chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 4-year-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 14-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1610USA004609: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Tightening and pain in esophagus for 6 weeks.  Lost 12-15 pounds due to lack of appetite and pain.
Pt fainted 20 min after injection of GARDASIL, FLUZONE and LA BICILLIN injections. Hit head. No LOC. No sequelae noted - Did well after TX.
Can it cause rash on back; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked if shingles vaccine could cause rash on back. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
10 y/o female who had Hep A shot and w/i hours developed itchiness in arms & legs, accompanied by fever (102 degrees F) & sore throat. Also developed some pain (R) hip. No redness or increased heat & subsequently had desquamation in sheets on buttocks.
Arm soreness - pain on the sides of the arm where I had the injection that lasted about 24 hours. I had loose stools - 29th of April - four times in  six hours - 12 noon to 6 pm.  Right after midnight, I had the chills -  it was the night right after the loose stools. My temperature - 99.1. I had pain in my joints and body aches. Chills lasted two to three hours. I took Tylenol to help with this so I could sleep. In the morning, I was having joint pain. I took another Tylenol and then I got better.  I told my PCP - had a virtual visit  - and they told to have a COVID test because the day before I was at the COVID clinic giving vaccines. I had a COVID test done on Friday on April 30th. I had runny nose - later in the afternoon (30th). It was just dripping - don't know if it was from seasonal allergies or not. I  took some natural allergy medicine (BORON). My runny nose stopped the following day.
right hand swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (right hand swelling) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-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 PERIPHERAL SWELLING (right hand swelling). On 19-Jan-2021, PERIPHERAL SWELLING (right hand swelling) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Patient is stating that she was fine but 3 days post administration, she started getting injection site rash, redness and mild swelling. The rash is getting worse (spreading) and feels hot to touch 5 days post administration. Today is 6th day and pt came in complaining today.
8-11-15 4:22 pm KINRIX Dtap IPV Lot 3N7Y7 expiration 05/27/2017 manufacturer GlaxoSmithKline given (R) thigh IM. Pt was on antibiotic for ear infection at time of injection. Pt waited 10 minutes with no reaction. 8-13-15 4:40 pm pt came in with localized reaction at the injection site. Redness, raised area, warm to touch blotchy rash.
Patient received HPV #2 at 10:05. One to two minutes after it was given, she felt dizzy, and had headache. She was placed on Trendelenburg position and slowly recovered. BP-HR was check every 5 minutes and were normal; she went home after 20 minutes and was well.
Severe muscle spasms/pain in low back and under arm area. Pain and spasms have continued since day after vaccination.
Numbness and tingling on left side of lips and left cheek; Numbness and tingling on left side of lips and left cheek; Numbness and tingling on left side of lips and left cheek; Numbness and tingling on left side of lips and left cheek; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 23:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included epstein-barr, melanoma and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received ciprofloxacin (CIPRO) on an unknown date for unknown indication and experienced drug allergy.  On an unknown date in 2021, the patient experienced numbness and tingling on left side of lips and left cheek which lasted for 10 minutes. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events numbness and tingling on left side of lips and left cheek were resolved on an unknown date in 2021, after the duration of 10 minutes.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
CLIENT DESCRIBES RAISED RASH AND ITCHING OVER HER BODY ABOUT 72 HOURS POST VACCINE. STATES SHE ALSO HAD FEVER. CLIENT WAS SEEN ON 4/11/06. sHE HAD HX OF SKIN RASHES UNDER TREATMENT, NEW RAISED "HIVE LIKE" AREAS WERE NOTED ON ABDOMEN AND LEGS, AS WELL AS SCALP, ASSOCIATED WITH ITCHING, SHE WAS KEPT AWAKE AT NIGHT AND STAYED HOME FROM SCHOOL FOR 3 DAYS
before the pandemic and not being able to receive dose two; This case was reported by a consumer via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of herpes zoster (received first dose of Shingrix in October 2019 and experienced shingles, for tolerance of 1st dose refer case US2021202974). Concurrent medical conditions included tingling, scar and shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the 1st dose before the pandemic and did not receive the dose two till the time of reporting. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202974:same reporter, same patient
This spontaneous report as received from a registered nurse refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
Bleed after going through menopause; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 31Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous immunization series complete, MANUFACTURER UNKNOWN), administration date: 2021, for COVID-19 Immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Bleed after going through menopause".  Additional information: A 67-year-old female patient stated that she had the Pfizer COVID-19 vaccines last year and the Pfizer  COVID-19 booster on 31Oct2021. The patient was asking if it was a normal side effect for a woman to bleed after going through menopause after having the Pfizer COVID-19 vaccines, and could it be the vaccines that caused it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
little bit of soreness at the injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 026A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Chronic lung disease and Polyneuropathy.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, 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 experienced INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (Fatigue). At the time of the report, INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient had taken 6 doses of the Moderna COVID-19 vaccine. Tolerated all shots well and not gotten sick, the patient had a little bit of soreness at the injection site and fatigue with all of the doses. This was similar compared to his experience with any other shots. Lasted 1.5 days before resolving with each dose. The patient was very thankful for the Moderna COVID-19 vaccines.  Other doses included-Dose 3: 09-Nov-2021, lot number 004F21N; Dose 4: 03-Jun-2022, lot number 05A22A; Dose 5: 28-Nov-2022, lot number 016H22A and Last dose unknown date or lot number but received it from a pharmacy.   This case was linked to MOD-2023-749422 (Patient Link).
