chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Known allergies: Biaxin", notes: Known allergies: Biaxin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment of Paxlovid started on 16Feb2023 and stopped on 20Feb2023.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, covid-19 and the use of suspect product cannot be fully excluded.
Information has been received from a physician concerning an 18 year old female with allergy induced asthma and allergic to sulpha who on 12-AUG-2009 was vaccinated with second dose of VARIVAX (Merck) (booster) (lot # not reported) intramuscularly. On the same day on 12-AUG-2009 she received third dose of GARDASIL (MSD) (lot #, route and site not reported). Concomitant therapy included meningococcal vaccine (unspecified) administered on 12-AUG-2009. After getting the vaccine she experienced an injection site reaction. The arm swelled up and became warm and red. The patient did not seek medical attention. At the time on the report on 12-AUG-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow-up information was received from a physician, who reported that the female student with allergies to sulfa and AUGMENTIN received the second dose of VARIVAX (Merck) subcutaneously into right deltoid. On 12-AUG-2009, the patient developed swollen, red, 1/2 dollar size reaction and itchy. Subsequently the patient recovered. No further information is available.
Patient received a 12+ adult Pfizer COVID-19 vaccine dose instead of the authorized for his age 5-11 years Pfizer COVID-19 vaccine dose.  Parent notified via letter on 3/15/2023.
11 hours after injection had chills, and  headache. Day 3  chills and headache gone but arm itching, swelling, and red
10 min p/immunization given, bright red apapular rash to lt upper arm; DPH 12.5 mg PO given per order;
From initial information received on 11/03/03 from the patient regarding and adverse event occurring in the USA, it was reported that the 71 year old female patient received a dose of Fluzone SV '2003-'2004 USP, lot number not reported, administered intramuscularly in the left deltoid and a dose of Pneumovax administered in the right are ( lot number and route of administration not reported), on 11/28/03 at approximately 9:00 AM. Two hours later, the patient developed itching throughout her body, but denied rash or hives. She was also afraid that she "wasn't going to be able to take another breath" and developed respiratory symptoms such as nasal congestion and watering eyes. The patient also felt weak and lousy. She still complains of symptoms and has not recovered. On 12/09/03 the lot number for the product was provided via e-mail. The lot number for Fluzone SV '2003-'2004 USP was U1133AA and for Pneumovax 0986N. No other information was provided at this time.
Information has been received from a physician concerning a 12 month old female who in October 2002, December 2002 and 6/12/03 was vaccinated with Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. The physician reported that the patient subsequently developed a 1.5cm induration on her thigh after being vaccinated with the second dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. After several months, the induration did not resolve and the patient was referred to a surgeon who removed the induration. On 6/12/03, after receiving her third dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant, the patient developed a 1x1 inch induration that was slightly warm to the touch. The patient was afebrile and there was no pus or infection noted. The patient was seen by the physician and was treated with an unspecified non-steroidal, diphenhydramine HCl and local measures. At the time of this report, the patient's induration had not resolved. Upon internal review, 1.5cm induration was considered to be an other important medical event (OMIC). Additional information has been requested.
she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either; her back was extremely painful and the pain radiated into right arm; right arm was extremely painful and she couldn't move it either; She had to stay in bed.; her first two Covid vaccines were the J&J; injection it was a little sore for a couple of days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), on 10May2022 as dose 3 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson and johnson covid vaccine (DOSE 1, SINGLE, The first two Covid shots were Johnson and Johnson), for COVID-19 Immunization; Johnson and johnson covid vaccine (DOSE 2, SINGLE, The first two Covid shots were Johnson and Johnson), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 10May2022, outcome "unknown", described as "her first two Covid vaccines were the J&J"; BEDRIDDEN (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "She had to stay in bed."; BACK PAIN (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "her back was extremely painful and the pain radiated into right arm"; PAIN IN EXTREMITY (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "right arm was extremely painful and she couldn't move it either"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 11May2022, outcome "recovered" (May2022), described as "she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either"; VACCINATION SITE PAIN (non-serious) with onset May2022, outcome "recovered" (May2022), described as "injection it was a little sore for a couple of days".  Additional information: Caller states her first two Covid vaccines were the J and J and then she got her first Pfizer Covid vaccine on 10May2022. The next morning, she couldn't move her left arm at all, across her back was extremely painful and the pain radiated into right arm. So, her right arm was also extremely painful and could not move this one either. She had to stay in bed. The day after that it was gone. On this injection it was a little sore for a couple of days but nothing like the last time. This report was not related to a study or programmer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306015 same patient, different dose/AE;
pink spot on arm - right arm; kind of lump - right arm; mild flu symptoms; nausea; no appetite; generally sick all over; Just don't feel great; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea) and DECREASED APPETITE (no appetite) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea), DECREASED APPETITE (no appetite), MALAISE (generally sick all over) and FEELING ABNORMAL (Just don't feel great). At the time of the report, INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea), DECREASED APPETITE (no appetite), MALAISE (generally sick all over) and FEELING ABNORMAL (Just don't feel great) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medication included one acetaminophen.
