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 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 9:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 9:34 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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 79.36 for dose administered on 02-Mar-2021.  No concomitant medications were reported.  Vial was moved to fridge on 24-Feb-2021. Product moved to clinic on 02-Mar-2021. Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit at 09:00 AM, 29 degrees Fahrenheit at 10:00 AM, 32 degrees Fahrenheit at 11:00 AM, 33 degrees Fahrenheit at 12:00 PM, 35 degrees Fahrenheit at 02:00 PM and 36 degrees Fahrenheit at 03:00 PM. Beyond use date for the vial was reported as 26-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 traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the third dose of GARDASIL (injection, dose and lot # were unknown). On an unknown date the patient suffered from fatigue and myalgia after receiving the third shot of GARDASIL. The outcome of events was unknown. Additional information has been requested.
Patient developed nausea and vomiting, weakness, tightness in throat, and itchy hives all over his body approximately 1.5 hours after receiving vaccine. He took 7-Up for his nausea. Patient called his doctor on 12/21/00 and was told if the hives persisted on 12/22/00 then he should call the doctor again. Patient stated the hives were gone as of 12/22/00.
Lungs congested; Trouble breathing; Trouble speaking/Trouble breathing; When she would speak she would cough hard; A spontaneous report was received from a consumer concerning a 65-year-old, female patient who received Moderna's COVID-19 Vaccine, and who experienced trouble breathing, trouble speaking, lungs congested and when she would speak she would cough hard.   The patient's medical history included back pain being treated by a pain management doctor, high blood pressure, high cholesterol, asthma and diabetes. Medications reported by the patient, within two weeks prior to the event, included albuterol inhaler.  On 18 Jan 2021, in the morning, the patient received their first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Jan 2021, in the evening on the same day of vaccination, the patient went to the ER (emergency room) due to trouble breathing and speaking, lungs congested, and cough when she would speak. While in the ER she had a blood test, chest x-ray, and an EKG which all came back normal. She stated that she did not think that the symptoms were related to an environmental change.   Treatment for the event included steroid and nebulizer treatment, and the symptoms resolved after treatment on the same day.   Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were resolved on 18 Jan 2021.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 028L20A), and who experienced the serious unlisted event of lungs congested, and the non-serious unlisted events of trouble breathing, trouble speaking, and cough.  The events occurred on the day of vaccination. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Pain in shoulder joint of arm where vaccine was administered immediately and decreased flexion, abduction, internal rotation.
Pt recvd 2 doses of Engerix-B & exp no rxn p/1st dose & w/in 8 hrs of 2nd inject devel arthralgia (arm became tender in the bone) & arthritic pain in the arm; MD visit was required to treat events; pt still c/o pain & arthralgia;
This spontaneous report was received from a 80 year old female patient referred to herself. The patient's current condition included penicillin allergy and blood pressure abnormal. No pertinent medical history. On 04-NOV-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified), single 0.65 ml shot, subcutaneous for the prevention of shingles. Concomitant medication included unspecified blood pressure medication. The reporter reported that "on 12-APR-2014 my back began to itch and now I can not lie on my back because it is to painful after I received the ZOSTAVAX vaccine 04-NOV-2013." The reporter also reported that "my physician confirmed on 16-APR-2014 that I have shingles." Patient was treated with VALTREX and DIPROLENE. "Blood work" was performed, results were not reported. The patient had sought medical attention by visiting physician. The patient's status was not recovered. Additional information has been requested.
Day 1 post vaccine - fatigue, sore arm, low grade fever, mild body aches Day 2 post vaccine - fatigue, sore arm, T Max 102.6, chills, significant body aches Day 3 post vaccine - confusion, seizure like activity, rigors, slurred speech, incontinence, periods of  ?lost time?  - ambulance ride to ER, ER doc said he can?t confirm a seizure because it was not witnessed and CT was negative but did endorse  a significant immune response to 3rd dose
mom appeared in clinic today & when asked if pt did okay w/vax reports rxn;states pt ran t103 for 24hrs despite receiving APAP;also states cried persistently for 5hrs;phoned MD but still was not seen;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, lot #, expiry date, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was vaccinated at an outpatient clinic with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 23-FEB-2013 as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-MAR-2015, the patient was treated at a health center for a painful rash that was diagnosed as a severe case of shingles. While shingles is an incurable viral condition, the patient was prescribed valacyclovir to manage his 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, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009595: US-009507513-1704USA009757: US-009507513-1704USA009812.
right upper arm swelling and itching noted 12 hours after injection. 4.5inx5in of erythema, warmth. No fluctuance or drainage from injection site. OTC treatment cold packs, hydrocortisone cream for itch, oral OTC benadryl if worsening itch. Monitor for signs of systemic allergic reaction or infection and follow up as needed.
Light-headedness, minor chest pain, in about 45 minutes after injection experienced extreme diziness.
