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 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:34 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). 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 77.31.  Concomitant products were not provided.  On 07-Jan-2021, Excursion time was 9 AM, temp was 34 and at 10 AM temp was 34; total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vials were moved to clinic. Vaccine BUD date was 27-Jan-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 Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were 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.
a day & 1/2 p/got fever, laryngitis, cold/saw MD 8PM 10FEB93 bronchitis (coroupy cough) started on ATB, cough syrup/decongestant; mom states pt had no fever until 10FEB93;
Developed urticaria, swelling of lips 6-8 hours after receiving vaccine. Denies wheezing or shortness of breath.
My daughter woke up the following morning with a swollen arm from her shoulder to the elbow the whole arm was red and tight and extreemly hot to the touch, she also had a fever that morning 103.2 and Tylenol was not helping any of these reactions/symptoms. I called the health Dept. that adminsterd the DTP shot that caused effects and the nurse who administerd it said that it would subside and improve with time and to continue to give her Tylenol. The next morning all symptoms were twice as bad and the red area continued to get more swollen and tight and moved further down her arm, the redness was not by any means normal and my daughter was in pain and un able to move the effected arm I am certain it was the DTP shot because the other Vaccine given that day was given in the oppisite arm and that arm was fine. My daughter had to be taken to the Emergency dept. where a Dr. treated her for a Infection caused by the DTP, (theese were his findings documented). She has been taking the prescribed medication for over 24 hrs and has not had improvement in the effected arm so if these symptoms proceed tomorrow morning 10/29/10 she will have to be taken back to the Emergency Dept. to have Fluid Drained from her arm.
Fever Nausea/Vomiting Cough Congestion Chest Pain  Headache Vaccine #1 22JAN2021 Vaccine #2 19FEB2021
Beginning 40 minutes after injection: 104.8 ° fever, complete loss of taste/smell , serious fever chills/shakes, body aches, heavy brain fog, fatigue (major). Above continued until 36 hours after shot then rapidly reduced over 20 minutes. Brain Fog and fatigue continued for 2 weeks, making work not possible. Fatigue diminished over 2-4 weeks, but brain fog continued throughout the summer until August.
Information has been received from an investigator concerning a 4 month old male child who received his second injection of Prevnar on 10/12/2000 as part of Prevnar post-marketing safety surveillance trial. The following day, the child was hospitalized for asthma. It was noted that the child "partially" recovered. Both the investigator and the medical monitor agree that this event was "possibly" related to vaccine administration. Follow-up info received on 01/25/2002 from the study investigator noted that the child was born prematurely, and had a history of asthma, bronchiolitis, and wheezing prior to vaccination. The child also received DTaP, IPV, HbOC and Hep B vaccines the same day as Prevnar vaccination. A diagnosis upon hospital discharge was "asthma and bronchiolitis with acute exacerbation." The child was treated with Albuterol, sodium chloride, and prednisolone. The investigator considered the events "possibly" related to the receipt of any of the vaccines. The medical monitor's assessment was unknown.
I was having a hard time hearing at dinner one night so I thought it was just the restaurant was noisy but, it still continued on for months and my hearing in my left ear was going out & also I don't have my monthly cycle anymore since I received the vaccine
The second dose of SHINGRIX was administered too early before it was due. The first dose was on 09/05/2018. Second dose was administered on 09/25/2018 in error.
Information has been received from a healthcare worker referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored M-M-R II (lot # J016234, expiration date: 19-APR-2016, strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Had lack of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Had lack of taste) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Had lack of taste). At the time of the report, AGEUSIA (Had lack of taste) 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.   Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
I had black spotting on both legs, and it is still not gone. It also itches and burns. I had low energy, dizziness, and tongue burning. I went to the doctor, and they gave me antibodies because they said it could be allergic reaction.
Pt vaccinated with Recombivax HB, subsequently, pt experienced a seizure disorder.  Additional info has been req'd.
