chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021; patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2022 at 3:54 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Feb-2022 at 3:54 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The reporter was mentioned as EMT. It was reported series of patients approximately 540 patient received lot number past its 30 day expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on about 20 Dec 2021. This vaccine was administered up until its manufacturing expiry date of 04 APR 2022. The patient received it on 12 Feb 2022 15:54:46. We no longer possess this lot number. Treatment medications were not reported.
Menstrual period arrived 9 days early, have been bleeding for 17 days straight; Menstrual period arrived 9 days early; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 22Sep2021 (Batch/Lot Number: FF2589) as dose 1, single for COVID-19 immunization in a hospital. Medical history included COVID-19 from an unknown date (COVID prior vaccination: Yes). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took guaifenesin and experienced drug allergy. Since the vaccination, the patient has not been tested for COVID-19. On 06Oct2021, it was reported that the patient experienced menstrual period arrived 9 days early, have been bleeding for 17 days straight with no signs of it letting up. No treatment was received. The reporter considered the events as non-serious. The events did not result in death or life threatening condition, caused/prolonged hospitalization, disability or congenital anomaly/birth defect. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
I was having either a sinus infection or allergies when receiving these vaccines. Since the vaccines I have had constant water/ congestion in my ears. It has been with me since the last vaccine in April, 2021
4 days post vax pts face and eyes swollen, bumps all over body within 20 minutes after. Pt treated with Tylenol and Benadryl. Pt felt ill, slept fine, rash described as prickly head, pt breathing fine.
rash; the patient was in contact with plants and developed dermatitis to contact; This case was reported by a physician via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced rash and contact dermatitis. On an unknown date, the outcome of the rash and contact dermatitis were unknown.   It was unknown if the reporter considered the rash and contact dermatitis to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The physician reported that the patient received Shingrix on Saturday, 5th September 2020 and experienced dermatitis and rash. The physician related the adverse event as the patient was in contact with plants and developed dermatitis to contact, which led to contact dermatitis No further information provided. The reporter has consented to follow up.
This form does not allow for the report I am trying to make, and I think this report is essential to your data-gathering.  I want to report that I had Guillain Barré syndrome in 1966 at the age of 10.  There has been alot of concern in the press and social media about history of GBS and the Covid vaccine.  I want to stand up and be counted as a person with a history of GBS who had no significant side effects from the Pfizer Covid vaccine.
Syringe started leaking about 0.2 - 0.3 ml; Syringe started leaking about 0.2 - 0.3 ml; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of UNDERDOSE (Syringe started leaking about 0.2 - 0.3 ml) and DEVICE CONNECTION ISSUE (Syringe started leaking about 0.2 - 0.3 ml) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported.).    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced UNDERDOSE (Syringe started leaking about 0.2 - 0.3 ml) and DEVICE CONNECTION ISSUE (Syringe started leaking about 0.2 - 0.3 ml). At the time of the report, UNDERDOSE (Syringe started leaking about 0.2 - 0.3 ml) and DEVICE CONNECTION ISSUE (Syringe started leaking about 0.2 - 0.3 ml) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.  Action taken with the drug in response to events was not applicable.
6/21: mild arm soreness, afebrile, asymptomatic. 6/22 PM: softball-sized inflammation, warm/hard to the touch, painful, afebrile. 6/25: swelling had gone down, but a bruise and some numbness was developing at injection site. about a golf-ball sized area inflamed, red and warm to the touch; much less pain than before, not getting any worse.
Nausea; Headache; Dizziness; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 11Jan2021 (19:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included sulfa allergy and penicillin (PCN) allergy. The patient's concomitant medications were not reported. The patient had previously received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) for COVID-19 immunization. On 12Jan2021 (11:00), the patient had nausea, headache and dizziness. The patient did not receive any treatment for the reported events. The outcome of the events, 'nausea', 'headache' and 'dizziness', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Adverse event included ~24hours of chills and body aches. Temperature not taken but no fever to touch. 28 weeks pregnant at the time of vaccination, due date is 4/2/2021. No pregnancy complications at this time.
3 incidents throughout the day of arrhythmia.  Lasting til I was laying down and relaxing and taking deep breaths.
