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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 9:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:27 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.92.  Concomitant medication information was not provided by the reporter.  Vial was moved to clinic on 13-Jan-2021. Vaccine was moved to fridge on 09-Feb-2021. On 13-Feb-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Patient was first given the first dose of Pfizer at the Hospital.  He was told to go to Hospital on Feb 3, 2021 for the second dose.  He told them he needed the same medicine for the second dose.  He was told it didn't matter.   They gave him the maderna vaccine.  We called Hospital, and they didn't say much.   This is written by his daughter . I was not with my dad, dont know lot number, etc.
Burning pain numbness tingling pins and needles sensations Numb tongue and lips Sensations of bugs crawling all over body Muscle twitching Muscle spasms Shoulder blade pain Thigh pain
Pt experiences the same symptoms every time a vaccine is administered.  The symptoms are vomiting and diarrhea.  The first time he experienced these symptoms was when he was 3 months old and I rushed him to the hospital. The E.R. physician stated that he should drink Pedialyte for a couple of days.  At first I thought it was a virus, but after experiencing the same symptoms after every vaccination I was for sure he was having some kind of allergic reaction to the vaccine.
Client vaccinated 3/1/2021, approximately 3 days after vaccine client with c/o redness and skin warm to touch at injection site.  Redness increasing in size and still present 3/15/2021.  Client has MD appt today to r/o cellulitis.  Client had no other symptoms after receiving first dose of Covid 19 Pfizer vaccine.
Information has been received from a medical assistant referring to an 8 week old female patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored oral, ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported). No adverse effects were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
50 year old female patient reported significant rash on her back after receiving vaccine. Rash lasted several days.; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Pfizer sales representative.   A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. On an unspecified date patient experienced significant rash on her back after receiving vaccine and rash lasted several days. The outcome of the event was unknown .   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. Information on pertinent medical history and concurrent condition was not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, strength, lot # and expiry date not reported) for prophylaxis. Concomitant therapies included sterile diluent. The pharmacist reported that the patient received 2 doses of ZOSTAVAX, each dose on a different unspecified date (extra dose administered). No adverse effects reported. This is one of the 2 reports received from the same reporter. Additional information has been requested.
received two doses of GARDASIL 9 but never received the third dose; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On an unknown dates, the patient was vaccinated with the first and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient had not received the third dose (inappropriate schedule of product administration).
Received 2 vaccines yesterday 2/4/2019 on left arm, noted redness, swollen, painful in left arm 9 hrs  later. Mother applied ice today 2/5/2019, however redness has expanded from last night. Patient is eating ok, some tenderness, no pain on site. Patient has been more tired than usual but otherwise fine.
Patient stated no reaction for first 2 days. Then on 3rd day after vaccine patient had rash on arm by injections site. Then after 7 days giant welt formed at injection site along with 2" X5" rash at injection site.
Child had swelling and redness in left upper arm that began on 6/19/08 and DTap #4 was given in left upper arm on 6/18/08. Child treated with Bactrim suspension 7.5ml PO BID x 7days and given a follow-up appointment in 4 days.
About 10 minutes after giving flu vaccine, patient presented with red streaks on both arms and blotches around neck with generalized itching.  However patient was not in distress.  I gave her 50mg of Benadryl/Liquid checked her BP and HR 155/95 and 80bpm.  15 minutes later: 122/80 & 72bpm.  About this time MD was getting a prescription and I asked if he would look at her he felt she would be OK.  I had suggested the patient should get Benadryl and if symptoms return to take 25-50mg every 4-6 hours as needed.  MD told the patient the same thing.  I checked her BP 122/50, pulse 72.  Her red blotches and streaks were almost resolved before she left.  Patient said she was feeling better.  However after this occurred patient admitted that she had a mild reaction to a previous flu shot 2 years ago.  I told her she should not receive anymore flu shots without seeing a physician.  P.S. 12/04/2003: Called patient to get more info from her.  She informed me she had gone to the ER later on 11/20/2003 because she felt she couldn't swallow.  However they only gave her IV fluids according to patient no meds were given.  Symptoms resolved and she left 2 hours later.
May or may not be related, but I thought it was worth reporting in case there turns out to be a correlation that shortly after receiving my second Pfizer COVID vaccine, o failed a one-hour glucose test given during my 28th week of pregnancy. Other than being older than 30, I have no risk factors for gestational diabetes and am an otherwise healthy adult (good diet and physically fit). Due date is August 3rd. No gestational diabetes with previous pregnancy.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with VARIVAX lot # M046926 with expiration date of 28-NOV-2018, 0.5 ml, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). On 17-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information is not expected because there is no consent to contact the reporter. Sender's Comments: US-009507513-1708USA011918.
