chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/ The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/ The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/ The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/ The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The 2 shipments arrived to their offices frozen solid, but the email states that it was not frozen the whole time before it came to their hands. The reporter believes that the shipment was thawed, and then it was refrozen again during transport. The vaccines were applied to patients after being refrozen according to what caller is thinking. In total, 102 patients were administered the vaccines: 71 from the first shipment, 31 from the second shipment.  Reporter does not know the expiration date, the states stated that by their numbers, the doses were viable up to 14-Apr-2021, the 30 days since it was thawed. 0.4 degree Celsius of temperature was reached during transport.  The vaccines were applied to patients after being refrozen.
Administer Expired Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.
Several hours after receiving the Pfizer vaccine I noticed a very dark blue bruise at the injection site. I still have this bruise, about the size of a Nickle, 12 days later. There is no pain or discomfort associated with this nor do I have any other side effects.
This non-valid spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored Oka/Merck VARIVAX lot # R017642, expiration date 20-JUN-2020 (dose and route of administration were not reported) for prophylaxis. It was reported that sterile diluent used for reconstitution of the vaccines was properly stored. The suspect doses of Oka/Merck VARIVAX were stored in temperature range from 6 to 14 degrees Fahrenheit for 30 minutes (date unspecified). There was no previous temperature excursion recorded. A digital data logger was involved. No adverse effects were reported.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 02-NOV-2010 the patient was vaccinated with first dose of VAQTA (Dose: 0.5 milliliter (ml)), intramuscularly. Concomitant medications were not reported. The patient was vaccinated with second dose of VAQTA on 11-MAR-2011 and third dose of VAQTA on 22-MAY-2014. No adverse effects reported. The outcome of the patient was vaccinated with second dose of VAQTA on 11-MAR-2011 and third dose of VAQTA on 22-MAY-2014 and no adverse effects reported was unknown. Additional information has been requested.
developed shingles on unspecified date after receiving the vaccine; shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The physician received Shingrix in October 2019, and developed shingles on unspecified date after receiving the vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Pt states she developed swollen lymph nodes under her left armpit towards her breast.  The next day she had a itchy red rash at the injection site. Pt contacted her PCP and she was told to keep an eye on it and make a VEARS report since she had a reaction to taking the vax.
After dose 1, had a mild reaction and I felt strange. After dose 2, stayed 30 minutes post injection Later that evening, I felt like a train hit me. I had vomiting, fever and couldn't move. .I also experienced tingling in my left leg. I also noticed my veins becoming very pronounced. Three days after, I was feeling a rapid heartbeat and I got sweaty. I went to the ER later same day. My symptoms lasted 6-7 weeks and after which started feel like myself again. However, my heart started racing again in October. I now feel pressure in my chest when standing.
Patient stated that she felt funny EMS was called vitals HR 74 BP 142/80. Released and went home.
Patient felt dizzy right after vaccine administration and fainted and collapsed into vaccinating pharmacists arms. Patient immediately regained consciousness but still hot, dizzy, sweaty.  911 called immediately and paramedics arrived to assess vitals in the ambulance,  patient walked out of the store to the ambulance with assistance.
Pt had severe pain in left deltoid, limiting range of motion and was not relieved by over the counter ibuprofen
Info has been received from a physician concerning a 3 year old male who at 1 year of age was vaccinated with a dose of varicella virus vaccine love. Concomitant vaccination "most likely" included a dose of MMRII. Subsequently, the pt developed a classic distribution of zoster down his leg. Unspecified medical attention was sought. The pt had no hospitalizations. It was reported that the pt had healed when he presented to the office, but he had a rash for about a week. No medicines were administered. It was reported that the pt had full resolution. Additional info has been requested.
This case was reported by a nurse via sales rep and described the occurrence of hallucination in a 50-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced hallucination. On an unknown date, the outcome of the hallucination was unknown. It was unknown if the reporter considered the hallucination to be related to SHINGRIX. Additional information was received as follows: The patient was about 50 years of age and received a dose of SHINGRIX from a retail pharmacy. The patient notified the clinic nurse on the following day that she experienced hallucinations. The reporter receive this information from another nurse working at a satellite clinic and they were affiliated with which in turn to share the information with the reporter.
