chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three days after I received the ZOSTAVAX injection , I broke out with a rash on my right arm. It was 2-3 cm wide, consisted of pruritic small red papules and extended from the medical aspect of my wrist across my arm and ended at my elbow. The rash persisted for about 10 days. IN August 2008, I noted a 1.5 cm tender lymph node in my right axillary are, with no other signs or symptoms of infection. It lasted about one week. The following week, I began having chills, fever, and symptoms of a mild URI. About the third day of chills and fever, I also noted a purulent nasal discharge and pain in my posterior neck. I consulted a doctor at a local walk-in clinic, and he drew a CBC and sed rate and gave me a prescription of CIPRO. He did not tell me the results of the CBC, but he did say the sed rate was elevated "indicating that I had some type of infection". The next day, I broke out with a  large herpes simplex lesion inside my nasal passage, and the chills, fever, and pain in my neck disappeared. After that, I had another outbreak of herpes simplex in my nose about one month and two months from the initial outbreak. On Friday January 16th, 2009, I had fatigue and muscle aches. The next day, I broke out with 2 herpes simplex lesions on my upper lip. I also kissed my husband on January 16th, and the next day he broke out with herpes simplex lesions on his lip. I do feel that the rash on my arm was a direct result of the ZOSTAVAX injection, even though it did not appear vesicular. I cannot prove that the herpes simplex lesions are a result of the vaccination, however before I took it, I was not prone to have recurrent herpes outbreaks, and certainly not this frequently, and not with severe prodromal symptoms like I have had. My husband and I are both 65, happily married, monogamous and devout Christians. I did previously work in public health as a nurse practitioner and examined patients in the family planning and STD clinics, but I retired 2 years ago, and have no contact with the patients since then. I seek no damages or compensation for this report. My only wish is to record my experience in case other patients have had or will in the future have problems with ZOSTAVAX. I have no regrets for taking the vaccine. Herpes simplex will be a small price to pay to prevent herpes zoster.
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via The Agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310706, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt got vaccine at 12pm and woke up at 12am after sleeping on his stomach with liquid in throat and rapid breathing 2-3 times normal rate. lasted for 3 hours and then resolved without intervention.
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a non-other healthcare professional. This case involves 12-year-old female patient who was vaccinated with a dose of suspect vaccine MENACTRA lot number: U5948AB (expiry date, dose details were not reported) in May-2017. The patient's medical history was not reported. Concomitant medications included ADACEL for Immunisation. It was an actual medication error due to inappropriate schedule of drug administration. In May 2017, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On 02-Jul-2018 she also received a dose of the same vaccine lot U5948AB via unknown route in unknown administration site. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
10/29 - Red macular rash.  Itchy, warm to touch.  11/01 - Red blotchy, itchy rash, warm to touch.  Disappeared on own.
4NOV97 pt devel visual disturbances followed w/in a couple of hr by lt facial paralysis;pt also devel some weakness lt arm & lt leg;pt was hosp 4NOV97 & discharged 6NOV97 w/illness unresolved;dx of bell's palsy was given;
Significant left arm swelling, redness, and pain starting 24 hours after shot and progressing throughout the day. Arm girth was 2" larger than other side and skin tight and indurated surrounding site of injection from shoulder to elbow.
A BRAIN CLOT; SEIZURES; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had a brain clot, and seizures. The reporter stated that " Their Covid-19 vaccine gave my daughter a brain clot and seizures ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a brain clot and seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221049075-covid-19 vaccine ad26.cov2.s-seizures . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20221049075-covid-19 vaccine ad26.cov2.s-brain clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
After my second vaccine, I have developed a dry cough/I have had the cough for 24 hours so far; at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); at the same time I experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally); This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular at single dose in the right arm, first dose (lot: EK5730) on 17Dec2020 11:30 am, second dose (lot EL0142) on 07Jan2021 18:00, both for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. After his second vaccine, on 08Jan2021, he has developed a dry cough at the same time he experienced the more typical symptoms (mild fatigue, malaise, muscle aches, fever of 100.0 orally). He has no known exposure to Covid 19 in the last few weeks. He has had the cough for 24 hours so far. The patient did not receive any treatment. Outcome of events was recovering.
