chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clarified that the caller had 4 shots before she got Covid the first time; Clarified that the caller had 4 shots before she got Covid the first time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: She is also immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Clarified that the caller had 4 shots before she got Covid the first time".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
30MARCH99 to ER w/ lt leg sided chest pain,high blood pressure;pain was worse the night before ER visit, took NTG;tx nitro drip,O2 & atenolol;Dx unstable angina
Patient is 17 yrs 2 months and the Moderna Vaccine has not gotten official approval for those under 18 at this time.   Pt did not report any physical symptoms at time of vaccination and none reported back to this writer at this time.
patients of the pharmacy received only the diluent portion of Menveo; patients of the pharmacy received only the diluent portion of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: patients of the pharmacy received only the diluent portion of Menveo) and inappropriate preparation of medication (Verbatim: patients of the pharmacy received only the diluent portion of Menveo). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date 21 Jul 2023 The pharmacist called to inform that one of the patients of the pharmacy received only the diluent portion of Menveo. At the moment of the reporting, the pharmacist had not determined who was the patient that received only the liquid portion. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. The reporter wasn't able to provide any information on the patient. The patients of the pharmacy received only the diluent portion of Menveo, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
No additional adverse event; Pediatric patient was inadvertently administered adult dose of VAQTA; Pediatric patient was inadvertently administered adult dose of VAQTA; This spontaneous report was received from a registered nurse referring to a 4-year-old patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  On 30-AUG-2021, the pediatric patient was inadvertently vaccinated with an adult dose (product administered to patient of inappropriate age and incorrect dose administered) of hepatitis a vaccine, inactivated(VAQTA), 1 milliliter for prophylaxis (route of administration, lot number, and expiration date were not reported).  No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000237:
Pt developed swelling, redness, pain, stiffness and heat at the left deltoid.
Arm started to feel more tender; Arm became swollen and red; A bump formed near the injection site; Arm became swollen and red; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm started to feel more tender, arm became swollen and red, a bump formed near the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events arm started to feel more tender, arm became swollen and red, a bump formed near the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm started to feel more tender, arm became swollen and red, a bump formed near the injection site was unknown.
Child began itching on 8/6/07 - Mother noticed hive type rash on 8/7/07. Denies trouble breathing. Rash spreading per mother. Rash does not look like chicken pox. Denies any other symptoms of illness. Referred pt to MD/ER for evaluation.
Patient reports itching that sent her to ER on 10/27/2007. She reports that they treated her for an allergic reaction, giving her an IV and a script for an oral medication. Later went to her primary medical provider who gave diagnoses of Shingles. Patient states that the "rash" started as pimples on skin, beginning on her neck and later spreading to her hips. Medical provider also began testing for other symptoms:based on a recent kidney scan, patient has just been diagnosed with cancer in right kidney. Further medical appointments now scheduled for patient. Patient relates following symptoms due to Shingles: open sores on buttocks, pain, and diarrhea. Treatment consists of Benedryl, soda baths and a "white pill". Patient also stated that she now had chicken pox on neck and buttocks. A call was placed to her health care provider to confirm chickenpox (a reportable disease). Provider confirmed Shingles but denied that patient had chickenpox. Provider states that patient does now have diagnoses of cancer but that she did not have that diagnoses at time of vaccination.
4.2 x 4.2 cm wheal with redness, BENADRYL q 6 hrs prn, monitoring.
No additional AE information reported; the patient received her second shot of GARDASIL 9 2 years later on 14-MAY-2021; This spontaneous report was received from a consumer referring to a currently 18-years-old female patient. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 06-SEP-2019, at the age of 16-years-old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location, lot number and expiration date were not reported). The patient's doctor refused to give the patient her second shot 2 months later, because it was during flu season. Then in March she didn't get her second shot because of the pandemic. Therefore the patient received her second shot of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location, lot number and expiration date were not reported) 2 years later on 14-MAY-2021.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 18-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular, dose not reported). On an unspecified date the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
splitting headache; Migraine; temperature; decrease the appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, I had the Moderna (Unspecified vaccine) the first three were Moderna this one Pfizer), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 2, I had the Moderna (Unspecified vaccine) the first three were Moderna this one Pfizer), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 3, I had the Moderna (Unspecified vaccine) the first three were Moderna this one Pfizer), for COVID-19 Immunization.  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "splitting headache"; MIGRAINE (non-serious), outcome "unknown"; BODY TEMPERATURE ABNORMAL (non-serious), outcome "unknown", described as "temperature"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decrease the appetite". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There is something wrong with that patient have like splitting headache, getting Migraine, temperature, decrease the appetite. patient didn't get this with Moderna. Reason for no lot number: of Unspecified Vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of Unspecified Vaccine: Unknown. Consumer stated,  had the vaccine, the Pfizer the newest one on Thursday. patient had the Moderna the first three were Moderna this one Pfizer. There is something wrong with that patient have like splitting headache, getting Migraine, temperature, decrease the appetite. patient didn't get this with Moderna. Patient meant what's going on. Further probing could not be initiated as consumer hung up abruptly. Hence, product details (LOT, expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received concerning a pt who was vaccinated 07/96 with varicella vaccine. On 07/11/2000 the pt was seen in the physician's office with greater than 25 lesions and was diagnosed with chickenpox. It was noted that the pt only complained of itching and was afebrile. He was treated with Atarax and acyclovir. On 07/26/2000 the pt recovered.