This case was reported by a healthcare professional and described the occurrence of pain in a female subject aged 30 - 40's who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 9 October 2007 the subject received 1st dose of Fluarix 0.5 ml in the right arm.  On 9 October 2007, at an unspecified time after vaccination with Fluarix, the subject experienced pain.  At the time of reporting the outcome of the event was unspecified.  This event occurred in five different female subjects.
About 1 minute after receiving the vaccine patient reported dizziness and "feeling funny", she alerted nursing who then called the PA to evaluate. Patient RR and HR stable however, BP was elevated on initial read at 192/139 (L arm) then repeated on opposite arm with 216/136. Patient stated that she did not take her antihypertensive medications this AM (lisinopril) in addition to the day before. After five minutes, repeated blood pressure at 199/118- she denied any symptoms other than dizziness and possibly some nausea. Patient was transported to the ED by wheelchair
24JUN92 seen in ER devel rash; 22JUN92 across midsection front & back rash; multiple raised lesions entire abdomen & low back; itchy; 26JUN92 rash spreading to upper thighs/groin/axillae conts on abdo/breast/lower back; meds given;
Headache, Myalgia, Fever, Rhinorrhea, fatigue, chills. Narrative:  Temp was up to 99.6.
Tinnitus - sounds like sizzling or insects; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8728 or ER8729) via an unspecified route of administration in the right arm on 09Apr2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient had no known allergies. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208 or CN6208) via an unspecified route of administration in the right arm on 18Mar2021 at 09:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced tinnitus - sounded like sizzling or insects. 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 event. The clinical outcome of the event tinnitus - sounded like sizzling or insects was not recovered.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 05-AUG-2016, the patient was vaccinated with a dose of PROQUAD (lot # M006105, expiration date: 01-AUG-2014) (dose, frequency and route were not provided) and with a dose of VARIVAX (lot # L048465, expiration date: 02-DEC-2017) (dose, frequency and route were not provided). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 12 month old white female patient who on 6/29/04 at 10:15 AM was vaccinated SC once with a 0.5ml first dose of varicella virus vaccine live (lot # 648042/1344N). Concomitant vaccine administered at 10:15 AM on the same day 6/29/04, included a SC first dose of MMR (lot # 646886/0949N). On 7/1/04, in the AM, the patient developed vesicles on her hands and she was taken to the physician's office for examination. It was noted that the patient had four lesions on each hand and more lesions continued to appear on her abdomen and trunk while she was in the office. The physician diagnosed her with a mild case of varicella. There was no fever. No treatment was required. It was noted that therapy was not discontinued. There was no product quality complaint reported. Follow up information received from a registered nurse reported that the patient recovered. No additional information is expected.
High blood pressure; This is a spontaneous report from a contactable consumer (patient himself).  A 75-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via unspecified route in left arm on 04Mar2021 as single dose for COVID-19 immunization. The patient medical history included High Cholesterol. The patient concomitant medication included Atorvastatin (LIPOTOR) received within 2 weeks of vaccination. The patient medical history included prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested positive for COVID-19 since the vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EP6955 and expiration date was not reported), via unspecified route in left arm on 12Feb2021 at 10:00 as single dose for COVID-19 immunization. On 05Mar2021 patient had to take him to the emergency room with an unexplained high blood pressure of 220/106 pulse rate 100. It came down to 170/90 and was given a blood pressure medication. Two days later we had to make another emergency room visit with the same pressure readings. the blood pressure medication was doubled. a week later a third emergency room visit with the same pressure readings. For a person with no history of blood pressure this was baffling. Saw an article about an doctor with the same symptoms and decided to record it. The patient had Allergies to medication included Penicillin and he received as treatment Beta blockers for blood pressure. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Fast Heart Rate and light headed 10 minutes after receiving the injection and lasted around 5 minutes.
Patient came to pharmacy on 11-1 with 2 inch diameter bruise at injection site. He stated that he was going to let MD look at it.
Started out with chills and slight headache about 10 hours after vaccine.  Chills went away after about 5 hours.  Later in the night started experiencing nausea and temp of 101 . Continued all next day and couldn't stay awake over 10  minutes.  Slept pretty much 24+ hours and did not get out of  bed or eat.  Again nausea through the night and a little headache.  24 hours after vaccine felt a little tired but was able to get up and eat.  Now my arm is swollen and has rash.