Patient was admitted to Hospital  via the ER on 2/15/2022 in DKA with new onset type 1 diabetes.  Family first mentioned what in retrospect may have been early symptoms to me earlier at a younger brother's well visit on 1/28/2022 with abdominal pain and new onset bed wetting.  Presented to her well visit on 2/15/2022, labs done with visit showed glucose of 744 and directed to ER for further eval. Now followed by outpatient endocrinology clinic
48 hours after vaccine I had an episode of SVT lasting approximately 30+ minutes. Paramedics were called and they decided to take me to emergency room via ambulance due to 180 pulse lasting approximately 30+ minutes.
Patient experienced a brief episode of syncope immediately after receiving the Janssen Covid vaccine on 5/18/21 at approximately 1pm. Patient was seated at the time. Patient slumped over and was unresponsive for approximately 5 seconds. Patient resumed consciousness right away and blood pressure and respirations were checked by local paramedics. patient seemed alert and well when he left the store just after 1:30pm.
blood sugars have been out of control in the range of 400-500's; This is a spontaneous report from a contactable nurse reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EK9231/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 at 08:00 (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included insulin-dependent diabetes mellitus (IDDM)ongoing since an unknown date and thyroid cancer excised. The patient had a penicillin allergy and Nubain allergy. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EH9899/expiration date: not provided), via an unspecified route of administration, on 31Dec2020 at 04:15 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced her blood sugars have been out of control in the range of 400-500's. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included insulin lispro (HUMALOG), insulin glargine (LANTUS) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced blood sugars have been out of control in the range of 400-500's. The event blood sugars have been out of control in the range of 400-500's did not result in hospitalization. The patient received treatment for the event blood sugars have been out of control in the range of 400-500's included increasing the amount of insulin. The patient reported that on both occasions after receiving the vaccination, her blood sugars have been out of control in the range of 400-500's. She was doubling the amount of insulin with little ability to get her sugars within normal range. The outcome of the event blood blood sugars have been out of control in the range of 400-500's was unknown. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on a compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to event "blood sugars have been out of control in the range of 400-500's" in this insulin-dependent diabetes mellitus patient cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
24hrs after injection broke out in hives all over body-BENADRYL taken to relieve symptoms of itching
Day after vaccine given, pt noticed red, swollen area near injection site.  Phoned in for advise and told to ice, give Tylenol and call if rash worsens.  Was seen in clinic 2 days after receiving vaccine--had 11cm x 14cm indurated, red, swollen area to left upper outer arm.  There was also a cluster of vesicles 2cm x 3cm near injection site.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 21-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and included patient demographics. Additional information was received on 12-May-2009: product complaint investigation results.
Coughing after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing after 2nd shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing after 2nd shot). At the time of the report, COUGH (Coughing after 2nd shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
pt recv vax & exp a vaccine failure & devel chickenpox;a total of 7 patients from a daycare ctr were reported;
Pt. called today reporting itching rash on trunk and arms. No other symptoms. She suspects oral typhoid vaccine, rash started with pill #2, went away, then returned after pill #4 1-21-16. Taking BENADRYL and CLARITIN without relief. I recommended seeing a doctor. She is an ER nurse and will have one of the MD's look at it tonight.
Felt sick; Achy; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) and MYALGIA (Achy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (Felt sick) and MYALGIA (Achy). At the time of the report, MALAISE (Felt sick) and MYALGIA (Achy) outcome was unknown. Not Provided          Action taken with mRNA-1273 moderna vaccine was not applicable. Concomitant medication details was not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-091815 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091815:Crosse linked
About 12 hours after the 2nd vaccine, I woke with 102.7 fever, along with extreme chills, body-ache, splitting headache , nausea and dizziness.  The symptoms lasted for about 30 hours and then I felt pretty much back to normal.
81 year old male, no major medical history, presented approx 1 month after vaccine with mental and physical decline. At report time, pt was in what appeared to be late stages of dementia. Unable to maintain independent care, and was incoherent. Wife states that she and pt?s doctor blame vaccine.
Next day, periorbital edema. Lasted 1 week. Got second dose, and recurred, not as severe
Pt received vaccine 11/10/21. The evening of the next day he has pain on the tip of tongue. Its about an inch and red and rashy. He feels burning, pain and a little numb when it comes into contact with food or touch. Pt has not tried anything to help. Suggested OTC tylenol and ibuprofen. To consider salt water rinses or something cold to drink.
