chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received vaccine Fluzone High Dose(unopened), that was not suitable for use post a temperature excursion with Thyphim (unopened), Ipol (Opened, unopened) and Tubersol(unopened)at -17C degrees for 63 hour and 45 minutes due to unknown cause with no ae; Initial information regarding this unsolicited valid non-serious case was received from a other health care professional and transmitted to Sanofi on 14-Oct-2020.  This case involved a 79 year old female patient who was administered with a 0.7 mL dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (unopened) (lot UJ450AA) via unknown route in the left deltoid for prophylactic vaccination, on 09-Oct-2020, that was not suitable for use post a temperature excursion with IPV (VERO) [IPOL] (opened, unopened), TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (unopened) and INFLUENZA and TUBERCULIN TEST [TUBERSOL] (unopened) at -17 degrees Celsius for 63 hour and 45 minutes due to unknown cause.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.    It was an actual medication error case due to product storage error temperature too low.  At the time of reporting, 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.
Approx 8 hours after injection pt reported throbbing and swelling at injection site. Redness, irritation and pain moved from injection site down past elbow. Pt also reported heat in the affected area.
Client states the first day had moderate to severe panic with heart racing for 2 days and came back on 8th day.  Body became completely numb for 2-3 days during the first week and couldn't feel anything. Client states had normal symptoms of fever, chills, "anger outburst that was severe on the 22nd at 1030" lasted for 4 days. Client states has not been able to ejaculate since receiving the vaccine.
Pt complained of fever 101.8, itching, chills and red, raised injection site 3 to 5 inches in diameter.
This spontaneous report as received from a consumer refers to her son, a male patient of unknown age. On 19-MAR-2013 the patient was vaccinated with a first dose of GARDASIL (route and lot number were not reported). No other concomitant medications were reported. The reporter stated the patient did not have any warts on his hand before getting the vaccine, and about 3-4 weeks ago, in approximately on 02-APR-2013 the patient developed one wart on his hand. The patient had been to see a dermatologist. The outcome of wart on his hand was reported as not recovered. The relationship between GARDASIL and the wart on his hand was unknown. Additional information is not expected.
Initial report received on 22 September 2011 from a nurse. This case involves one 4-month old patient who is part of a cluster of 3 patients from the same reporter, and with the same vaccines administered. Information regarding the other 2 patient who are also 4 months old have been captured in case number 2011-09210. A 4-month-old male patient (dates of birth unknown) who had no concurrent illnesses, and no known allergies had received a second intramuscular right leg injection of ACTHIB (lot number UH409AA, sanofi pasteur SA lot number G1317-1), and a second intramuscular left leg injection of DAPTACEL (lot number C4002AA), and an intramuscular right leg injection of PREVNAR (Wyeth, lot number 916973) on 20 September 2011 and the following day the patient was brought back to the office with swollen right foot that started the same day of vaccination. The patient required medical evaluation and was advised to take TYLENOL for the swelling and irritability. It was reported "med RX not available for demographics". No relevant diagnostic tests and or laboratory data were performed. Twenty-five gauge, 5/8 inch (15.875 mm) needled were used for the vaccinations. The patient recovered on an unspecified date. Documents held by sender: None.
When patient's mother attempted to complete the screening questions, she was stopped when she entered the birth date of the patient informing her that he is not eligible for the Moderna vaccine due to age.  She then entered "unknown" for his birth date and was permitted by the system to continue.  When she arrived at the clinic with the patient, she informed the vaccinating nurse that "His doctor gave permission for him to get the vaccine.."  The vaccine was administered.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 04-AUG-2014 the patient was vaccinated with the first dose of GARDASIL (strength and lot # unknown) 0.5 ml, intramuscular. The patient was administered the second dose of GARDASIL on 03-OCT-2014 and the third dose of GARDASIL on 22-OCT-2014. No adverse effects reported. Additional information is not expected because the reporter doesn't want to be contacted.
About 6 hrs post receiving, PT developed severe pain in joints that increased during night and next day. Pain began to lessen 2nd day after vax, and was gone by end of that 2nd day. Also c/o entire body ached.