Patient complained of itchiness on neck and arms.  PHN gave 25 mg benadryl PO.  Sent home in stable condition.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Vomiting-Severe, Additional Details: Within 24 hours she started to exhibit severe vertigo, and would have projectile vomiting upon sudden movements of her head.  She had covid back in January.  Symptoms started to subside around 8/16.
vaccine brand=Pfizer / BioNTech/vaccine brand other=Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06May2023 at 16:00 as dose 4 (booster), single (Lot number: GJ326P) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Dec2021 as dose 3 (booster), single (Lot number: 041J21A), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney stone", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: MACUHEALTH, start date: 01Jan2022, stop date: 16Sep2023; LIFEPAK NANO, start date: 01Jan2022, stop date: 16Sep2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand=Pfizer / BioNTech/vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Known allergies was reported as NKMA. Stage 0 melanoma removed in Feb2023.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2, bnt162b2 omi ba.4-5  in this patient cannot be completely excluded.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Redness and swelling of left upper arm where injection was given. Appeared like cellulitis.
"rash appeared 11JUL97 w/dec appetite & fluids;rash was macular, red, blanching, vesicular across head, torso, upper extremities & upper portion of lower extremities;dx by clinic chickenpox;12JUL rash receded w/o blisters w/dx: rubella p/MM
Information has been received from a Doctor of Pharmacy concerning a 51 year old male patient with a history of a previous outbreak in March 2001 at a different location and "not known" drug allergies or reactions, who on 03-DEC-2010, was vaccinated subcutaneously in the left deltoid with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #669408/1384Z, expiration date: 12-JAN-2012). Concomitant therapy included simvastatin (manufacturer unknown). Pharmacist reported that on 15-FEB-2011 the patient developed a single lesion in the center of his back and nerve pain in the area after administration of a dose of ZOSTAVAX (Merck). It was reported that the patient was diagnosed with shingles. Patient was treated with VALTREX and VICODIN. At the time of the report patient was recovering. Patient sought unspecified medical attention. Follow up information has been received from a Doctor of Pharmacy. It was reported that the patient, who "10 years ago" (in March 2001), experienced shingles outbreak on shoulder area. It was reported that on, 03-DEC-2010 morning, the patient was vaccinated with a first dose of ZOSTAVAX (Merck). The pharmacist reported that on 15-FEB-2011 the patient had a single "pustule" in the middle of the back and pain (nerve), similar to the shingles outbreak he experienced 10 years ago. No laboratory diagnostic tests were performed to the patient. The patient was seen by the primary care physician who prescribed him valacyclovir 1gr three times a day (TID) for 7 days and hydrocodone (+) acetaminophen 5-500 mg as required/necessary (PRN) for pain. At the time of the report patient had recovered (date unspecified). No further information is available.
Heavy bleeding during menstrual cycle that persisted for several months.  Ended up with a hysterectomy.
Patient received pediatric dose of Pfizer Covid-19 vaccine instead of adult Comirnaty. Was first dose out of box and error was found when getting vaccine for next patient. Patient notified and reported no side effects. Most likely effect is insufficient protection from vaccine. Currently evaluating course of action in terms of timing for patient to receive correct vaccine.
5ml syringes that had been provided by a Health Authority were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/16/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
Extreme fatigue in the evening; next morning severe muscle pain throughout the whole body; shivering; headache; fever; stomach pain; nausea; extreme fatigue; goose egg sized swelling at injection site
Only a sore arm the day of and after; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021 US085199_NS (Novartis Pharmaceuticals Corporation).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 65 years 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Only a sore arm the day of and after". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given a dose of 0.2 ml out of a vial that had not been diluted
#3 PFIZER COVID VACCINE GIVEN 5/11/22, LOT #FK9893; pt to ED via EMS with nausea and vomiting, febrile; positive test for COVID; COVID pneumonia; septic; given ABX, steroids, O2 supplementation; Blood cultures positive for staph epidermis; leukocytosis; iron deficiency anemia; hypernatremia; poor oral intake; PEG tube; pt's condition declined; he passed away in the hospital, was found unresponsive, without pulse or respirations, no response to tactile stimuli
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) for the permanent prevention of shingles and zoster related injuries. Later in 2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
pt recv vax 19JAN98 & a couple of days p/vax pt devel a rash that looks like ring worm;the rash was located on thigh, labia & rt buttock;
Took a at home Covid test that came back positive.; Took a at home Covid test that came back positive.; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 38-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "adhd" (unspecified if ongoing); "was in close contact with son that tested positive Saturday for Covid" (unspecified if ongoing). 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 "Took a at home Covid test that came back positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: She was in close contact with son that tested positive Saturday for Covid. Sunday evening she felt exhausted. Monday morning she woke up extremely exhausted, body aches, chills, cough, severe headache, severe sinus pressure. Took a at home Covid test that came back positive.Symptoms started 1.5 days after son started showing symptoms  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 known drug safety profile, there is reasonable possibility of causal association between the events Drug Ineffective and COVID-19  and the suspect drug BNT162b2.