TELEPHONE CALL FROM A FAMILY FRIEND REPORTING CLIENT HAD RECEIVED A MENINGITIS SHOT YESTERDAY AND TODAY SHE WAS FAINTING AND HAVING PROBLEMS BREATHING.THE MOTHER WAS ALSO THERE AT THE RESIDENCE.INSTRUCTED CALLER TO CALL 911 NOW AND NOTIFY R.N. OF OUTCOME. Client seen Dr on 8-29-08 and was told she may have had a reaction to the HYDROCODONE she had been taking so he discountinued HYDROCODONE. The father of the client also states the breathing problems resolved after she stated using her asthma inhaler all symptoms now resolved.
Debilitating lower back pain beginning mid-morning on the day following the vaccine administration. It came on quite suddenly.  I left work early due to the pain. It feels like a deep twisting pain that seems to decrease strength in the back area.
69 year old male seen today with c/o or L upper arm and shoulder pain. Denies injury but noted worse symptoms after golfing 3 days post injection. Did have a Shingrix shot May 26th in L arm. C/O pain with movement.  L shoulder area with papules and 2 pustules. Mild erythema with swelling.
Small pox injection arm became infected with a red streak traveling under the armpit. Notices on 18 Apr 07. Given antibiotics to take.
Very severe nose bleeds that spontaneously occur and then stop. Feel light headed sometimes.  Blood will just start pouring out of nose all of a sudden. Happened after the first vaccine, second vaccine, and even more after the booster dose. Never had nose bleeds before. No major change in health, diet, or any injuries. Will be contacting doctor.
Runny nose, cough, some sleep difficulties, progressing into more coughing and then vomiting at bedtime.
Fatigue; Headache; Muscle pain; Nausea; Feeling unwell in general; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 24Mar2021 at 15:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was allergic to CEFTIN. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within the 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 11:00, the patient experienced fatigue, headache, muscle pain, nausea and feeling unwell in general. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the fatigue, headache, muscle pain, nausea and feeling unwell in general were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt states 1 week after her vaccine her arm became sore again, rashy, red and described pain in her elbow as tennis elbow.
That evening, I just became unconscious, fell to the floor, bled all over it and received several major contusions.
Swelling in arm, fever up to 39C, no appetite, decline and pain all over body, partial paralysis of face right side.
Local reaction to pneumococcal vaccine C/O (L) arm pain, warmth, and redness.
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 patients received Bivalent Boosters with 38 having improvement of symptoms of 50 percent or more).    Concomitant medication was not reported.  Vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received Bivalent Boosters with 38 having improvement of symptoms & 50 percent or more. Vaccine was given within current guidelines except seven were under 65. Patients were treated with skin lesions, brain, SBP 220, Tachycardia greater than or equal to 150 and body aches. Treatment medication was not reported.  This case contains information of 21st patient out of 42 reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Received H1N1 & Pneumonia vaccine 12 March 2010. Apparently developed fever that night & the following 2 days was "achy, dizzy & had nausea all day". On 12 Mar, complained of neck pain & dizziness, developed lethargy & then became unresponsive.
Chills 12/09/2021. . Vomiting and diarrhea on 12/10/2021
PATIENTS INITIAL COMPLAINT ON 6/8/19  WAS OF UPPER LEFT ARM PAIN AND  HEADHACHES  FROM IMMUNIZATION ADMINISTERED ON 5/31/19. THE PATIENT RETURNED ON 10/21/19 AND 10/28/19 TO STATE THE PAIN HAD NOT SUBSIDED, BUT HAD GOTTEN PROGRESSIVELY WORST ( NERVE AND NECK PAIN).
Injection site reaction, brought to the clinic 2 days post vaccination with varivax, Hepatitis A vaccine (Vaqta), and Comvax given in right thigh.  Pt has 4 cm area of redness  and induration, warm to touch at injection site. Injection given 7/3/06. Low grade temp (99.5) Instructed to give Motrin, use cool compresses and tea bags on site. To follow up if not better in the next 2-3 days.