skin welt in the left side of her face; itchy in her face; bruising in her face; sore arm; rash on the left side of her face; general mild allergic reaction; headache; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (skin welt in the left side of her face), PRURITUS (itchy in her face), CONTUSION (bruising in her face), PAIN IN EXTREMITY (sore arm) and RASH (rash on the left side of her face) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included ATORVASTATIN for Blood pressure management.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced URTICARIA (skin welt in the left side of her face), PRURITUS (itchy in her face), CONTUSION (bruising in her face), PAIN IN EXTREMITY (sore arm), RASH (rash on the left side of her face), HYPERSENSITIVITY (general mild allergic reaction), HEADACHE (headache) and FATIGUE (felt tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of Gel on her face. On 15-Apr-2021, URTICARIA (skin welt in the left side of her face), PRURITUS (itchy in her face), CONTUSION (bruising in her face), PAIN IN EXTREMITY (sore arm), RASH (rash on the left side of her face), HYPERSENSITIVITY (general mild allergic reaction), HEADACHE (headache) and FATIGUE (felt tired) had resolved.            Patient had mild allergic reaction to the second dose which started one and a half hour after the second dose. After putting Benadryl gel on her face, symptoms were gone away after 20-30 minutes. She also had sore arm, headache and felt tired during the same day.
Heart Pounding, Increased Heart Rate and Resting Heart Rate, Racing Heart, Chest Pain, Lightheadedness, Shortness of Breath, headache, dizziness, Increased blood pressure from excellent (90/60) to between 121-137/80 the majority of the time.  I saw a cardiologist who ordered blood work, an echocardiogram, and an event monitor to be worn for 30 days.My echo was the same as my last one, the blood work was fine, the event monitor showed an increased heart rate and bouts with racing heart. The event monitor showed a resting heart rate of over 100 beats per minute for an hour and a half. I have had a three hour and four hour episode of racing heart before the monitor was ordered after the vaccine.  The doctor did not order treatment. I still have the same symptoms.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. 69/M PMHx of metastatic prostate Ca and non-Hodgkins lymphoma, systolic HFrEF, DMII, chronic prednisone therapy and chronic anemia. Presented from clinic on 11/19/21 w/acute hypoxic respiratory failure 2/2 Covid-19 PNA. Tx'd w/remdisivir, dexamethasone, vanc, cefepime, pressors and HFNC. O2 demands cont. to increase transferred to ICU on 11/26, intubated 11/30. Developed acute encephalopathy,  severe sepsis w/multi-organ failure and shock. Expired 12/09/21.
pt recv vax 1NOV96 & pt devel vomit & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 225 cases reported by a pharmacist;
Patient was sitting in observation and her daughter noticed the left eye was swollen. She told us that her mom gets botox and fillers all in her face. She gets the hyaluronic acid filler apriline. She declined treatment and felt fine otherwise. She will contact her doctor.
Vomiting and Severe Diarrhea! started at 6am 4/7/2021 and has not stopped yet at 5pm in the afternoon!!! and a temperature of 100.4
child received covid #3 and Tdap #2 today.    had already gotten  tdap on 6-15 and covid 6-15 and 7-6-21.  PCP notified.
flu like symptoms; fatigue; 98.7 temp (my baseline is 97.5); This is a spontaneous report from a contactable Other HCP. A 65-year-old male patient received first dose of BNT162B2 (Batch/lot number: EK9231) on Arm Right via an unspecified route of administration on 29Dec2020 12:00 at single dose for COVID-19 Vaccination. Medical history included cardiac history. Patient had No Known Drug Allergies. Patient did not have covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine, acetylsalicylic acid, ascorbic acid (ASPIRIN), atorvastatin. On 29Dec2020 13:00, the patient experienced flu like symptoms, 98.7 temp (my baseline is 97.5) and fatigue that lasted for approximate 8 hours. The patient did not received treatment for the events. The patient did not have covid tested post vaccination.  The outcome of events was recovered.
Hospitalized 7/7/22-7/12/22 hypoxia, respiratory failure, AKI, PNA, lethargic, elevated troponin, hypotensive, dysphagia, confusion, GI bleed, anemia,
30 minutes after 1st  injection lips and tongue started tingling and swelling 4hrs after injection ulcers started forming inside mouth under top lip
Patient says she wasnt feeling well about 3 hours after shot. She went to the ground and reports feeling paralyzed. She says it lasted for about 6 hours and she also started to vomit after 4 hours. When she was able to move again she reported having a headache that lasted for a few days.  Patient says she is feeling fine now with no symptoms or issues.
