chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients.) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 15JUL2022 and administration of vaccine on 18AUG2022). Concomitant medications were not reported. They administered Moderna Covid-19 vaccine from the refrigerator past its 30 use by date to 3 patients. The total number of doses were 3 doses. The vial did not undergo any temperature excursions. They were unsure of which injection in the series this was for the patient. No other adverse reactions reported. Treatment medications were not reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 21-FEB-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Site: Pain at Injection Site-Medium, Additional Details: Patient does not have full mobility of left arm. Cannot lift above head
URI, bronchitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation, COVID-19, Other viral illness
Aunt stated client developed a fever, nausea, redness and swelling at the injection site on Saturday morning.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L038501 with expired date 16-AUG-2018, dose and route were unknown). No concomitant therapy was reported. The reporter stated that the temperature excursion of the vaccine was 10.3 degrees Celsius for 30 minutes. No adverse effect was reported. There was several reports received from the same reporter. Additional information has been requested.
Within a day of receiving 1st HPV vaccine, he began to have symptoms of gnawing abdominal pain with nausea and vomiting. This has become more frequent since 2nd HPV dose (10/26/2016). CBC, CMP, H. Pylori have been negative. Have tried ZANTAC to diet modification without help.
Aside from normal tenderness at the injection site which I had after the first dose, the most adverse reaction was fatigue.  Fatigue set in about 12 hours after the injection.  I did not have nay trouble sleeping but I was still very tired the next morning.  I did not experience any fatigue after Dose 1.
Pain injection site/pain at the injection site; Headache; Muscle pain; Chills; Joint pain; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. This patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: unknown) via an unspecified route of administration, as a single dose on 21Jan2021 for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported receiving the COVID-19 vaccine with their husband "yesterday" (as of 22Jan2021). The reporter stated they experienced all of the reactions listed on "the page" and questioned if they should take anything. The patient stated nothing severe "that all of the one that have listed " like pain at the injection site, headache, muscle pain, chills, joint pain "that kind of things" (Jan2021). The patient wanted to know how long it should last and if there was anything they could take to make themselves more comfortable. The clinical outcomes of pain injection site/pain at the injection site, headache, muscle pain, chills, and joint pain were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093513 same drug, same event, different patient
arm pain for 2-3days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arm pain for 2-3days) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain for 2-3days). At the time of the report, PAIN IN EXTREMITY (arm pain for 2-3days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2022-442844 (Patient Link).
Woke up early (8AM) not feeling well had a headache felt nauseous. Felt really bad and dizzy unable to take her medication. I even tried to eat salt crackers and kept vomiting. Couldn't keep down the simplest things like sips of water. Contacted her doctor to get her some anti-nausea medication (Zofran). Took the medication around 2PM and it had zero effects. The nurse called back around 4 and she wasn't doing any better the nurse then instructed us to go to the ER. Went to the ER and was admitted due to dehydration. A bad episode of rheumatoid arthritis was triggered which lasted for a couple of weeks. Also developed vertigo which caused her to go through physical therapy for 3 weeks to a month. Iron levels were also I low so she was prescribed iron medication as well.
Unconsolable crying approximately 8 hours after vaccine administration lasting around 4 hours. Was seen at office where patient had lab work, CXR all being wnl.
Patient presented to appt with PCP.  Patient requested to receive Shingrix vaccine.  Patient is only 46 years old and not recommended until age 50.  Patient was given vaccine when nurse got approval from PCP. No adverse reactions noted.
Headache, Fever, Chills, fatigue, pain at the injection site Narrative:
11/15 - body aches starting at 6 pm 11/16 body ache, head ache, fever, weakness all day 11/17 slight body ache until 2 pm. then body aches, head ache, fever, weakness 11/18 body ache, head ache, weakness
Large local reaction at vaccine site. 6.5 x 7 cm erythema and swelling on left upper arm.
A few inches below the shot my arm turned red, swelled up, and was hard. It was like that for 8 days. The muscle in my arm has been sore since.
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient mentioned that she does not like vaccines.  I gave the shot and had patient sit there to be monitored.  Her mother was there as well. Patient experienced light-headedness.  As she was going forward to put her head between her legs, she fell all the way forward, hit her head on ground and received a wound to the left eye brow area.  Called 911 and patient was taken to the hospital by ambulance.
pt became cyanotic & shaking like was very cold & having rapid resp;T103;temp down giving APAP;T101.On 10/26/99,pt exp generalized seizure w/ loss of consciousness. 10/28/99:Pt admitted to hosp.
Palpitations; Tachycardia; Increased heart rate; the side effects was worst with the booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 52 years, in left deltoid for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (the second shot I got on 29Jan2021,Single, Lot: EL3247), administration date: 29Jan2021, for Covid-19 Immunization, reaction(s): "Palpitations", "Tachycardia", "Increased heart rate"; Covid-19 vaccine (Dose 1, Single, manufacturer Unknown), for Covid-19 Immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown"; TACHYCARDIA (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Increased heart rate"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "the side effects was worst with the booster". The events "palpitations", "tachycardia", "increased heart rate" and "the side effects was worst with the booster" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of palpitations, tachycardia, heart rate increased, condition aggravated.  Additional information: It was reported that Tachycardia; Increased heart rate, lasted for a month after the vaccine and the side effects was worst with the booster then with the second shot. Doctor stated that No treatment was taken because nothing was diagnosed. So he did go to the doctor and did not go through testing but this was not in the past two weeks." Age at time of vaccination was reported as 52 and she was 53 and by the time of vaccination I was 52." Lot#: Doctor stated the lot number one given on 29Jan was EL3247 and the one given in Nov was FH8020."  No follow-up attempts are required. No further information is expected.
