chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 4:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 48.45.  Concomitant products were not provided.  On 27-OCT-2021, Excursion time was reported at 9:00 A.M and 10:00 AM with temperature as 29 and 32 degrees Fahrenheit, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-SEP-2021 and 05-OCT-2021, vial was moved to clinic on 27-OCT-2021. 2 and 4 vials were sent to clinic. Vaccine BUD date was 27-OCT-2021 and 04-NOV-2021.  Vial was stored on cooler 1, on 27-OCT-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 PM: 43, PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: bradycardia-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium
Rash on neck appeared - first noticed at 7:30 pm. Described as mildly itchy and painful to touch
Fever X 3 - 4 days, Seizure X one 6/28/2007 and X one 6/29/2007,  listlessness and poor feeding
Slight reaction; Pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (Slight reaction) and INJECTION SITE PAIN (Pain in the arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced ADVERSE REACTION (Slight reaction) and INJECTION SITE PAIN (Pain in the arm). At the time of the report, ADVERSE REACTION (Slight reaction) and INJECTION SITE PAIN (Pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-127871, US-MODERNATX, INC.-MOD-2021-127431 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127871:Baby case US-MODERNATX, INC.-MOD-2021-127431:Husband case
Per Patient: I had the vaccination on Thursday around 9:30 am - at 7:00 pm that night I started having chills and had a fever all night. I also had a loss of appetite and nausea. Friday morning I had a terrible headache and was still not hungry. By around mid-day on Friday I finally got rid of the headache and was able to eat (though the nausea persisted a couple more days whenever I ate). And, my arm was really sore until Sunday (though it's still tender today (Monday)). I did not develop any kind of welt or anything at the injection site - it was just a little red around the immediate area on Friday and Saturday.
Information has been received from a nurse via a company representative referring to a male patient under 2 years of age. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, dose, dose# and route unknown) (inappropriate schedule of drug administration). No adverse event was reported. Additional information has been requested.
No further AE; an expired dose of VARIVAX was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 09-MAR-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 injection, lot# S002738 with expiration date 28-JAN-2021; strength and route of administration were not reported) for prophylaxis (expired product administered). The vaccine had no temperature excursion. Dose was supported in potency for 6 months post-expiry per memo. No further adverse event (AE), No product quality complaint (PQC) was involved in this case.
Pt received Tetanus Booster on 08/08/2002. On 08/09/2002 developed small rash all over body. Looked like bug bites. Parents applied calamine lotion. On 08/10/2002 rash all over body and evening parents noticed 3 x 5 inch rash/bruise on back. on 08/11/2002 pt woke up with bruises all over body and petichae all over fingers, toes, and nose were cyanotic. By 08/12/2002- parents seen made improvement " pt showed no neg signs of reaction. Advised parents to bring child in for care- they refused because he was better.
Mid April, wife called ambulance due to worsening behavior at home, wife is only caregiver, and he became difficult to manage. Initially transported to hospital, unknown length of stay, d/c'd to Rehab, unknown length of stay, and when case pulled fire alarm at rehab facility, he was then returned to Hospital, no beds, so finally transported and admitted to Health Center on 5/6, where he tested (+) for COVID. Wife denies symptoms, no cold/flu/allergy/covid suspected symptoms.
Had weakness, dizziness, and a crawling feeling over body. BP 114/76 and radial pulse 73. No difficulty breathing.  Color good. At 1:30 PM crawling feeling better, but still dizzy and weak.  Sent home to take a Benadryl.
a little restless; brain fogginess/looped out in my head; sore arms; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (a little restless), FEELING ABNORMAL (brain fogginess/looped out in my head) and MYALGIA (sore arms) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 025A21A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced RESTLESSNESS (a little restless) and MYALGIA (sore arms). 08-Nov-2021, the patient experienced FEELING ABNORMAL (brain fogginess/looped out in my head). The patient was treated with TRAZODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RESTLESSNESS (a little restless) and FEELING ABNORMAL (brain fogginess/looped out in my head) had not resolved and MYALGIA (sore arms) was resolving.            Concomitant drugs were not reported. Treatment included swim spa.  The patient thought that might have received a incorrect dosage.   This case was linked to MOD-2021-381283 (Patient Link).
The shot instantly made my arm, fingers numb. I waited the 20 minutes and after I left felt a burning into my face that is still present 8 days later.  My face is now drooping and I am a healthy 41 year old who was diagnosed after the vaccine with Bell?s palsy.
I WARNED MY HUSBAND NOT TO GET THIS EXPERIMENTAL TEHNOLOGICAL COMPUTER SYSTEM JUNK BUT HE DID ANYWAY BEHIND MY BACK, WE HAD INTERCOURSE AUGUST 2021 AND SOON AS WE FINISHED I, THE WIFE BLOOD CLOTTED FOR 3 MONTHS!!!!!! THIS IS INSANE. I WENT TO GET TESTED AND FOUND OUT I HAVE A COMPROMISED IMMUNE SYSTEM, HYPO AND HYPER THERMIA, INFLAMMATION ON CERVICAL, CONGESTED LYMPHATIC, ON THE VERGE OF DIABETES, ON THE VERGE OF AUTOIMMUNE DISORDER, ON THE VERGE OF REYNAUD'S SYNDROME...   HOW IN THE HECK CAN YOU ALL SLEEP AT NIGHT...   THE SPIRIT WORLD IS COMING
pt recv vax 1DEC97 & that evening p/vax pt exp fever of 101, extremely sore rxn 3 inches below inj site;3DEC97 pt inj site edema & inability to lift arm;
10 days after shot pimples like bumps came up all over chest, stomach, arms, and few on thighs area. Went to ER due to possible infection of vaccine. 10/2/06 Received medical records from patient for hospitalization 8/12-8/13/06 with final Dx: reaction to small pox vaccine (pustular nonviral pustulosis vs eczema vaccinatum vs disseminated cowpox).  ID & DOD were consulted.  Photos were taken & mailed to DOD for diagnosis.  Patient was initially placed in strict isolation while hospitalized but DOD recommended not needed & patient was d/c home to be followed at AFB next day.