sick; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; felt warmth in the arm; hot flash; just got really hot; This is a spontaneous report from a contactable consumer (patient himself).  This 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140), via an unknown route, on 23Dec2020 (at 06:00 AM), at single dose in the left upper arm on 23Dec2020 for COVID-19 immunization, administered at hospital. The patient had COVID-19 from 17Jul2020 to 14Aug2020 for which he was not hospitalized but he was pretty sick and had circulations issues; he had a little of numbing and tingling in his left three fingers after COVID virus. The patient clarified left three fingers as his middle finger, index finger, and ring finger. He had numbing and tingling in his toes as well. Relevant concomitant medications included ubidecarenone (COQ-10), rosuvastatin calcium (CRESTOR OD), monascus purpureus (RED YEAST RICE PLUS), and acetylsalicylic acid (BABY ASPIRIN). With the first dose he got tired and had malaise, and body aches for two days: He got the vaccine after working that night (He works in the intensive care unit). He got it at 6:00 AM. He felt warmth in the arm. It went all the way down the left arm. He got a hot flash. He stayed there for 15 minutes and was fine, but just got really hot. He finished his shift and didn't have any other reactions. He went to sleep and woke up in the afternoon on the 23Dec2020 and went to work. He didn't feel anything at that time. He was working six or seven days in a row. When he was working that night was when he started feeling body aches and fatigue. He didn't even put two and two together that it was from the vaccine. He felt like he needed to take something. His body temp was normally 97 and when he checked it was 98. He took a little ibuprofen (MOTRIN) and felt a lot better after taking it. He slept when he got home and had body aches and fatigue for a couple of days. He cancelled going away for a couple of days. By noon on 25Dec2020 he was feeling like he was getting back to normal. He continued to lay around all day and didn't do much. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. The patient had recovered from the event 'with the first dose he got tired and had malaise, and body aches for two days' on 25Dec2020 while the outcome of the remaining events was unknown.
Received TD booster on 11/5/01. Right deltoid developed arm pain and stiffness and stiffness into her neck and shoulder.
Started noticing random paresthesias in face, arms and legs that started on 12/21/20. After receiving vaccine on 12/17/20. Paresthesias have improved but are still present. No weakness or loss of reflexes. Had a normal work-up in the ER and following up with PCP and neurology.
She had diareah and nausea for a few days with 1st shot but it got better. She complained about "feeling off" after the 2nd shot. Went to bed to try to sleep it off and she never got up again.  We think she died Wednesday night or Thursday morning by how she stopped responding to texts. She was found deceased on Friday.  They won't do an autopsy here.  funeral home has her for now.
very stiff body; feeling poor; injection site is red; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (very stiff body), MALAISE (feeling poor), INJECTION SITE ERYTHEMA (injection site is red) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 001A1A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (very stiff body), MALAISE (feeling poor), INJECTION SITE ERYTHEMA (injection site is red) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (very stiff body), MALAISE (feeling poor), INJECTION SITE ERYTHEMA (injection site is red) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No treatment medication details was reported.
Swelling of Left arm at site and down arm next day. Large swelling behind arm where Proquad given. Patient experienced heat coming from site and was taken to emergency room. Emergency Dr. advise to tell us.
immed p/vax pt devel bruising 30min p/leaving MD office;petechiae devel on face & trunk;pt was in no distress;
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. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 16-JAN-2012, at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-AUG-2015, the patient was treated for a blistering vesicular eruption, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX, acyclovir, and ointment for management of her ongoing and painful symptoms. As a direct and proximate result of these malfunctions, 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.
5/28/99 exposure to child w/chickenpox? from varicella vaccine;6/7/99 well & recv vax;6/17/99 fever w/profuse sl raised pink rash over entire body-fever lasted 2 1/2 days-rash slowly faded over 6 days;
On 4/3/21 the patient presented with a 1 week history of slowly progressive shortness of breath and 3 day history of left upper quadrant pain.  CT revealed bilateral segmental and subsegmental pulmonary emboli, moderate splenic enlargement, and small volume perisplenic hemorrhage. Continuous infusion heparin was started for the bilateral PE. On 4/4 an inferior vena cava filter was placed and patient was vaccinated with Acthib, Bexsero, and Prevnar vaccines in anticipation of splenectomy. On 4/7 a laparoscopic splenectomy was performed. The spleen was evaluated by pathology which reported "Organizing blood clot on surface, consistent with rupture. No evidence of malignancy." The patient remains inpatient while recovering from surgery. On 4/12 she was transitioned to rivaroxaban for therapeutic anticoagulation. Please note as of 4/13 the patient remains hospitalized.
Herpes outbreak below nose. No record of herpes before.  Just now healing. After 1st dose on 3/9  lot# 036a21A had similar outbreak  on back or left thigh.
No adverse effect reported; patient received improperly stored VARlVAX; This spontaneous report was received from a nurse referring to a patient of unknown age. Concomitant therapies included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided.     On 05-SEP-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S005078, expiration date 19-FEB-2021 or lot # R019237, expiration date 04-JUL-2020; strength, dose, frequency and route, were not provided) for prophylaxis.  (product storage error). Both lots of varicella virus vaccine live (oka/merck) (VARIVAX) that underwent the temperature excursion were added to the case since the office did not know which lot was given to which patient. It was stated that the vaccines were exposed to a temperature between -14 to -10 Celsius degrees (-9.74 Celsius). Time frame was unknown. A digital data logger was involved. No previous temperature excursion was reported. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.
2-3 hrs p/vax pt devel fever up to 104 & vomiting; parents using APAP suppositories; called MD & took to MD 1JUL92;
While in observation following vaccination, at 12:05pm patient reported symptoms of anxiousness/nervousness, light-headedness, and appeared to be emotionally distressed. Patient's legs were elevated, O2 administered via non-rebreather mask 10 LPM, pulse ox 100% and pulse 65 bpm. Patient's symptoms resolved around 12:20pm and patient left without further issues.