Moderate muscle/bone/joint ache/pain. Nausea. Dizziness. Moderate pain at injection site. Headache.
pt recv vax; devel alopecia;neg hx of alopecia in the family;
Patient had a fever approximately 100.5 fatigue flu like symptoms headache muscle pain nausea.
Pt was given a 2nd booster dose of Moderna, so he has now had 4 doses total. No symptoms as of 1/12/22. Pt aware.
Temp of 102.2, achy, chills.  Fever lasted all day the day after vaccination.  Fever was gone the following day.
Patient's left arm was red and swollen. I recommend take acetaminophen or ibuprofen for the pain. I also recommend use over the counter hydrocortisone cream for the redness. I told patient to let her primary doctor know regarding the adverse event.
agonizing pain in shoulder that started 4 days after Moderna monovalent booster injection; pain has improved over time per patient however patient states she continues to have discomfort when trying to move arm/shoulder up
whole arm is swollen; warm to touch; incredibly itchy; can see the redness; Rash at the site of the injection; A spontaneous report was received from a consumer report] concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a rash at the site of injection/injection site rash, swollen arm/peripheral swelling, warm to touch/skin warm, incredibly itchy/pruritus, and redness/erythema  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 18 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient developed a rash at the injection site, her arm was swollen, warm to the touch, itchy, and red on an unknown date.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events rash at the injection site, arm was swollen, warm to the touch, itchy, and red were not reported.  Reporter causality for the events was not provided.
Two months later (12/21) began symptoms of myasthenia gravis and diagnosed in March of 2022.  Seeing a neurologist at facility for treatment which consists of high dose of prednisone, Imuran, and pyridostigmine.  Incidence of MG is 7 out of 1 million and cannot be ruled out as associated with the 3 vaccines I received.  I have since received a 2nd booster because I am immunocompromised.
Low fever, chills, malaise, headache, severe pain at injection site (inability to move arm, lay on arm or press on it without 7 out of 10 pain). Pain in arm began at 1300 hrs on 3/17, fever noticed at 500 hours on 3/18.
Nausea; Headache; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via unspecified route of administration in the right arm on 25Mar2021 at 13:15(at the age of 52-years-old) for COVID-19 immunisation. Medical history of the patient included ovarian cyst and there were no known allergies. The concomitant medications included medroxyprogesterone (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), vitamin c (MANUFACTURER UNKNOWN) and Zinc (MANUFACTURER UNKNOWN) all taken for unknown indications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 25Mar2021 at 20:00, the patient experienced headache and fatigue on evening of injection (8 hours after), continued headache and acute nausea on the following morning (26Mar2021). Mild headache and mild nausea continued 24 hrs after. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue and nausea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
PATIENT DESCRIBED MOUTH AREA FEELS NUMB AND WAS SWOLLEN.  PATIENT WAS INJECTED BENADRYL 50MG INTRAMUSCULARLY. SHE WAS REVISITED AND AFTER 30 MINUTES, MOUTH HAD DECREASED SWELLING.
felt like  they had the flu; not felt good; Really Bad Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received the 2nd dose of Shingrix. On 9th August 2019, less than a day after receiving Shingrix, the patient experienced headache. In August 2019, the patient experienced influenza like illness and feeling bad. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the influenza like illness and feeling bad were unknown.   It was unknown if the reporter considered the headache, influenza like illness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. On the last Friday (from the reporting date), the patient received 2nd dose of Shingrix and was not felt good since.  For the first 48 hours after the vaccine,  the patient had a really bad headache and felt like  having flu. The patient did not consent to follow-up. All information was collected via chat and no contact information provided when requested.
This case was reported by a pharmacist and described the occurrence of arm pain at injection site in about nine to ten subjects of unspecified age and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). On unspecified dates in 2013 the subjects received a dose of FLULAVAL (unknown). At unspecified times after vaccination with FLULAVAL, the subjects experienced arm pain at injection site, described as local reactions of "arm pain, arm soreness, stinging at injection site and stinging at the time of the injection". At the time of reporting the events were unresolved. The pharmacist reported about nine to 10 subjects received the FLULAVAL vaccine and are still experiencing arm pain and arm soreness. Some of the subjects stated that they experienced stinging at the time of the injection, but that could have been from the alcohol swab, All of the subjects received the FLULAVAL vaccine last year and did not experience any adverse events. The pharmacist reported another case, please see A1050673A.