Got dizzy and had passed out.  Hot and sweaty and a long time to recover.  Body soreness, headache, neck pain and dizzy spells the remainder of the day.
This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 27-OCT-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 patient was vaccinated at a private healthcare center and the vaccine was purchased with Medicaid-VFC (public fund). 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 has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
pneumonia; COVID-19; Off label dosing frequency; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) and COVID-19 (COVID-19) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for Headache.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (COVID-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced OFF LABEL USE (Off label dosing frequency). At the time of the report, PNEUMONIA (pneumonia) and COVID-19 (COVID-19) outcome was unknown and OFF LABEL USE (Off label dosing frequency) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Oxygen saturation: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included Covid antibodies.  Company comment: This is a case of Off label use with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded. Event pneumonia was automatically upgraded as a serious event as list. Events Pneumonia and COVID-19  were upgraded to hospitalization seriousness criteria as per narrative in SD and per medical judgement, despite the were reported as non-serious.; Sender's Comments: This is a case of Off label use with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and other reported events, a causal relationship cannot be excluded. Event pneumonia was automatically upgraded as a serious event as per list. Events Pneumonia and COVID-19  were upgraded to hospitalization seriousness criteria as per narrative and per medical judgement, despite the were reported as non-serious.
Arm started swelling; Getting very red; Tender; Really hot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Getting very red), TENDERNESS (Tender) and FEELING HOT (Really hot) 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 02-Feb-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Getting very red), TENDERNESS (Tender) and FEELING HOT (Really hot). At the time of the report, PERIPHERAL SWELLING (Arm started swelling), ERYTHEMA (Getting very red) and TENDERNESS (Tender) outcome was unknown and FEELING HOT (Really hot) was resolving.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient admitted 1-2 days following administration of the vaccines to hospital with multiple B/L PEs, Question of saddle embolus, now intubated, had been on pressors, had bleeding and not able to tolerate TPA as result
Vaccine went into the eye of one of the vaccine providers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into the eye of one of the vaccine providers) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into the eye of one of the vaccine providers). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into the eye of one of the vaccine providers) 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.
Swollen lymph node under the armpit on the same side as the injection.  Very painful and visually swollen. Still swollen 45 hours after injection.  Its more swollen at 45 hours than it was at 24 hours.  Ibuprofen and tylenol help slightly.
24 hours after injection:both arms and legs experienced flacid paralysis, breathing became labored, heart beat became erratic and pounding, nauseous, lump formed in my throat, sweated profusely all for 30 minutes. All symptoms subsided immediately after except for disorientation. I immediately called doctors office to inform them of the side effects. I walked four blocks to the doctors office and they informed me they were unaware of any side effects and if I became symptomatic again to go to the emergency room.
Shortness of breath. (Lasted for two weeks).  Occurred several times during each day.  Mostly when talking   Headache  Very tired   I did not go to doctor during events. The shortness of breath would come and go daily for two weeks.  I was able to function. I am concerned if I should get the second shot which I have scheduled for this Friday, February 12, 2021.
First pregnancy - EDC 09/18/21, RH negative (spouse is positive), Advanced maternal age  - First adverse event on 09/11/21 included minor spotting while using the bathroom 2 days after 2nd dose of the Pfizer shot - pregnancy at 17 weeks, 1 day. I contacted my doctor via the online message system and advised her of the spotting. She instructed me to rest and take fluids.  - Second adverse event on 09/13/21 (17 weeks, 3 days pregnant)- I woke up with a swollen right eye, which was crusted shut with mucus. My first thought was that it was either debris in my eye or pink eye. I made an appointment with the eye doctor and he said that it's likely a stye forming and to use a warm compress.  - Third adverse event on 09/16/21 (17 weeks, 6 days pregnant) - I tried using the bathroom to pass a stool and was finding myself a bit constipated (which hasn't been uncommon in this pregnancy). I experienced enough bleeding to have blood in the toilet and continuous blood while wiping. I went immediately to the ER for treatment.