Occasional shortness of breath combined with a flutter, thump in center of chest.  Probably one "episode" every 30+ minutes.   I can feel it coming on and then resolving after a thump.   Sleeping has helped some.  Today I feel better than yesterday.    I have had this before in my life, triggered by stress.  Never diagnosed with heart condition.
37 y/o male developed a moderately large local reaction over left deltoid involving erythema, tenderness, & left axillary tenderness without warmth, rash itching or systemic symptoms; swelling measured 35 x 35 mm; reaction onset was within 24 hrs following receipt AVA#7 & MGC vaccines both given in left deltoid on 9/18/2009. Prior dose of AVA#6 was May 2000. Pt reported swelling was improved but not resolved by 9/24 so he RTC on 9/24 for f/u - diagnosed with possible cellulitis & prescribed oral antibiotics.
I contracted COVID 1/28/2022. Symptoms include runny nose and mucus for 1 week prior. I was medicating myself with allergy and mucus OTC meds. I went to doctor on 01/21/2022, I was prescribed Z-PAC, antibiotics, and a shot. One week later, 01/28/2022, I was not better and had a COVID test which was positive. A week later the most symptoms went away. I went to doctor and he found a heart murmur. I went to a cardiologist and said that the murmur was due to effects of after COVID-19. I am in the process of getting an echocardiogram to find out more.
Information has been received from a licensed nurse practitioner concerning an 8 week old female with no drug allergy and no medical history who on 19-OCT-2011 was vaccinated with a dose of ROTATEQ, 2 ml (lot# 668905/0560AA, expiration 30-JUN-2012). There was no concomitant medication. The nurse reported that on 19-OCT-2011, during administration, the patient made a "horrible gaggy face", and the baby gagged. The patient also screamed and cried during administration. The patient's skin became cool and clammy after the patient received the dose of ROTATEQ. No treatment was given for the AEs. No lab diagnostics studies were performed. The patient was seen and assessed by the nurse practitioner. Nurse suspected a quality issue with this vaccine as this is one of two doses that were administered from this same lot and expiration. The nurse requested a lot check for ROTATEQ (lot # 0560AA expiration 30-JUN-2012). Product quality complaint involved. The follow-up information has been received from the licensed nurse practitioner concerning the patient, a two month old female who at AM of 19-OCT-2011 was vaccinated with her first dose of ROTATEQ. The nurse reported that the patient became clammy and skin was blotchy and cold after vaccination at AM of 19-OCT-2011. During administration, the patient was very fussy and made faces like ROTATEQ tasted bad. The patient also screamed and gagged. The patient recovered on 19-OCT-2011. The patient had no illness at time of vaccination. The patient had no pre-existing allergies, birth defects or medical conditions. The follow-up information has been received from the licensed nurse practitioner concerning the patient, a 8 weeks old female who at AM of 19-OCT-2011 was vaccinated with her first dose of ROTATEQ. The nurse reported that during ROTATEQ was administered orally, the patient became fussy and made horrible gaggy face and gagged as if going to vomit. The patient screamed and moved head side to side. The patient's skin became cold and clammy. The nurse practitioner evaluated the patient. No relevant diagnostic tests were performed. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. This is one of several report received from the same source. No further information is available.
Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Sep-2021 and was forwarded to the company on 16-Sep-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 3:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered,administered with the vaccine on 16Sep2021 (3:45pm) from a vial that was first punctured on on 15Sep2021 (10:15am)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. Consumer was administered a dose out of a vial that was left out the fridge for more than 24 hours. The dose was administered on 16Sep2021. Not known if it is patient's 1st or 2nd dose. Healthcare provider (HCP), a pharmacist states that a patient has been administered with the vaccine today, 16Sep2021 (3:45pm)  from a vial that was first punctured on 15Sep2021 (10:15am) with lot number 014F21A.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow up received on 16 Sep 2021 contains reporter, patient information and dose information
COUGH; RUNNY NOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's pre-existing medical conditions included: The patient did not have any known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-DEC-2021, the patient experienced cough. On 08-DEC-2021, the patient experienced runny nose. The action taken with covid-19 vaccine was not applicable. The patient recovered from runny nose, and had not recovered from cough. This report was non-serious.
starting that evening of the vaccine, pt developed tremors, paresthesias, erectile dysfunction, nausea, vision changes, chest pain, insomnia, and palpitations. The chest pain resolved with tylenol. The other symptoms have not remitted.
9 year old child was the recipient of Pfizer, purple cap. This was the childs first covid vaccination.
Post 3rd dose of vax, the pt became extremely pale and diaphoretic. Within 5 seconds after injection, pt had a convulsion lasting approximately 10 seconds. She then became alert for a few seconds and then had a second convulsion. Afterwards she became nauseated and vomited approximately 100 cc of clear fluid. EMS arrived and within a few minutes pt's color was returning and her BP was returning to normal. Pt was placed on oxygen via face mask for a couple of minutes. Pt refused to go with EMS and remained at health department for another hour to recover.
getting sick; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced getting sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious getting sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.