Experienced only a sore arm until "I" went to bed; "I" had heart palpitations that kept "me" awake; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history that she was aware of. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Apr2021 at 21:30, the patient experienced only a sore arm until she went to bed after the vaccination on Sunday, 25Apr2021 in the morning (as reported). Also, the patient had heart palpitations that kept her awake and feeling fine now on 26Apr2021 (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events experienced only a sore arm until, went to bed and had heart palpitations that kept her awake was resolved on 26Apr2021.  No follow-up attempts are possible. No further information is expected.
On-going shoulder and upper arm pain a year after the shot.  Have taken prednisone a couple times and pain stops for a short time but returns later.  Pain is not dibillating but does affect strength and ability to do tasks.
Information has been received from a licensed practical nurse and a consumer concerning a 12 year old male with atopic dermatitis on leg behind knee at time of vaccination and asthma, allergies and eczema who on 12-AUG-2008 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 660079/0331X), subcutaneous, left arm and on the same day received a dose of VAQTA inactivated in left deltoid. On 13-AUG-2008, the patient experienced redness, itching and swelling at the injection site. The patient may have also experienced fever and/or pain and burning while getting injected with the vaccine. On 15-AUG-2008, the patient recovered. The reporter has requested a lot check due the patients having adverse experiences. The patient sought medical attention by calling the office. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several patient provided by the same reporter. No additional information is expected.
5 cm x 5 cm area of erythema and induration on the lateral aspect of left thigh. Give BACTRIM and cephalexin.
pt recv vax;devel fever of 101;dec WBC count 4400,platelet count 74000;MD suspected sepsis;was irritable,subdued and had jaundice;nl bilirubin and dec WBC 43000 and all cell lines dec;was hosp;testing ruled out Epstein-Barr synd;
Reported chest palpitations  and chest pains and severe itching all over with shortness of breath and extreme body weakness.  temp  101.9.  Lot: EW0167   Advised to seek medical care immediately. She said she will follow up with her cardiologist, MD
22 month old female patient administered only diluent component of Pentacel, no AE; Initial information was received on 22-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 22 month old female patient (also reported as 23 month old female) who received only diluent component of Pentacel (product preparation issue), while she received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HEPATITIS A VACCINE (HEPATITIS A); PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 07-Jul-2020, the patient received a 0.5ml dose (Interval dosage : once) only diluent component of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ104AA and expiry date: 13-Oct-2020) (Injection) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent.  It was reported that nurse reported only diluent component of Pentacel was administered to 23 month old female.  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 and Module VI of the 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.
Bronchitis; coughing was so bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced no reaction. On 16Jun2021, the patient experienced bronchitis, coughing was so bad. she was not tested for Covid-19 at her urgent care visit. Reporter stated that, before the vaccine everything was fine. The patient had to go to the urgent care because the coughing was so bad and it was not really letting up at all. Patient was asking what she should do about her symptoms. Therapeutic measures were taken as a result of bronchitis, coughing was so bad. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-NOV-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-APR- 2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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.
Severe muscle pain in whole body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe muscle pain in whole body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Severe muscle pain in whole body). At the time of the report, MYALGIA (Severe muscle pain in whole body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated outcome of event  and updated Information of Second dose of vaccine.
Severe diahrrea, lightheadedness, headache, legs ached- started around 4:00 pm No treatment
Information has been received from a nurse concerning a 7 month old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 31-MAR-2017, at the age of 7 months, the patient was vaccinated, with the first dose of ROTATEQ, intramuscularly (dose, strength, frequency, lot# and expiration date were not provided), for prophylaxis. No adverse reactions were reported. Additional information has been requested.
Patient notified pharmacy the day after her vaccination that her arm was warm and a hard lump had formed. She did not believe it to be an allergic reaction. She presented to the pharmacy two days after the vaccination where it was determined she had received the vaccine lower and more posterior than the deltoid region where it should have been administered. The area was red. She had already presented to the doctor for a check up.
Pt receceived Hep B vaccine in L arm around 10:00 AM with no reactions. Pt stated 4-5 hours later he had a burning sensation in upper L arm that radiated to fingers with complaint of nausea. No vomiting, syncope, or external reactions noted.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient contracted shingles after the 1st shot, 1 week later the patient came down with shingles. The patient said that the shots did not help he/she any. No contact details were available.
This is a follow-up to report(s) previously submitted on 2/18/2008.  Information has been received from a physician and a licensed practival nurse concerning a 2 month old patient with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (Lot# 657386/0820U). Concomitant suspect vaccinations included ROTATEQ (Lot# 657671/0902U) administered by mouth. Other concomitant vaccinations included PEDIARIX (Lot# AC218125BB) administered intramuscularly in the left arm and a first dose of PREVNAR (Lot# 854014D) administered intramuscularly in the right arm.  There were no illnesses at the time of the vaccinations.   On 07-DEC-2007 the patient developed a localized reaction and a red mark at the injection site. The patient sought unspecified medical attention. No laboratory diagnostics were performed. No treatment was required. The patient sought unspecified medical attention.  No product quality complaint was involved. Additional information is not expected.