Headache, Myalgia, NauseaVomiting, headache; nausea; body aches; "just don't feel well" Narrative:  OTC Tylenol as needed  Other Relevant History:
Metallic taste immediately, dizzy, nausea, (lasted for about 15-20 minutes)
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-JUL-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Initial report was received 14 June 2011 from a health care professional. A child patient (age and date of birth not reported), had received an injection of PENTACEL (lot number, dose number, route, site and date of administration not reported) and an unspecified amount of time later, the child experienced a hypotonic episode. Outcome was not reported. No additional information was provided at the time of the report. Documents held by sender: None.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 3:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 3:23 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.20 for dose administered on 13-FEB-2021 and 69.29 for dose administered on 20-MAR-2021   No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion 13-FEB-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-JAN-2021 Batch number 031A21A underwent temperature excursion on 20-MAR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-MAR-2022 and beyond use date for the vial was reported as 08-APR -2021. Product moved to clinic on 20-MAR-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021 at 9:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 9:10 AM, 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 59.13 for dose administered on 21-Mar-2021.  No concomitant medications were reported.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM, 32 degree Fahrenheit at 10:00 AM and 34 degree Fahrenheit at 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Lump with chronic mild pain at base of lower rt lobe/ upper rt quad abd.  Just below ribs
dark coloration in urine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included unspecified drugs. The patient got the 1st dose of Covid 19 Vaccine yesterday and experienced side effects on 17Jan2021). The patient reported dark coloration in urine, but it's not blood and it's like dark coffee color or dark rust in color, slightly red, but the next morning it's gone. The patient was worrying and wanted to know more information. She also added, maybe it's just in the other medication that she is taking. The patient recovered from the event on 18Jan2021.  Information on the lot/batch number has been requested.
This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with ROTATEQ, oral, that had been improperly stored. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a physician via company representative refers to an unknown age female patient. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) injection (dose, route and location unspecified) for prevention of shingles. In May 2013, the patient experienced a "varicella-like" rash on her left arm after receiving ZOSTAVAX. The time between the onset of rash and administration of vaccine was unspecified. The patient had sought medical attention via physician appointment. No treatment was given for "varicella-like" rash. At the time of report, the outcome of the event was "improve on its own" as reported. Additional information has been requested.
No additional AE reported; HPB responsible for vacicnes reported a dose of PROQUAD was administered after temperature excursion; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JUL-2022, a temperature excursion (TE) occurred to measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) at 6 Fahrenheit (F) up to 14F (10F) for 1 hour and 8 minutes. On an unspecified date, TE occurred  to the same vaccine at 6F up to 14F (9.1 F) for 1 hour and 6 minutes. Then, on an unspecified date, a TE was reported again, at 5.7F for 30 minutes. On 29-AUG-2022, the patient was vaccinated with an improperly storage with measles, mumps, rubella and varicella (OKA-MERCK) virus vaccine live rHA (PROQUAD) (valid lot #W017570, expiration date: 29-NOV-2023) (strength, anatomical location, and route of administration were not provided) for prophylaxis.
I did not have an adverse reaction to the vaccine. I didn't feel good on 01/10/2023 with being extremely tired and muscles hurt. I tested positive for COVID-19 on 01/10/2023. I contacted the urgent care center and was prescribed PAXLOVID. I felt better with 3 days after starting the medication. I also took MUCINEX and FLONASE to help with my symptoms. As of today, I continue to have fatigue and just feel tired all the time.
Fever of 102.6 degrees - Tenderness injection site and enlarged axillary lymph node.
PATIENT STATED THAT SHE HAD A SORE ARM, THEN NECK AND SHOULDER, EVENTUALLY TO HIPS AND KNEES. PATIENT IS CURRENTLY ONLY IT IS CURRENTLY HAVING KNEE PROBLEMS.
began w/fever to 101.8 on 30JUL & persisted through 4AUG poor sleeping; progressively more irritable till seen on 3AUg; woke up probable early aseptic meningitis; unsure of related but community also exp death of baby 1 day p/vax;
On June 21, 2013, I received a shingles shot by a technician in the medical office of Dr. There was no screening and no physical exam to discern if I was well enough to get the shot. Within forty-eight hours, I became very ill and could not eat or drink. I was rushed to the emergency room. There, it was diagnosed that I had Bacterial Endocarditis ("B.E."), with resultant aortic murmur, severe aortic insufficiency by echocardiogram, and a splenic infarct 9 x 4 cm. I was shocked because this condition was until then, unknown to me. I was monitored in the cardiac intensive care unit for nine days, not sure if I would live. It has been the formal opinion of the attending infectious disease doctor and cardiologist that my body was trying to fight the B.E. They opined that the shingles shot overloaded my immune system and pushed me over the edge and exacerbated the B.E. to harm my heart. I have now asked the opinion of ten top internists regarding this issue. They all stated if they knew a patient had a fever, a heart murmur or B.E., that patient would be precluded from getting the vaccine. The problem is that presently, there is no protocol of a medical doctor screening required before the shot is administered. For instance, in my case, the doctor, if they had performed a physical exam, would have been likely to detect a fever, a heart murmur, etc. Therefore, I am extremely concerned, why Merck, as well as state and national regulatory agencies, allow the shot to be given without any medical work up including but not limited to a thorough physical exam. For instance, every time I see a drug store that offers the vaccine, I am very concerned about the dangers and resultant public safety issues regarding the non-existent physician screening for this vaccine, I am now aware of articles medical director of Merck personally wrote in that he helped promote having pharmacies give the shot, which doubled the amount of Merck vaccines sent out. Such a stance puts profits before the safety the public. Prior to this episode I had been in excellent health due to in large part, to an exceptionally healthy, non-processed fuel-centric diet, and regular exercise. Dr. had previously done an annual exam, on Nov. 26, 2012, with a written report stating due to my health practices, "the chance of a cardiac event is less than one percent in next ten years." He detected no murmur on exam and said did I not need an echo. Now due to the strep infection and the shingles vaccine, which significantly exacerbated overload of my immune system, I have subsequently been told by several cardiac surgeons that I need cardiac surgeon for aortic valve replacement else it will cause my death. I am currently being followed by a cardiac surgeon. Also, I must now see a cardiology and have frequent serial echoes and cardiology exam and told will need the cardiac surgery soon.