chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients were administered vaccines from a vial that has been punctured for greater than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered vaccines from a vial that has been punctured for greater than 12 hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 939906) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered vaccines from a vial that has been punctured for greater than 12 hours). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered vaccines from a vial that has been punctured for greater than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. No adverse event reported.  It was reported that doses were administered the same vial which was initially punctured on 26-Oct-2021.
Patient reported that he was fine for several days after receiving the vaccine, but after the weekend he developed persistent nose bleeding, which he said has not stopped and is also producing chunky clots of blood. He did not report any other symptoms, and was advised to contact his doctor if the bleeding continues.
Rash on the back of injection arm and on leg.  Fever, chills, and aches.
One week to the day after my second shot, overnight I came down with a sore throat which turned into chest congestion, coughing, sinus discharge (green) tightness of my chest. This came on extremely fast. I had to take 2 days off work. I saw my family physician, who sent me for chest X-rays. Came back negative for COVID, but showed signs of Bronchitis. I have been subject to sinus infections, but have not had any issues in over 5 years. I have never had issues with Bronchitis. My Family doctor prescribed Prednisone  & Levaquin. One round did not take of the issue. I received a second round of both. It has not cleared up my coughing/congestion. I still have a sinus discharge (green) infection to date.
Information has been received from a health professional concerning a 77 old female who was vaccinated with two doses of pneumococcal 23v polysaccharide vaccine one in 1996 and one on 10/19/05 (lot # 650453/0791P), respectively. On approximately 10/19/05, the patient complained of swelling and 8 inch area in diameter, warm to touch at injection site. The patient was given methylprednisolone sodium succinate injection and oral prednisone. There was no product quality complaint involved. The patient's events were considered to be other important medical events by the reporter (OMIC). Additional information has been requested.
Chills occurred 12 hours after the shot.   Never have had a reaction to the flu vaccine before.    Why I'm reporting this is that these chills were exactly what occurred after I got the second shot of the Moderna vaccine in late February.     Wonder why the onset (exactly 12 hours after the flu shot) occurred exactly on the same time frame as my Moderna vaccine (chills happened exactly 12 hours after that vaccine was given).   And the symptoms of both the flu shot and the Moderna were identical (chills).    The only difference is that the Moderna chills lasted 24 hours; the flu shot chills lasted 4 hours.        Is there some interaction between Moderna vaccine and the flu shot that we don't know about????
Patient had her Flu and Pneumonia shots on Friday 11/12/10 she came into the pharmacy on Sunday 11/14/10. Her arm was red and swollen below the injection site down to her elbow. Patient complains of pain as well, which she states, started the evening of her immunization. She was seen by her Dr.
On 4/27/02 patient developed pain in right arm; zoster-like rash developed next day. Admitted to hospital on 4/30/02 with aseptic meningitis Treated with IV acyclovir with rapid improvement.
blisters have dried; blisters have dried; rash on left side of med-section; first dose and second dose, developed shingles; shingles; skin became painful to the touch; pain/pain is much better but not completely gone; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had a case of shingles on 28th December 2018 on her left face and neck area).   On 14th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2022, 860 days after receiving Shingrix and 924 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin tenderness and pain. On 29th July 2022, the patient experienced rash. On an unknown date, the patient experienced scab and blister. The patient was treated with gabapentin and antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the vaccination failure, shingles, skin tenderness and rash were unknown and the outcome of the scab, blister and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, scab, blister, skin tenderness, pain and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's comments: The reporter was the patient herself who reported that she had received her Shingrix in the left arm. The patient developed shingles on her left mid-side on 22nd July 2022. On 22nd July 2022, her skin had became painful to the touch. On 29th July 2022 she had developed the rash on the left side of her med-section. She had a video conference on 30th July 2022 with an urgent care Medicine of Doctorate (MD). The MD had started her on an anti-viral for 7 days. The patient had then spoken to her regular MD on 5th August 2022 and was given gabapentin for the pain. The blisters had dried and the pain was much better but not had completely gone. The Healthcare Professional (HCP) did not consented to follow-up, however the patient was fine to be contacted to her. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