MOTHER REPORTS MILD WEAKNESS TO LOWER HALF OF LEFT SIDE OF FACE FROM MOUTH TO JAW. ALSO REPORTS INCREASED TEARING OF LT EYE WITH MILD SWELLING. MOTHER STATES PLACED "REFRESH" DROPS ONTO LT EYE. MOTHER REPORTED TO CLINIC HDC WITH COMPLAINTS ON 7/15/2013 AT 10:00 AM. SENT TO CLINIC TO EVAL.
I woke up with tingling in my right hand and arm, my right side, and down my right leg. I went to the ER at Hospital, and was confirmed to have had a stroke in my left thalmus.
Severe pain in right hand after injection in right arm.  Throat tightening 2 hours post-vaccine.  Headache, dizziness, fatigue, slow mental response time x 48 hours after the vaccine was given (ongoing).  Facial swelling 60 hours post-vaccine.
Pt reported her ear-ringing (long-standing condition) was worsened after vaccine.
Initial misuse report received from a nurse on 14 October 2013. The over 65 year old patient had received FLUZONE ID. The safety and immunogenicity of FLUZONE ID have not been established in persons <18 or 65 and over years of age. If FLUZONE ID vaccine has been administered to an individual whose age falls outside the products indication, consider reimmunizing the persons with and influenza vaccine appropriate for the person's age or underlying condition. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
painful lump on my left collar bone; I have a painful lump on my left collar bone. My shot was in my left arm. It appeared a few days after the shot and over a week later it's still there and painful. It's about the size of a grape.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received first dose of COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 12 Feb  2021 13:45 as single dose for covid-19 immunisation. There was no medical history. Concomitant medications of patient included (other vaccine in two weeks) duloxetine hydrochloride (CYMBALTA), clonazepam (CLONAZEPAM). There was no other vaccine in four weeks. On 16 Feb 2021, patient experienced have a painful lump on my left collar bone. My shot was in my left arm. It appeared a few days after the shot and over a week later it's still there and painful. It's about the size of a grape. Patient did not receive any treatment. There was no covid prior vaccination and not tested for covid post vaccination. The outcome of event was recovering. Information on the Batch/Lot number has been requested.
Received Pfizer vaccines on 12/23, 1/18, 10/1/21 COVID-19 positive by PCR on 12/28/21 admitted to hospital on 1/8/22  for labor and delivery, delivered female infant on 1/8/22
The patient started experiencing an itchy throat and ears at 1045am. We then gave her one dose of 25mg benadryl.  After 5 minutes the patient started reporting more itchiness and she felt like she had some swelling happening so we gave her one more dose of 25mg benadryl. The patient starting feeling better and was talking to a coworker to ease her anxiety about it. At 1130am the patient said she was feeling back to normal and asked if she could leave, which we did allow her to leave after hearing her symptoms had gone away.
shortly after vaccination patient began to feel light headed and dizzy and became flushed and hot. Patient broke out in splotches over chest. Pt was given 25mg of diphenhydramine. Pt began to feel better after 30 minutes of observation .
diarrhea; severe abdominal cramping; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A 73-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EN6201; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in Arm Right on 26Feb2021 (73-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were reported as none. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: CL9264), via an unspecified route of administration on 05Feb2021 (73-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation and flu shot with which she had a bad reaction, extreme pain in her arm. The patient had not received any vaccine within four weeks. No additional vaccines were administered on same date of the Pfizer suspect. On 01Mar2021, the patient experienced diarrhea and severe abdominal cramping. The patient received the second dose of the vaccine and she had diarrhea. The patient wanted to know if this side effect was associated with the vaccine. The patient stated that the morning she was to receive the first dose of the vaccine, she took 2 regular strength Tylenol, to prevent side effects, because in the past with the flu shot she had a bad reaction, extreme pain in her arm. People told her that it's not recommended to take Tylenol before receiving the vaccine because that will make the injection not good. The patient wanted to know if this was true. She was nervous that by doing this she may not be protected from Covid-19. The patient received the second dose Friday 26Feb2021 at about 9 or 9:30 in the morning and then early Monday morning she had very severe abdominal cramping and after wards she went to the bathroom and had diarrhea in quick succession about 4 times. After that she felt like she was pretty much cleared out for the day and did not think too much about it but she was careful of what she ate, Tuesday she was fine, but Wednesday she had some diarrhea and this morning she had some diarrhea. The patient wanted to know if this was a side effect of the vaccine. The patient had one other question, she said like they say day late and a dollar short but with the first dose no one told her, she had a severe reaction to the flu shot with her arm took so she took 2 regular strength Tylenol before the COVID vaccine, no one told her not to do that. The patient wanted to know if Tylenol negate the vaccine. The patient had diarrhea earlier in the morning. It was ongoing but it was not severe and was off and on. The adverse events did not require a visit to emergency room or physician office. The outcome of the event diarrhea was not recovered while other event was unknown.   No follow-up attempts are possible. No further information is expected.
