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 an 82-year-old female 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 3:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 3:34 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 82.79 for dose administered on 27 Oct 2021.  No concomitant medications were reported.  Batch number 035C21A underwent temperature excursion on 27 Oct 2021 with temperature range of 29 to 32 Degree Fahrenheit from 09:00 AM to 10:00 AM. These vials were moved to fridge on 29 Sep 2021 and 5 Oct 2021 and beyond use date for the vials was reported as 29 Oct 2021 and 4 Nov 2021 respectively. Product moved to clinic on 27 Oct 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   This case was linked to MOD-2022-566976 (Patient Link).
fever and associate shivering day after the injection. Sever incapacitating muscle spasm in left leg two days after ijection . Three weeks later second muscle spasm but not as sever. Discomfort in leg prsisted and diagnosed through ultra sound blood clot in left leg.
Not thinking clearly; she couldn't speak; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Not thinking clearly), SPEECH DISORDER (she couldn't speak) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 10-May-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 10-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced THINKING ABNORMAL (Not thinking clearly) and SPEECH DISORDER (she couldn't speak). At the time of the report, THINKING ABNORMAL (Not thinking clearly), SPEECH DISORDER (she couldn't speak) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: (Inconclusive) inconclusive.         No concomitant medication details was reported. No treatment medication was provided.
Have a Fever running all last night snd today of 100-101; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have a Fever running all last night snd today of 100-101) 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 PYREXIA (Have a Fever running all last night snd today of 100-101). At the time of the report, PYREXIA (Have a Fever running all last night snd today of 100-101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
swollen reddened heated area lt deltoid area 4 1/2" circumference;
Woke up with a swollen face about 54 to 60 hours after moderna covid booster vaccine.
Extreme fatigue and sleepiness, lack of motivation, brain fog and confusion, no appetite, stomach pain occasionally. I spoke to the Dr. over the phone and he advised I take OTC medication. About a month ago I had a bit of all the variants, I had 3 days of nausea, then 3 days of morning sickness, then 3 days of nausea. Dr. gave me anti nausea pills to get me through it. The next day I woke up and felt 20 again. Then recently I had muscle pain, headache and throwing up, etc.  I've lost a total of 100lbs due to no appetite due to the headache being so bad. Since having Covid in Nov 2020 I lost strength and motivation for months and months and it still happens.
Day of injection, local reactionw/swelling et redness.  Tuesday evening had H/A et took tylenol.  Woke Wednesday am et notices one bump above lt eye around eyebrow.  Later this day had another bump.  Thought something had bit her.  Woke Thursday morning with several bumps.  Went to dermatologist. Rx Valtrex tidx 7 days.  Now in eye et around eye et above in hairline.  Pain "5" on scale of 0-10 w/10 worse pain.  Tylenol every 4-6 hrs.  Will see Dr 2/15/07. This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been recieved from a health professional concerning a 72 year old female with no known medical history , or allergies who on 06-Feb-2007 at 10:30 was vaccinated subcutaneously with a forst dose of ZOSTAVAX vaccine (Merck) (lot # 656608/0032U). There was no illness at the time of vaccination. There was no concomitant medication. On the day of the injection the patient developed a local reaction with swelling and redness. That evening the patient developed a headache, and took some TYLENOL. When the patient awoke the following morning, 07 Feb 2007, shenoticed one bump over the left eye around the eyebrow. Later that same day she noticed another bump, and questioned if it was an insect bite. On 08 FEB 2007 the patient had several bumps, and was seen by a dermatologist and diagnosed with shingles. The patient was prescribed VALTREX TID X 7 days, bumps "now in eye and around eye, and up into the hairline. On an scale of one to ten, with ten being the worst pain, the patient was experiencing pain at a level five. The patient was seen by the doctor on 15 FEB 2007. The patient was considered recovered on 20 FEB 2007. There was no product quality complaint involved. No laboratory tests were performed. No further information is expected.
pt recvd vax; felt dizzy after sitting in waiting area;allergic to chickens,got shakey;paramedics started O2 + IV; to er;pt said chest felt heavy;given epi; dx poss anaphyletic rxn,prob anxiety attack;
Remained in vaccine clinic for 30 minute observation period after vaccine administration.  15 minutes after leaving clinic (45 minutes after vaccine administration), experienced flushing across chest, dizziness and nausea.  These symptoms persisted for two days and were significant enough that patient stayed in bed some of that time.  Patient reports no vomiting/diarrhea, no swelling, no respiratory issues.  She did not seek medical attention while experiencing the symptoms.  She reports she later consulted with her PCP about whether she should receive her second dose of Pfizer COVID vaccine.  She reports her doctor had reservations, but she was determined to get fully vaccinated, so her PCP renewed her epi pen prescription.  As of this writing, the patient has not yet received another dose of COVID vaccine.