headache; Lightheaded/dizzy; Elevated SBP 190's, monitored for additional 15min SBP greater than 200; This is a spontaneous report from a contactable Nurse reported for herself. A 61-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EJ1686), via an unspecified route in the left arm on 03Feb2021 at 08:00 (age at vaccination: 61-year-old), as a single dose for covid-19 immunization. Medical history included breast CA, cerebrovascular accident (CVA), migraines, osteopenia, insomnia, hypertension (HTN)-new and known allergies with Levaquin, latex, metoclopramide, ondansetron, clarithromycin, statins, Zyvox and Ambien and penicillin (PCN). Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), alprazolam (XANAX), pitavastatin calcium (LIVALO), temazepam and Vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 03Feb2021 at 08:00 after 15 min, patient developed headache, upon standing became lightheaded and dizzy with Elevated SBP 190's, monitored for additional 15min SBP greater than 200. Patient was taken to Emergency Room. Since that time have had headaches, lightheadedness, dizziness and have had elevated BP since this time. Now diagnosed with high blood pressure - new diagnosis and on HTN medications. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures taken as a result of the events included emergency room: IVF labs, F/U with primary care physician for further management. The patient underwent lab test and procedure which included blood pressure elevated SBP 190's and SBP greater than 200 on 03Feb2021; post vaccination antibodies test: SARS-CoV-2 Nasal Swab: Negative on 23Feb2021; SARS-CoV-2 Interp Nasal Swab: Negative on 23Feb2021; SARS-CoV-2 Nasal Swab: Negative on 08Mar2021 and SARS-CoV-2 Interp Nasal Swab: Negative on 08Mar2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
No adverse affects reported; improperly stored VARIVAX was administered to patient on 5/1/2020; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.       On 01-MAY-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S012036 with expiration date 17-APR-2021; dose, frequency and route were not reported) for prophylaxis (product storage error). No adverse affects were reported.  The temperature excursion was 48.2 F for 4 hours. There was not previous temperature excursion. Data logger was involved.
In March of 2023, I noticed I had dry skin and itching. I spoke with doctor, and I got a steroid. It did not help. I then began to have blisters. I had body aches, also. The blood work came back, and my creatinine was elevated. I saw a pathologist and a nephrologist, and I I was diagnosed with bullous pemphigoid, a rare auto immune disease. I received a shot, and the rash has healed almost completely.
breakthrough Covid infection; breakthrough Covid infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (115193).  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2021, outcome "recovered" (2021) and all described as "breakthrough Covid infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Oct2021) positive. Clinical course: the patient received her second Pfizer shot about three weeks before returning to high school for her sophomore year. Around the beginning of October, she experienced a breakthrough Covid infection. Contact tracing could find nobody she had been around with a positive test. Everyone was fully masked in the schools here, so it was a mystery where she picked it up. She had mild symptoms and quarantined in her bedroom for 10 days. She was fine now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swollen around mouth; Tingly around mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (swollen around mouth) and PARAESTHESIA ORAL (Tingly around mouth) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     Concomitant products included CALCIUM and VITAMINS NOS for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MOUTH SWELLING (swollen around mouth) and PARAESTHESIA ORAL (Tingly around mouth). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and LORATADINE (CLARITINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOUTH SWELLING (swollen around mouth) and PARAESTHESIA ORAL (Tingly around mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications include unspecified cosmetic facial fillers.
Immediately after this vaccination I was very sick for about 6 days.  Even though my symptoms were normal known side effects, they were so extreme that I was bed ridden for most of the time. Then 5 weeks after this vaccination I was sick with some type of viral illness. Several days into this illness, on May 19th, I suddenly had shortness of breath. The next day, May 20th,  it was worse so  I went to my doctor's office, where they gave me a rapid covid test (negative) and an inhaler. I'm very concerned because I have not needed an inhaler for about 15 years. I'm reporting this in case there is a link to the vaccine.