Lethargic, Sleepy: patient tried antihistamine drugs to relieve symptoms and has been resolved after 2 days.
8 days after vaccination, injection site became redenned, swollen, hot, painful, 2.5 inches circumference around injection site
This spontaneous report was received from a nurse and refers to a currently 18-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # R002344, expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA007952: US-009507513-1811USA007948: US-009507513-1811USA007949: US-009507513-1811USA007950: US-009507513-1811USA007951: US-009507513-1811USA001303: US-009507513-1811USA007945: US-009507513-1811USA007947.
Beginning about 9 hours after receiving the first dose of the vaccination (about 7:30 p.m.) I began feeling more energetic than usual.  The following day (Saturday, 8/14) and today (Sunday), I have felt like I was on crystal methane.  My energy level was extremely high, desire to eat was gone, I have only slept 7 hours in two nights, my mind was racing, and I had to keep moving. This feeling finally began to fade about 4:30 p.m. today. I am a recovering meth addict; I have been clean for 22 years. This was NOT fun.
The patient fell off  from the chair and laid on the floor with face down about 5 minutes after receiving Moderna Covid-19 vaccine. He gained conscious a few seconds later and asked for water. EMS staffs checked his vital signs about 10 mins later. His BP, oxygen saturation and EKG were normal. His friend picked him up about 45 mins.
Severe chills, body/joint aches, loss of appetite all started 8hrs after 2nd dose, lasting 36-48hrs in varying degrees. Loss of appetite x3 days. No fever, but felt like I was burning up. Profuse night sweats for 3 nites. Site injection pain, swelling, redness x3 days.
Patient started having sever flu like type symptoms (fever, diarrhea), and experienced shortness of breath.  resolved late 3-26-2022
Puffiness around eyes. Bags under eyes.  Some redness along bag lines under eyes.  Glassiness of eyes.
First dose COVID19 Pfizer (recv'd 3-04-2021) => slight soreness in upper arm; symptoms cleared in 24 hours Second dose COVID19 Pfizer (recv'd 3-25-2021) => no adverse reaction, no arm soreness Third dose COVID19 Pfizer - waited 15 minutes, then departed pharmacy.  Soreness in both arms, significantly greater in left arm.  Soreness in left arm continued to increase, significant around 6 PM.  About 10 hours after injection, began to experience chills followed by intense shivering/shakes.  Went to bed about 12 hours after injection where intense shivering/shakes continued under full winter blanket coverage (room temperature ~ 76 degrees F).  Shivering/shakes gone on waking.  After 46 hours, left arm soreness has resolved to stiffness, but still significantly greater than any right arm discomfort.
Missed period on May 2. On May 31 experiences heavy thick discharge but not menstruation. On June 22 experienced light bleeding for only two days. On July 21 period returned but lighter than normal.
C/O raised, red, dime-sized areas appear to be swollen that itch on arms bilaterally from shoulder to wrist.  A few appeared day after shots given and now have approx 30.  No heat, no s/s anaphylactic reaction, slight fever (mother unsure of exact temp on mother gave antihistamine and still itching the day following vaccinations No change in diet or contact with substance that may have caused reaction.  No history egg allergy or reaction to vaccines in past.  Child taken to ER 10/7/13 given cortisone cream (unsure name) BID x 14 days to apply to arms, Benadryl every 4 hours prn for itching.  Was told by attending health provider (unsure of name) that condition did not relate to immunizations but ruled out everything else.
Chills; Body ache; Fever; I''ve been sick, I just feel so sick; Cold; Runny nose; Sore throat; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Tired"; CHILLS (non-serious) with onset 18Nov2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "Body ache"; PYREXIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "Fever"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "I''ve been sick, I just feel so sick"; NASOPHARYNGITIS (non-serious) with onset Nov2021, outcome "unknown", described as "Cold"; RHINORRHOEA (non-serious) with onset Nov2021, outcome "unknown", described as "Runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Sore throat". Additional information: Patient don't know where have it and where to put it. Patient was in bed and just feel so sick." Patient asked whether these were normal side effects or should patient need to go doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a fever of 101.0 for about 2 days but that was it I never felt really bad I had been in an area with lots of people, so I took a self-test and COVID-19 Test came back positive. Then I went to the Clinic to get another test done to confirm me at home self-COVID-19 Test. This test was positive as well.  Then I contacted my doctor, and I was told since I was 71, she said to take the infusions over medication by mouth this was through a Televideo. I went and got the infusion on 9/30.  I never really felt bad I just got them injections because that's what my doctor said. I kept testing positive for the next few weeks and then week 3 I had a negative reading COVID-19 .My temperature also went back to normal.
Patient inadvertently received a 2nd dose of Prevnar20 his first being sometime in April. Patient only complained of redness and soreness at the injection site that has since resolved.