w/in 15min of vax pt devel redness & pain @ inj site;pt also cried for several hr;tx w/Advil, APAP, & ice packs & was recovered @ the date of this report;MD noted that this rxn was more severe than following prev doses of vax
temperature excursion; Subcutaneous injection formulation administered by other route; No other AE; This spontaneous report was received from a nurse prescriber and refers to a 4 year old male patient.  No concomitant medications, concurrent conditions, medical history, drug allergies and reactions were reported.  On 10-MAR-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # T021640, upon internal review determined to be valid, expiration date 21-DEC-2021 (also reported as 12-DEC-2021 and 20-DEC-2021), intramuscularly (incorrect route of administration) in the right thigh for prophylaxis. The vaccine underwent temperature excursion of maximal 6.2F for 8 minutes (started at 1:41 pm and stopped at 1:49 pm) on 08-MAR-2021. Digital data logger was involved. Previous temperature excursion was reported. The patient experienced no adverse event. No product quality complaint was reported. After the administration, the nurse was placed on probation and completed mandatory training. Temperature/vaccine stability was determined and it was reported that the use of vaccine was ultimately supported.
Booster dose of Moderna COVID-19 Vaccine instead to 1st dose of Pfizer Vaccine to a 13-year-old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose of Moderna COVID-19 Vaccine instead to 1st dose of Pfizer Vaccine to a 13-year-old patient) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose of Moderna COVID-19 Vaccine instead to 1st dose of Pfizer Vaccine to a 13-year-old patient). On 05-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose of Moderna COVID-19 Vaccine instead to 1st dose of Pfizer Vaccine to a 13-year-old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient had not experienced any symptoms, so no treatment was given.
On 6/5/11 mom stated leg (right) was red & swollen around vaccine site. At office visit 6/6/11 child was given BENADRYL & TYLENOL.
Differential Diagnosis: hypoglycemic event; chest tightness; lightheadedness; This is a spontaneous report from a non-contactable other health care professional (patient).   A 77-year-old non pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration on an unspecified date at the age of 77-year-old as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. After the injection, 15 minute later, the patient began to experience chest tightness and lightheadedness. She denied rash, glossal tightness or increased work of breathing This provider was notified of patient reaction and was then assessed in the emergency bay area. Treatment provided in response to the event was oxygen, blood glucose and Vital Sign monitoring, snack. In response to the treatment, complete resolution of symptoms Patient discharge with stable to go home and follow up with primary care physician. Patient's differential diagnosis was hypoglycemic event. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
barely got out of bed; ached very bad; terrible headache; light headiness; felt like bad case of the flu; fever of 100; rash at injection site; warm and uncomfortable at injection site; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of bedridden in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort. On an unknown date, the outcome of the bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort were recovered/resolved.   It was unknown if the reporter considered the bedridden, pain, headache, light headedness, influenza-like symptoms, fever, injection site rash, injection site warmth and injection site discomfort to be related to Shingrix.  Additional details were reported as follows: The age at the vaccination was not reported. The patient received shingrix vaccine and for the first two days patient could barely get out of bed, she ached very badly, had a terrible headache with light headiness, felt like she had a bad case of the flu,  a fever of 100 and a rash at the injection site which was warm and uncomfortable.  On the third day the symptoms began to resolve. The patient medical doctor recommended that she get her second shot. Reporter consented to follow up.