Shingles Injection site became extremely red, swolen, and feverish and, by Saturday, had expanded to cover from elbow to shoulder.  By Saturday, 12/21/13, I was also running a fever of over 100 degrees, with severe body aches.
Red flushing cheeks at time of shot; swollen glands in neck; extreme pain in front of neck; shortness of breath/painful breathing; burning lips; burning nose; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in left arm on 06Mar2021 at 00:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune diseases and allergies to sulfa drugs. The patient took unspecified medication within two weeks.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Mar2021, the patient experienced red flushing cheeks at time of shot, swollen glands in neck, extreme pain in front of neck, shortness of breath, painful breathing, burning nose and lips. The adverse events resulted in a doctor or other healthcare professional office or clinic visit, and an emergency room or a department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with BENADRYL and ant-inflammatory medications. The clinical outcome of the event red flushing cheeks at time of shot, swollen glands in neck, extreme pain in front of neck, shortness of breath, painful breathing, burning nose and lips was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itchy reaction and very minor bleeding at the same location after the first dose; Itchy reaction and very minor bleeding at the same location after the first dose; Constant minor headache; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 06Apr2021 15:00 (Batch/Lot Number: ER8729) as 1ST DOSE, SINGLE for COVID-19 immunization at the public health clinic/veterans administration facility.  Medical history included high blood pressure. Concomitant medication included fluocinolone acetonide (FLUOCINOLONE ACETONIDE) taken for an unspecified indication and therapy date. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. It was reported that the patient had itchy reaction and very minor bleeding at the same location after the first dose on 09Apr2021 and stopped after a day (10Apr2021). The patient also had constant minor headache on 09Apr2021 which disappeared after the second dose (on 04May2021). The patient did not receive any treatment for the events.
PMH of COPD on 3L NC baseline, pAF on eliquis, CVA, T2DM, OSA on CPAP, and HFpEF. To ER complaining of several days of worsening SOB. On EMS arrival, she was found to be profoundly hypoxic with sats of 48% The pt was found to have COVID, MSSA and klebs PNA, she was on appropriate abx,  had worsening AKI nephro was following.  pt rec'ed remdisivir, steroids, antibiotics. intubated on 2/6/22; The pt had a progressively worsening clinical course. Ultimately pt had cardiac arrest, and during ACLS the family told staff "let her go" -> pt was transitioned to end of life care.
Area of skin on left deltoid/injection site erythemic, warm and TTP. Size 4.5 x 8 cm. Ibuprofen 600 mg po TID, cool compresses f/u in 24 hrs scheduled.
Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the injection.  Since has had multiple issues and concerns, such as SOB, dizziness, joint and right arm pain, fatigue and nausea that started about an hour after receiving her vaccine. She said she has SOB at rest but with any type of exertion she is gasping for air. Rates her joint pain off the charts with walking and is bent over.
No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022).    No concomitant medication was reported.  Reportedly, the vaccine received date was 07-Jun-2022 and BUD date was 07-Jul-2022.  No treatment information was provided.
Patient describes being very fatigued and a low grade headache, patient also said he was advised that his body temperature is lower than normal
Acute pancreatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATITIS ACUTE (hospitalization, medically significant), outcome "unknown", described as "Acute pancreatitis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Toe pain; Breast pain; one eye will flash a little bit; Swollen lymph node; Pain in random places all over her body; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node), MYALGIA (Pain in random places all over her body), PAIN IN EXTREMITY (Toe pain), BREAST PAIN (Breast pain) and PHOTOPSIA (one eye will flash a little bit) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM (ATIVAN) and LORAZEPAM for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node), MYALGIA (Pain in random places all over her body), PAIN IN EXTREMITY (Toe pain), BREAST PAIN (Breast pain) and PHOTOPSIA (one eye will flash a little bit). At the time of the report, LYMPHADENOPATHY (Swollen lymph node), MYALGIA (Pain in random places all over her body), PAIN IN EXTREMITY (Toe pain), BREAST PAIN (Breast pain) and PHOTOPSIA (one eye will flash a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L013429, expiration date 21-JUL-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the reporter stated that the physician could not be contacted.