Rapid heart rate of 91 two hours after receiving 1st dose of vaccine.; This is a spontaneous report from a contactable consumer (Patient) or other non-healthcare professional. A 70-year-old non-pregnant female patient received bnt162b2 (FIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, in Right Arm on 05Mar2021 at 11:00 (at the age of 70-year-old) as DOSE1, SINGLE for covid-19 immunisation. The patient medical history included drug hypersensitivity (Known allergies: Sulfa), high blood pressure and renal cancer stage iii (Verbatim: 3rd Stage Kidney Disease). The patient concomitant medications were not reported. The patient was not diagnosed with covid-19, prior vaccination and the patient had not been tested covid-19, post vaccination. The patient did not receive other vaccines within four weeks and did not receive other medications in two weeks of vaccination. On 05Mar2021 at11:00, the patient experienced rapid heart rate of 91 two hours after receiving 1st dose of vaccine. The Patient taken 5 mg Bystolic (a beta blocker) as a treatment. Therapeutic measures were taken as a result of rapid heart rate of 91 two hours after receiving 1st dose of vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered on an unspecified date.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Patient developed hives on chest, shoulder, and back about 15 minutes after receiving MMR vaccine on arm.
Headache day of and following day. The Wednesday following 3/31 elevated blood pressure, headache, dizziness, and neck pain. BP didn't come downfor 48 hours. Still running high needed to have a med added to current med. Also having chills no fever.
This is a spontaneous report from a contactable consumer. A 19-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in Left Arm on 27Jan2021 at 11:00, single for covid-19 immunisation. Medical history included tachycardia, irritable bowel syndrome, colitis, allergies to pineapple, dairy. Concomitant medication(s) included cobamamide (Vitamin B12 [cobamamide]), dicyclomine, escitalopram oxalate (lexapro). On 06Jan2021, the patient received first dose of bnt162b2 (Batch/Lot Number: EK5730) at Left arm. Facility type vaccine in Hospital. No other vaccine in four weeks. No COVID-19 tested post vaccination. No COVID-19 prior vaccination. On 27Jan2021 at 11:30 pm, the patient experienced dizziness, nausea, headache, chills, and diarrhea. The event assessed as non-serious. No treatment was received. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
Mother states: Child broke out in rash the afternoon after getting the 2nd dose of H1N1. Mom took child to Dr on 12-15-09. Was told by Dr. that rash was caused by H1N1.
pt recvd vax;10 mins later,exp what felt like muscle pull around rt shoulder & neck;MD noted pt c/o pain at base of neck radiating to rt shoulder;md assessment:myofascial pain cervical spine;md sees no physiological link b/w vax & sx;
Metallic taste in mouth lasted an hour, then bad sore throat, rhinorrhea, myalgias, fatigue and urticaria, few scattered red papules, lives alone, no one had similar sx, sx resolved 24-36 hours and then noted arm sore, was sl tired and achy but otherwise sx resolved.
Shots administered in A.M. 10/8/14. Child presented at clinic at 5PM with rash/fever. Mom gave TYLENOL at home.
Pain in lower ribcage.    Plus long-term continuing inflammation felt in lungs, primarily.  But also full body inflammation.
Pt received vaccine on 7/14/15. She came into the pharmacy 7/20/15 with a large red, itchy area 7 in x 5 in, she went to her doctor and received some steroid cream and an antihistamine. She will go back to the doctor if not improving. Will also ice the area.
Pt noted to have reddened warm local reaction about 6 inches in area on upper right arm. Daughter reports that pt got pneumonia vaccine previous day in physician's office in this arm. Please follow up for lot # and ? with physician's office. Treated with cold compresses for comfort.
Pt reported runny eyes, felt like a mass was in her throat, weakness. Pt. went to ER where she received "an IV with steroids".
Severe bilateral arm pain right greater than left, severe arthralgias, fever 101.9, headache, dizziness. Much more severe symptoms with booster than either other shot.
This spontaneous report as received from a pharmacy via a company representative, refers to 5 patients of unknown age and gender. No medical histories were provided. On unknown dates the patients were vaccinated with ZOSTAVAX (19400 PFU, subcutaneous injection, lot# J000433, exp date 10-APR-2014). No concomitant medications were reported. The pharmacist noted that out of the six recent doses administered there appeared to be a "higher than normal" number of localized, injection-site reactions. The severity was unspecified. All six doses, with five resulting is adverse reactions, came from the same box. The pharmacist had not stopped to use the lot in question. The outcome of localized injection site reactions was unknown. Additional information has been requested.