7-month-old patient came into clinic with parents seeking his 6 months follow up vaccines: Hep B, Dtap, Rotavirus, Hib, IPV, and PCV 13. Prior to patient coming into the room all three nurses began to review the immunization record in system. Nurse #1 was the administering nurse, Nurse #2 and Nurse #3 noticed that the 3rd dose of rotavirus was needed. Nurse #1 asked for reassurance if rotavirus was always given as 3 doses, even if the stocked rotavirus vaccine, monovalent (Rotarix) was only 2 doses, and was reassured by nursing staff that rotavirus is always given as 3 doses. Based on prior knowledge Nurse #1 recalled that the stocked vaccine (Rotarix) is only to be given for 2 doses. However, listed under the Due Record included rotavirus as a third dose to be given. Prior administrations included 1 dose of Rotavirus, monovalent (Rotarix) on 2/2/2022 and 1 dose of Rotavirus, pentavalent (RotaTeq) on 6/13/2022. Nurse #1 prepared and gave the 3rd dose of rotarix to patient. Nurse #2 and Nurse #3 simultaneously looked for dosage on CDC website and pink book as reassurance, however realized that (Rotarix) is indeed only to be given for 2 doses. Prior administrations had been entered incorrectly on system, and therefore prompted nursing staff to administer rotarix for a third time. After the correction had been made on the patient's record as 2 doses of Rotavirus, monovalent (Rotarix), a third dose was no longer indicated. Nurse #1 and Nurse #2 explained the incident of dosage error, possible adverse reaction, and emergency services if needed to patient's parent. Patient's parents given opportunity to ask questions and acknowledged. No further questions asked and reassured that follow up contact would be made within two days to assess if the infant had no adverse reactions.
arm pain down to fingertips started 3/26/2021. weakness in arm and muscle pain. on 3/26/2021 running fever of 102 with headache, upset stomach, chills,  severe hot flashes, sweating through bedding.  symptom's persisted until 3/28/2021
Patient received influenza vaccine at approximately 1:00pm 09/26/2005. She called the clinic 24 hrs later to report a rash on the trunk of her body, under breast and on belly. Rash does not itch. No other symptoms reported. Called 09/29/2005 rash gone.
Low blood pressure, nausea, sweat, shaking chills, blurry vision . That symptoms occurs one month after my second doses .
severe pain all over my body.. almost unbearable..lasting severely for at least 6 hours., shivering and shaking, and nausea.  Then, began to lessen after that, taking 2 full days to recover to somewhat normal.
vasovagal syncope within 12 hours of vaccine, localized skin irritation, induration at site of vaccine, resolving symptoms after 2 days
This spontaneous report was received from a physician via a company representative and refers to a 19 year old male patient. No information on his concurrent conditions was reported. The patient's medical history included scoliosis and back pain. The patient received the full three dose regimen of GARDASIL (exact doses, route of administration, lot# and expiry dates were not reported) for prophylaxis on the following dates: 09-MAY-2014, 11-JUL-2014, and 02-JAN-2015. The patient was unaware if he had completed GARDASIL series and on 28-NOV-2017, he was vaccinated with a dose of GARDASIL 9 lot # N022727, expiry date 12-06-2020 (exact dose and route of administration were not reported) for human papilloma virus (HPV). On the next day physician became aware that patient had previously completed series of GARDASIL on dates mentioned above. The patient also received the TRUMENBA, lot# R56659, expiry date 31-JAN-2019 on the same day. Concomitant therapies included ALEVE taken as needed. In the evening of 28-NOV-2017, the patient experienced back pain. On a scale of 1 to 10, the pain was reported by the patient as a "7". The patient had difficulty sleeping and woke up with severe joint and back pain. The patient sought medical attention. The physician advised patient to take TYLENOL or ibuprofen to pain control and ordered blood work (complete blood count and Thyroid-Stimulating Hormone (TSH)) on 29-NOV-2017. The outcome of the events was reported as not recovered. The causality assessment between all events and GARDASIL 9 and GARDASIL was not reported. The reporter determinated that severe joint and back pain level was causing significant disability.
Pt. reports that she awake yesterday AM with upper rt. arm sore, slightly swollen and tight with knot @ injection site and hot to touch. Denies any difficulty breathing N/V or diarrhea. No MD or ER visit. Pt. states doing much better today.
next day I had fever 101, fever, diarreahhe , sore arm, coughing. 2 days , headache
Irritability. Vomiting. Diarrhea. Began a few hours after Hep B vaccine.
This spontaneous report was received from an administrator and refers to two patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unspecified date, the patients were vaccinated with doses of improperly stored GARDASIL 9, lot # L004741, expiration date 04-MAR-2017 (strength, dose, frequency and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.