sore under left arm - lymph nodes; Sore neck; stiff neck; sore arm; dose number=3; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FF8839), intramuscular, administered in Arm Left on 30Sep2021 18:30 (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included gastro-oesophageal reflux disease and arthritis. Concomitant medications/other medications in two weeks included pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken for gastro-oesophageal reflux disease and ibuprofen (IBUPROFEN) taken for arthritis from an unspecified start date and ongoing. No known allergies. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318), intramuscular, administered in Arm Left on 09Feb2021 13:00 as dose 1, single for COVID-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FL3302), intramuscular, administered in Arm Left on 09Mar2021 13:00 as dose 2, single for COVID-19 immunization. No other prior vaccinations (within 4 weeks). No Covid prior to the vaccination. No Covid tested post vaccination. On 30Sep2021 18:30, the patient received dose number=3 (booster). On 01Oct2021, the patient experienced sore arm. On 02Oct2021, the patient had stiff neck and sore neck. On 03Oct2021, the patient had sore under left arm - lymph nodes lasting 2-days. No treatment was given for adverse events. The events were reported as non-serious.The outcome of the event sore neck was unknown. The outcome of the events sore arm, stiff neck and sore under left arm - lymph nodes was recovered on an unknown date in 2021.  Follow-up attempts were completed. No further information was expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In September 2016, a healthcare provider at a medical center administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 24-DEC-2016, the patient was treated by a healthcare provider at the same medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, 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; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Information has been received from a physician via company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 28-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 416, 24, 168, 336, 1172, and 80 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius) and -3 . The highest recorded temperatures were 49, 47, 59, and 48. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX 23 on 30-AUG-2012. Lot # was reported as 0493AE, expiration date: 08-DEC-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 8-0 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reports received from the same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008603, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614 Additional information has been requested.
Information had been received on 17-NOV-2015 from an 88 year old male with history of high blood pressure, bladder control, fluid retention and thyroid with allergies to neomycin, penicillin, sulfa, common aspirin, all inflammatory drugs for arthritis, statin drugs, ZETA, nonsteroidal anti-inflammatory drugs (NSAIDS), niacin, amiloride hydrochlorothiazide, ibuprofen, CELEBREX and cefpodoxime. Patient was treated with ZOSTAVAX one time vaccine in the right hip "7 years ago" (dose and date of vaccination were not provided). Concomitant medications included metoprolol, warfarin, OXYBUTIN, fish oil and LASIX (dates of use, dose and indication not reported). Patient reported he had become "paralyzed in both legs" (onset not reported). Patient stated that four days after getting the vaccine he developed the shingles (date not reported). He said that over the next three months, he continued to lose his balance and "became unable to walk" (onset not reported). Patient also stated that he had outbreaks of "hives" and had been diagnosed with vitamin deficiencies after getting ZOSTAVAX (onset not reported). Patient sought medical treatment and underwent blood tests (dates and results not provided). Treatment included a series of steroids and a medicated salve. Outcome of events was not reported. Patient was currently proceeding with legal action to recover medical costs. Patient declined to be transferred with the legal issue. No other information was provided for documentation. Upon internal review, paralyzed in both legs was determined to be medically significant. Additional information has been requested.
Itchy at injection site; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (rash at injection site). On 03-Mar-2021, VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (rash at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Took 2 benedryl prior to vaccine. Vaccine rec'd at 4:30 pm woke up at 2 am with hives and severe itching on arms, throat and upper torso along with scratchy throat. Hives reappeared for two days afterwards. Should I get the second dose?
Had a seizure with staring episodes lasted about 4 minutes when she was staring blankly.
Pregnant, due date 03/27/2021; adverse event included localized reaction at site of injection, started out as dime sized red spot around site that grew to approximately 2" in diameter.  It was very itchy and painful, required Benadryl, Tylenol and cortisone cream for treatment, and lasted approximately 2 weeks after injection.  Only occurred after initial dose.
headache, ringing in ears, vertigo, chills, sweats, no fever, exhaustion
On 3/28/03 pt with erythema and induration with edema from L shoulder almost to elbow. Child did not complain but post observing him scratching he admitted to itching. Advised heat or warm compresses, Tylenol and dipk enhydroamine. If no improvement return or seek Dr's care. 3/31/03-p.c. from mother edema continued to include entire shoulder and some of back. Dr. visit dx. cellulitis. 4/1/02 p.c. to parents child improving.
periods became very irregular; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date, the patient experienced periods became very irregular. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pneumonia of both lower lobes; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-SEP-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for routine health maintenance and for its intended purpose: the prevention of shingles by an unknown health care provider (HCP). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt. experienced coughing and fatigue and was diagnosed with pneumonia of both lower lobes (pneumonia). As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had resulted in physical limitations not presented prior to the use of the vaccine. Pt. also experienced mental and emotional distress due to resulting in physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life; physical impairment and injury; and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. At the reporting time, he was not recovered of pneumonia. The reporter considered the event pneumonia to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered pneumonia to be disabling.  Upon internal review, the event pneumonia was considered to be medically significant.
3.5cm red raised area at Varicella site. BENADRYL, MOTRIN, Prednisone, ZYRTEC.