15:00 (age at vaccination: 51 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypertension and thyroid cancer. Concomitant medication(s) included levothyroxine sodium 88 mcg; losartan potassium (LOSARTAN) 100mg and gestodene. On 09Feb2021 10:00, the patient experienced local arm pain close to injection site, dizziness, back pain close to elbow to the head, diarrhea, vomiting, headache, burping, bitter taste in mouth, body aches, weakness, farting and tiredness. The patient on 15Jan2021, underwent sars-cov-2 test (nasal swab) which was negative. There was no other vaccine in four weeks. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DEAFNESS (medically significant), outcome "unknown", described as "lost all hearing in his right ear". Additional information: Forwarded as an Adverse Event by the Escalation team on 09May2022. Reporter provided verification of contact address on 08May022. Customer Verbatim: Hey my dad got your corona vaccine as per (name withheld). He lost all hearing in his right ear immediately after the vaccine. The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Ultrasound revealed venous blood clot (DVT).; she developed pain, redness and swelling in lower left leg.; she developed pain, redness and swelling in lower left leg.; she developed pain, redness and swelling in lower left leg.; This is a spontaneous report from a contactable physician. A 71-year-old non-pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EN5318), intramuscular, administered in the left arm on 02Feb2021 at 13:00 as single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot Number: EL1283), intramuscular, administered in the left arm on 19Jan2021 at 13:00 as single dose (age at the time of vaccination 71-year-old) for covid-19 immunisation. The patient's medical history included hypothyroidism and penicillin allergy. The patient's concomitant medications included thyroid hormone. Patient did not receive any in vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID tested post vaccination. On 02Feb2021, she developed pain, redness and swelling in lower left leg. Ultrasound revealed venous blood clot (DVT). No other cause was found-not on hormones, negative hyper coagulable work up, no trauma or prolonged sedentary status. Therapeutic measures were taken as a result of the events and she was treated with blood thinner (Eliquis). The outcome of the event ultrasound revealed venous blood clot (DVT) was unknown, and other events was recovered with sequel.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of "Deep vein thrombosis" due to temporal relationship and current known drug safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Red itchy rash; Red all over/ felt like a Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number 27KF5, expiry date 10th June 2021) and (batch number 2RC9S, expiry date 10th June 2021) for prophylaxis.   On 20th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced itchy rash and vesicular rash. The patient was treated with ibuprofen, cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the itchy rash and vesicular rash were recovered/resolved.   It was unknown if the reporter considered the itchy rash and vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient had a dose of Shingrix then for 5 days it was red all over from his back to his chest and up to his neck and ears and also on his scalp, visible since he is bald. It felt like a Shingles rash The patient saw a doctor and received for 5 days Zyrtec during the day and Benadryl at night.  The patient also had ibuprofen the day of the injection. The reporter did not consent to follow up.
Extreme body aches and joint swelling  Sever headaches, fevers for 4 days 100.3-103. Full leg and finger cramping  High blood pressure and racing heart beat
rash came back at the injection site and ran to the back of arm and up to her cheek; rash was itchy; also experienced shortness of breath; red hive at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (rash came back at the injection site and ran to the back of arm and up to her cheek), RASH PRURITIC (rash was itchy), DYSPNOEA (also experienced shortness of breath) and INJECTION SITE ERYTHEMA (red hive at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2014, Cancer surgery (Breast Cancer) in 2014 and Radiotherapy (Breast Cancer) in 2014. Concurrent medical conditions included Asthma.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red hive at the injection site). On 24-Jan-2021, the patient experienced CONDITION AGGRAVATED (rash came back at the injection site and ran to the back of arm and up to her cheek), RASH PRURITIC (rash was itchy) and DYSPNOEA (also experienced shortness of breath). The patient was treated with CORTISONE in January 2021 for Adverse event following immunisation, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) in January 2021 for Adverse event following immunisation, at a dose of 1 dosage form and METHYLPREDNISOLONE on 16-Jan-2021 for Adverse event following immunisation, at a dose of 4 mg. On 22-Jan-2021, INJECTION SITE ERYTHEMA (red hive at the injection site) had resolved. At the time of the report, CONDITION AGGRAVATED (rash came back at the injection site and ran to the back of arm and up to her cheek) and RASH PRURITIC (rash was itchy) was resolving and DYSPNOEA (also experienced shortness of breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was provided by the reporter   This case was linked to MOD-2021-021201 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received included no new information.
8/15/21: admitted. presented to the ER for further evaluation of Vomiting and diarrhea for the past week. tested positive for covid on 8/15/21. diagnosed with covid 19 pneumonia.  Note, patient previously vaccinated with J&J vaccine on 3/13/21.  8/21/21: Discharged to home.
Significant rash on bilateral arms and legs. Significant swelling of the right arm. Immune response. Rash at the time of the event- I suspect she will improve every day.
more than 36 days have passed since getting first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days have passed since getting first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Jan-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days have passed since getting first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days have passed since getting first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-036120 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273.
and in the morning he developed some swelling in the same area (near the armpit); a day after he began to have pain under his armpit; The next day he presented with some inflammation around the armpit area; This is a spontaneous report from a contactable consumer. This consumer (wife) reporting for a 43-year-old male patient (husband) reported that: A 43-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0183), via an unspecified route of administration in right arm on 23Jul2021 (at the age of 43-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0173, Expiration date: 31Aug2021), via an unspecified route of administration in right arm on 30Jun2021 (at the age of 43-year-old) as dose 1, single for COVID-19 immunisation. It was reported that on behalf of her husband who received the second dose of Pfizer's COVID-19 vaccine on last Friday, a day after he began to have pain under his armpit and in the morning, he developed some swelling in the same area (near the armpit), this reaction occurred in the same arm where he received the vaccine. She wants to know if these are side effects reported with the vaccine. The next day of vaccination (24Jul2021), he presented with some inflammation around the armpit area and some pain in that area as well and she gave him ibuprofen. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Admitted for bilateral atypical pneumonia with acute hypoxic respiratory failure secondary to COVID-19 pneumonia; tx w/remdesivir, O2, steroids, abx, zinc; weaned to RA for dc home.
Deep pain in right arm, Diarrhea, up set stomach, vomiting, fever.
11/24/2019  site sorness began 11/26/2019 under arm began 11/28/2019 a swollen welt about the size of a half dollar coin developed with red rash on welt, and was very itchy.
The patient received FLUAD IM vaccine on 12/5/18 at approximately 11:40 AM. At 12:00 PM, the patient stated that she had an itchy throat/tongue but no trouble breathing or injection site reaction. I gave patient a 12.5 mg dose of diphenhydramine oral solution at 12:05 PM as patient stated she is extremely sensitive to BENADRYL and I would monitor her in case we needed to administer more. At 12:10 PM, the patient stated that she was not feeling any worse and was having no issues breathing or talking. She still had some itchiness/tickling in the back of her throat but airway was ok. At 12:15 PM, patient continued to improve and still had no issues breathing or swelling of throat or tongue. Throat was slightly itchy, but no worsening of symptoms reported. I sat with patient and husband from approximately 12:20 PM to 12:35 PM to continue to monitor situation and patient continued to improve with no worsening, but improvement in symptoms. At 12:35 PM, patient felt better and safe to go home with husband. I counseled both husband and patient to look out for signs/symptoms of anaphylactic reactions and to go to hospital if trouble breathing or severe swelling occurred. I called patient at home at 4:11 PM and verified that she is doing better and feels like her normal self with no further adverse reactions to report.