Vasovagal Reaction with Seizure like activity. Sent to Hospital by Ambulance.
pt recvd vax & devel rash on chest & waist; rash began as small red bumps & spread into large scaly patches which was itchy; pt taken to dermatologist;
The patient presented with pleuritic chest pain and shortness of breath. Was diagnosed with Acute Myopericarditis with a Cardiac MRI and Echocardiography. Was started on Colchicine and Ibuprofen. The patient was readmitted within 2 weeks with a large pericardial effusion with early tamponade physiology
This spontaneous report as received from a licensed practical nurse refers to an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2015, the patient was vaccinated with the dose of GARDASIL (lot # K014191; expiration date, dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
EXPERIENCED INTENSE ITCHING, STARTING ON THE PALMS OF HANDS AND SOLES OF FEET AND PROGRESSING THROUGHOUT ENTIRE BODY.  TOOK 2 BENADRYL TABLETS TO RELIEVE THOROUGHLY FRIGHTENING SYMPTOMS.  CONGESTION IN UPPER NASAL PASSAGES.
suspected vaccination failure; got them.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
There was NO adverse event.   Child received the third dose of vaccine in error.   Should have only had two doses in series.   Vaccine given on 05/22/21, 06/12/21 and 12/17/21.   Patient had a slight headache after each of the vaccine.   No other reactions.
This spontaneous report was received from a nurse refers to a 20-year-old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On an unknown date, the patient was vaccinated with PROQUAD (strength, dose, route of administration, lot #, expiration date were not reported) for prophylaxis instead of MMR II and VARIVAX. Concomitant therapies included STERILE DILUENT. The nurse confirmed that this event was a result of human error, not product confusion. No adverse event reported.
Fever, chills, vomiting, stomach pain, general pain and muscle pain, fatigue
This spontaneous report was received from the Vaccine Coordinator referring to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with doses of VARIVAX (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >5°F but < 14°F for 12 hours and 46 minutes and >14°F but < 46°F for 16 minutes. No adverse effects were reported.  There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009572: US-009507513-1701USA009570: US-009507513-1701USA009569: US-009507513-1701USA009571:
I received my third Moderna booster for COVID-19 on 9/13/2022. When I woke up on the morning of 9/14/2022, my eyes were nearly swollen shut. Both of my cheeks were also swollen, and the skin on my face was bright red. I went straight to the emergency room. My vitals were taken, and no anomalies were detected. I was given a dose of steroids, BENADRYL, and PEPCID. We waited for about 2 hours to make sure I didn't have an adverse reaction to the medicines, which I did not. I was then discharged and prescribed a 6-day regimen of methylprednisolone. I was also told that I could take OTC ZYRTEC and BENADRYL as needed. In the beginning, the changes weren't noticeable, but my symptoms gradually improved. My color is now better, and I occasionally have just a little bit of swelling. However, the longer I am up and about during the day, my face reddens a little and becomes slightly swollen. The swelling and redness aren't as severe as they were in the beginning, though. Also, prior to the incident, I hardly ever got up from my sleep to go to the bathroom, but ever since the incident took place, I have been getting up to go to the bathroom 2-3 times every night. When I was at the ER, I asked the doctor who treated me if she thought my symptoms were related to the shot I had just received. She said that she didn't think so, but I haven't experienced any other changes lately, so I don't know what else could have caused it. Although my symptoms have improved, I am anxious to see how I will fare after the medication regimen is completed.
tested positive for COVID-19/She sends herself to do Covid test and the result was positive; tested positive for COVID-19/She sends herself to do Covid test and the result was positive; sinus and ear infection; sinus and ear infection; bronchitis; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored.   This 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced tested positive for COVID-19/she sends herself to do COVID test and the result was positive, sinus and ear infection, bronchitis. The outcome of the events was unknown.  The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive in Apr2021.   The patient stated that she received the first dose of Pfizer COVID vaccine on 02Apr2021. She traveled to (state) and had sinus and ear infection while there and when she came back to see her doctor she tested positive for COVID-19 and bronchitis. Her symptoms started on 15Apr2021. Her physician told her that her quarantine period would end on 26Apr2021. She mentioned that she traveled and went back home last 20Apr2021. She sends herself to do Covid test and the result was positive. The 2nd dose schedule will be on 28Apr2021, which is more than 21 days.  She asked if it is okay to get the 2nd dose. She would like to know if she should get re-tested prior to receiving the second dose?  Information about lot/batch number has been requested.