Treatment of COVID-19; Treatment of COVID-19; Janssen Dose Number: 1, Pfizer/BioNTech  Dose Number: 2 / Moderna Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Oct2021 as dose 2, single (Lot number: FF2590) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Sep2022 at 15:15 as dose 3 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 19Mar2021 as dose 1, single (Lot number: 1808609), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: JENCYCLA, start date: 05Aug2021; FLUOXETINE, start date: 09Apr2020. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2021, outcome "unknown", described as "Janssen Dose Number: 1, Pfizer/BioNTech Dose Number: 2 / Moderna Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There were no known allergies. The patient received other medications (Jencycla and Fluoxetine) in 2 weeks. Antiviral details: The patient received Paxlovid from 01Feb2023 to 06Feb2023 for treatment of COVID-19.
heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Overweight.   On 27-Apr-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heart rate increased). At the time of the report, HEART RATE INCREASED (heart rate increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Malaise, lymphadenopathy in left neck hives starting within 2 hours of vaccine injection in left deltoid. Hives resolved still has lymphadenopathy.
shingles; Information has been received regarding a case in litigation from a lawyer, and a  female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-APR-2015, at age 68, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: injury to themselves, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Within 12-24 hours developed flu-like symptoms (fatigue, fever, myalgia, dysphonia) Within 1 month developed recurrence of pericarditis symptoms
This spontaneous report was received from a female patient of unknown age who was reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 0.5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis. Since an unknown date (reported as for the last couple of days), the patient's arm felt like it had been hit by a baseball bat and there was a tingling feeling going down through her fingers. The patient did not seek medical attention. The outcome of the events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not reported.
Broke out in a rash (Injected arm) for 5 days after first shot; Swelled (Injected arm)  for 5 days after first shot; Red Injected arm (For 5 days after first shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Broke out in a rash (Injected arm) for 5 days after first shot), VACCINATION SITE SWELLING (Swelled (Injected arm)  for 5 days after first shot) and VACCINATION SITE ERYTHEMA (Red Injected arm (For 5 days after first shot)) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Broke out in a rash (Injected arm) for 5 days after first shot), VACCINATION SITE SWELLING (Swelled (Injected arm)  for 5 days after first shot) and VACCINATION SITE ERYTHEMA (Red Injected arm (For 5 days after first shot)). At the time of the report, VACCINATION SITE RASH (Broke out in a rash (Injected arm) for 5 days after first shot), VACCINATION SITE SWELLING (Swelled (Injected arm)  for 5 days after first shot) and VACCINATION SITE ERYTHEMA (Red Injected arm (For 5 days after first shot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Information has been received from a pharmacist concerning patient who on an unspecified date was vaccinated with a dose of Recombivax HB (manufacturer unknown). Additional suspect therapy included a dose of PedvaxHib (manufacturer unknown). Subsequently, the patient developed blood in the stool, but it was thought to be a possible allergy. No further information is available. The patient's siblings, (WAES # 0610USA12034) had a similar experience after vaccination.
Started with a rash that resembled eczema and spreaded all over his body within a week after a flu vaccination containing thimerosal.  Behavioral he became hyper and listless.
Menstrual cycle was to begin on May 12.  Did not have cycle again until July 1.
This spontaneous report as received from a consumer refers to his 15 year old daughter with none of Pertinent Medical History and Drug Reactions/Allergies. On an unknown date the patient was vaccinated with the first, second and third dose of GARDASIL (lot number, dose, and frequency were not provided). On an unknown date the patient experienced cataplexy and narcolepsy after receiving the third shot of GARDASIL. The patient saw the doctor. Routine blood work was performed which result was not provided. The outcome of cataplexy and narcolepsy was reported as not recovered/not resolved. The causality of event was not provided. Additional inforamtion has been requested.
Fever 99.8, bad headache, leg pain. Feels just like bad case of the flu.
Erythema, swelling , itchiness. Rx: Benadryl PRN.
Became faint diaphoretic and vomitted after 2 injections. Within 1hr states migraine headache and diarrhea. Migraine lasted at least 24 hrs with Maxalt MLT 10mg x3. 8hrs after vaccines Temp 101.3 and dull pain in left arm. Next AM left arm "pain in bones all the way down my arm." Inj sites unremarkable. Advised to see PCP or go to Emergency Room if desired
Chills, nausea, fever(102) Saturday except for temperature of 100 all symptoms were gone.
Kinrix expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 12-MAY-2023, the patient received Kinrix. On 12-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-MAY-2023 An expired dose of Kinrix was administered to a patient which led to expired vaccine used. The reporter consented to follow up via mail.