sudden onset of hair loss within two weeks of this dose. This hair loss included the hair on my head, eyebrows, and other body hair.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18May2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number:EW0164,, administration time:10:00 AM, dose number:1, vaccine location:Right arm}]), administration date: 23Apr2021, when the patient was 52 years old, for COVID-19 immunization.  The following information was reported: ALOPECIA (non-serious) with onset 31May2021 16:00, outcome "recovered with sequelae", described as "sudden onset of hair loss within two weeks of this dose. This hair loss included the hair on my head, eyebrows, and other body hair.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: No other vaccine in four weeks. No covid prior to vaccination. Covid tested post vaccination. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After shots given pt. was fine and left exam room. About 5min later he had dizziness, nausea, and faint. He fell without injury or loss of consciousness. Had a few scratches on hand from falling. After vomiting he felt better blood pressure 110/72 pulse 62 before going home no further symptoms observed per nurse.
pt inadvertently recv an adult dose of Havrix on 24FEB97 uneventfully;
Vomiting, Diarrhea, Neck crink all reported 6/11/21. Note vaccine administration date.
Case number PHEH2014US013447, is an initial spontaneous report received from a nurse on 27 Jun 2014, with a follow up received from nurse on 23 Jul 2014 and with a follow up information received from the physician on 04 Aug 2014. This report refers to a male patient of unknown age. His medical history and concomitant medications were not reported. He received an initial dose of Men CYW-135 liquid conjugate component of MENVEO (batch number: M13054) intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 27 Jun 2014. No adverse event was reported following this administration error. Upon follow up received from the physician, it was reported that they would re-immune the patient with correct preparation. Non-significant follow up received from nurse on 23 Jul 2014: updated physician contact information and reporter comment (the nurse stated that she would give the follow up form to doctor to fill out. They would have to figure out who was the patient and then would fill out the follow up form). Follow up information received from the physician via 04 Aug 2014: Updated patient demographics (initials and gender) and physician comments.
Heart pulse skipping beats; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 10:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease stage 3, hypothyroidism and penicillin allergy. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 24Feb2021 at 12:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 12:45, the patient experienced heart pulse skipping beats. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event heart pulse skipping beats was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on an unknown date, refer case US2019GSK065385). On 2nd April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced headache, feeling hot, muscle pain, shivering and pain. On an unknown date, the outcome of the headache, feeling hot, muscle pain, shivering and pain were not recovered/not resolved. It was unknown if the reporter considered the headache, feeling hot, muscle pain, shivering and pain to be related to SHINGRIX. Additional details were provided as follows: The patient had a pounding headache, feel feverish, muscle aches, shivering and achy. The patient wanted to know should she be concerned about these symptoms as did not experience after 1st dose of SHINGRIX. The patient reported she would monitor it and if she saw no improvement would contact her physician.
patient received 3 doses of Shingrix.  He received doses on Feb 2, 2019; Aug 13, 2019 and today Nov 25, 2019. no reaction so far, BUT it does exceed ACIP recommendations and package insert.
Acute right thigh pain and fever after receiving the PPSV23 vaccine on Friday. Symptoms began shortly after the injection. The pain at injection site on right thigh was gradual and became worse until patient could no longer bear weight. He also began having low grade fever which became worse. This morning, patient said he could not move and had a fever at 103F.
Patient went to an urgent care with red and painful injection site. She was diagnosed with cellulitis and given oral abx. She followed up two day later with swelling pain and erythematous 10x6 cm. Patient was advised by urgent care to go to ER for IV antibiotic. Patient was called by urgent care the next day for a follow up and patient stated she was better.
Information has been received from a licensed practical nurse concerning a 5 year old female who on 7/16/99 at 12:00 PM was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot # 628697/1838H). On 5/10/04, the patient developed less than 50 lesions. Subsequently, the patient recovered. There were no adverse events following prior vaccinations of the patient or her siblings. No further information is expected.
was due for IPV and DTaP vaccines, and was inadvertently administered a dose of Kinrix; 9 Months old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Vaxelis (1st dose received on an unknown date) and Vaxelis (2nd dose received on an unknown date).   On 30th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comments: The patient was due for IPV and DTaP vaccines and was inadvertently administered a dose of Kinrix. The nurse stated that she monitored the patient for an additional 15 minutes after the dose and no issues were noted. The reporter spoke with the patient's family on the day of reporting and the child (patient) was doing well. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient inadvertently administered a dose of Kinrix instead of IPV and DTaP vaccines below the recommended age limit, which led to wrong vaccine administered and inappropriate age at vaccine administration.