no additioanl AE reported; Caller states the vaccine was administered after a temperature excursion; This spontaneous report as received from a Medical Assistance, referring to a patient (gender and age not reported). No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 28-JAN-2021, the patinet was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) with a valid lot # T012551, at a dose of 0.5 mL (dose number, route and anatomical location not provided) for prophylaxis, however no additional adverse effects reported.  Administered dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)  experienced the temperature excursion above -13.8 degrees Celsius for 41 minutes. Digital data logger was involved. There were no previous temperature excursions reported.
Cellulitis, fever, body aches, night sweats. Pt prescribed cephalexin 500 mg to take as prescribed. Pt agreed with treatment plan. Patient was also given ROCEPHIN 1 gram in clinic and to follow up as needed. Patient will call or return if symptoms worsen.
Achey, swollen, red joints from fingers to toes, fatigue, chills, fever the next morning after flu vaccine. Given rx for Ibuprofen 800mg tid. Later, Nalofen.
PER PROVIDER'S ORDER AND DID NOT DOUBLE CHECK THE PATIENT'S AGE, VACCINATED TO EARLY AT THE AGE OF 8
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 14-OCT-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 has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706.
painful arm;hand cool, plethoric w/delayed capillary refill;MD ofc called reflex sympathetic dystrophy;local hand surgeon called hand arm synd very improved last time spoke
10/24- Numbness of tongue & headache 5 pm. 10/25-School nurse called, numbness of the right side of face. Took patient to the doctor diagnosis, was Belle's Palsy 12 pm. Blood test ordered for Lyme. 02/06/07-records received and reviewed: DX Bell's Palsy on 10/25/05 11/7/05-doing better but still complains of right ear pain with intermitten throbbing.
ONE CM SLIGHTLY RAISED FLESHY COLORED PAPULE, TO LEFT SHOULDER.  PATIENT C/O "ITCHY".  NON-ERYTHEMATOUS, WITHOUT PUS DRAINAGE.  PATIENT STATES PRIOR H/O SIMILAR EPISODES.
2 DAYS POST VACCINATION A RED RASH DEVELOPED AT AND AROUND THE INJECTION SITE.
2nd covid vaccine was administered 10 days too soon.  Parent notified, recommendation is to repeat vaccine dose 3 weeks post incorrect vaccine.
Fever and left leg swelling; went to left knee swelling and 2 days after still febrile went to left wrist swelling- polyarthritis related to influenza vaccine.
One week after the shot I experienced two bright red, very itchy, hot to the touch red bruise that are traveling down my arm I asked a provider what they thought and thought it was possible cellulitis.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot number: M032141 with an expiration date of 02-OCT-2017; dose regimen details and anatomical location were not provided) reconstituted with sterile water diluent (unknown lot number and expiration date) for prophylaxis. The sterile water diluent did not undergo an excursion. The temperature was 6°F to 14°F for a time frame of  2.5 hours and 15°F to 46°F for 1.5 hours. No previous excursions were reported. The temperature excursions were detected by a data logger. There was no PQC involved. This is one of two cases from the same reporter. Additional information is not expected since consent to contact the patient's physician was not provided.; Sender's Comments: US-009507513-1705USA004671:
Information has been received from a registered nurse concerning a 75 year old female consumer who on 13-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 25-MAR-2008 the patient called the office and reported blisters on her trunk. The nurse diagnosed the blisters as shingles from the patient's description over the phone. The patient was referred to her physician. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the patient was not tested because she recovered on an unspecified date. Additional information has been requested. This is one of several reports from the same source.
Patient presented w/ redness, swelling in large area, surrounding injection site. Hot to touch & painful. Was going to ice & use BENADRYL.