Patient in office today for third Gardasil states that she had "body tremors" for several days after 1st injection. Had he same after second injection but didn't last as long. Third dose held until verifies with MD.
This initial spontaneous case, was received from nurse on 10-Oct-2017, concerning a 55-year-old adult female patient. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: Apr-2018 route of administration: intramuscular, anatomical location: deltoid). On the same day, immediately after the vaccination, the patient experienced itching, hotness and redness at the injection site. The patient was treated with BENADRYL and applied the ice. On 06-Oct-2017, itching at injection site was resolved in 24 hours, hotness and redness at injection site were resolved in 72 hours (08-Oct-2017) of vaccination. The reporter assessed the report as non-serious. Significant case correction received 10-Oct-2017: duration for redness changed from 4 days to 3 days, during for itching was added. Follow up received on 21-Nov-2017: The gender of the patient (female) and stop date of the event itching at injection site (06-Oct-2017) were updated. The narrative was amended accordingly.
Burning, painful, unable to lift arm. Received injection on 10/4. Unable to lift arm on 10/5. Received treatment on 10/18.
Medication error: 0.5 dose of moderna was given to an immunocompromised PT who received J and J as their original series. PT was contacted and told to triple fluid intake. Pt voiced understanding.
Idiopathic Pulm fibrosis; Gi distention/loss of ability to eat; loss of ability to eat; Hbg from 11 to 8.9; dramatic drop in iron/ferritin; dramatic drop in iron/ferritin; auto-immune inflammatory response; auto-immune inflammatory response; hair loss; pale/pallor appearance; short of breath; This is a spontaneous report from a contactable nurse (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 23Feb2021 17:00 (Lot Number: EN8203), at the age of 73-years-old, as dose 2, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Medical history included Idiopathic thrombocytopenic purpura from 2003, lupus from 2004, hypertension from 2020. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported, and Multivits. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 28Jan2021 17:00 (Lot Number: EN6203), at the age of 73-years-old, as dose 1, single for covid-19 immunisation. The patient has known allergies to penicillin and  tetracycline. The patient reported having lupus and 3-4 months after last dose, in Jun2021 had an auto-immune inflammatory response, hair loss, pale/pallor appearance, short of breath. Later labs and tests showed in Aug2021 drop in hemoglobin (Hbg) from 11 to 8.9./ dramatic drop in iron/ferritin, gastrointestinal (GI) distention/loss of ability to eat, and computerized tomography (CT) scan showed new development of Idiopathic Pulmonary fibrosis. The events were reported as non serious. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit. Treatment was received for the events. And new consults with primary, Hematology, GI (gastrointestinal), Rheumatology was required. The patient was recovering from the events.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported events cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Approximately 7 days after the injection, my upper arm became itchy,  swollen, red, and warm to the touch.  I went to Urgent Care and they said it was a reaction to the vaccine and they gave me a prescription for a steroid cream to put on the rash.  It measures 4 centimeters by 8 centimeters as of now.  The doctor recommended taking Benadryl before the second vaccine.
Initial report was received on 17 September 2009 from a health care professional. A 53-year-old female patient had received an intramuscular left deltoid injection of FLUZONE and one hour later, she developed a metallic taste in her mouth with increased salivation. She had no concurrent illnesses or pre-existing medical conditions and she had not been taking any concomitant medications at the time of vaccination. The reporter also noted that the patient had not received any testing or contrast media, and that she had not experienced these symptoms before. At the time of the report, the patient had not recovered. Documents held by sender: None.
That night, I started experiencing intense headaches. The headaches worsened over the night and morning. In the morning, I got dizzy and fell. I completely blacked out and I bashed my face into the night stand. I also cut my nose. I went to the ER and received stitches.
The second dose of Pediatric Pfizer vaccine was given 7 days earlier (February 3, 2022) than should have been based on the date of the first dose (January 20th, 2022)