chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received Moderna Covid-19 vaccine that underwent a temperature excursion; Patients received Moderna Covid-19 vaccine that underwent a temperature excursion; patients received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 027H21B, 030L20A and 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The temperature in the refrigerator that the Moderna Covid-19 vaccine reached  to 13.1 degrees Celsius on 28-JUN-2022 and on 19-JUL-2022 the vaccine reached a temperature of 9 degrees Celsius. None of the vaccine in the refrigerator underwent two different temperature excursions. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. No treatment details were reported.
right side face burning/ her cheeks were swollen and itched and burned; right side face swollen/ right side eyelid and the bottom of her jaw were swollen and itched/ her cheeks were swollen and itched and burned; right side eyelid and the bottom of her jaw were swollen and itched; right side face itching/ right side eyelid and the bottom of her jaw were swollen and itched/ her cheeks were swollen and itched and burned; right side eyelid and the bottom of her jaw were swollen and itched/ her cheeks were swollen and itched and burned; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in the left arm on 29Mar2021, at around 14:29 to 14:30 (at the age of 53 years old) as dose 1, single for COVID-19 immunisation. Medical history included asthma from 2006. The patient has no concomitant medications. On 30Mar2021, the patient experienced arm soreness. On 31Mar2021, she experienced right side face burning, right side face swollen, and right side face itching. The clinical course was as follows: The patient said her side effects were that she was just sore on the second day (on 30Mar2021), clarified that her arm was sore. She said that on 31Mar2021 (Wednesday), the right side of her face was burning and swollen. Her right side eyelid and the bottom of her jaw were swollen and itched, which continued until about 8 hours into her work shift of a 10 hours shift. She said she didn't have these side effects on the night prior, and it didn't come back, and she was at work at the vet office. The patient clarified that her cheeks were swollen and itched and burned. The patient put the anti itch cream on there and took an antihistamine, which helped a lot, and she didn't have these symptoms anymore (recovered on an unspecified date in 2021).   No follow-up attempts are needed. No further information is expected.
Received Pfizer COVID19 vaccine on 01/25/21 and 02/15/21. COVID positive 12/30/21.  Presented to ER on 1/1/22  for evaluation of SOB for the past few days. She tested positive for COVID on 12/30. She has also been having some diarrhea. In ER she was found to be hypoxic, placed on 3 liters O2 with good improvement in her saturation. Patient was admitted. Patient started on dexamethasone and remdesivir. Completed three days of remdesivir and 4 of steroids. Patient discharged with the remaining steroid course given nicotine use and possible underlying COPD. Dischaged without oxygen on 1/4/22
Had complications not related to the vaccine; First COVID vaccine in March, wasn't able to get the second dose until now; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now) in a male 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 ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now). The patient was treated with Surgery for Adverse event. At the time of the report, ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ADVERSE EVENT (Had complications not related to the vaccine) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now).    No concomitant medications were provided.  Treatment for the events were not provided.  Patient got first COVID vaccine in March and had surgery later and had complications not related to the vaccine and wasn't able to get the second dose until now.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.
Left arm swollen from shoulder to 2-3 inches from elbow, red down arm and extremely painful.
pt recv vax & fussed & stated did not want any more shots;pt cried during vax;pt became quiet & knees buckled under;reporter felt pt had fainted;pt was pale, felt cool & clammy;muscles were somewhat flaccid;became drowsy;throat hurst;
Sent from urgent care to ER on 9/19/21 after being found to have confusion. Patient presented to the urgent care for 4 days of fever, diarrhea and malaise. During evaluation in the ED she was found to be positive for covid test done in the urgent care, found to be hypoxic 85% on room air, was put on 5L oxygen. XR suggestive of covid pneumonia. COVID tested positive 09/19/2021. Vaccinated for COVID-19 February 2021, Pfizer. Started on antibiotic, dexamethasone, remdesivir.  Patient had Elevated D-dimer, CT angio negative for PE, ultrasound leg negative for DVT. Cr worsened to 1.5 but later on improved with IV hydration to normal.  Given 5 dose of remdesivir.  Started on dexamethasone 6 mg daily to be completed 10 days of for course.  And required oxygen will ranging between 4 L minimum of later with gradual decrease in the need.  Through the end of the course patient was on room air saturating at 93, required minimal oxygenation on nasal cannula with exertion and and patient will be requiring home oxygen accordingly.  Home oxygen is arranged to be followed up with her primary physician regarding further assessment of home oxygenation as outpatient.   Patient developed better bradycardia with heart rate ranging in the 40s that that required adjustment of her medications and to be followed up with Cardiology as outpatient to further adjust her medications.   Had altered mental status improved which is most likely due to respiratory failure from COVID pneumonia versus medication induced.   Her diabetes was managed with sliding scale and resume the home medications upon discharge   Restless leg syndrome was stable. Discharged on 9/24/21
soreness in arm wasn't as bad; Hair loss; terrible migraine; had a small lump after second dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (soreness in arm wasn't as bad), SWELLING (had a small lump after second dose), MIGRAINE (terrible migraine) and ALOPECIA (Hair loss) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Has only left kidney, as right was removed d/t possible cancer.). Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included TURMERIC [CURCUMA LONGA RHIZOME] for Arthritis, ATORVASTATIN for Hypercholesterolaemia, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZID) for Hypertension, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for Vitamin supplementation, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS ACIDOPHILUS, LACTOBACILLUS RHAMNOSUS (PROBIOTICS [BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS]), CALCIUM and NICOTINAMIDE (VIT B3).    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SWELLING (had a small lump after second dose). On 04-Mar-2021, the patient experienced MIGRAINE (terrible migraine). On an unknown date, the patient experienced PAIN (soreness in arm wasn't as bad) and ALOPECIA (Hair loss). On 05-Feb-2021, PAIN (soreness in arm wasn't as bad) outcome was unknown. On 11-Feb-2021, SWELLING (had a small lump after second dose) outcome was unknown. On 05-Mar-2021, MIGRAINE (terrible migraine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication includes Nutrasol supplement.  Patient had a "terrible migraine" for 24 hours, but her only history of previous migraines was during menopause 15-18 yrs ago.
PATIENT HAD A VASOVAGAL REACTION, WHERE HE FELT LIGHTHEADED AND DIZZY, AND UNABLE TO STAND FOR A LONG PERIOD OF TIME. RN HAD PATIENT WHEELED TO FIRST AID BAY TO LAY DOWN. PATIENT VITAL SIGNS WERE TAKEN AS MEDICAL STAT CALL WAS BEING MADE. MD EDUCATED PATIENT OF ADVERSE REACTION WITH VITAL SIGNS NORMALIZING AND PATIENT STATED HE WAS FEELING BETTER. PATIENT IS ALERT AND ORIENTED, ABLE TO STAND AND WALK AROUND. PATIENT VITAL SIGNS NOW 100% O2 SAT, 94 HR, RR 22, AND BP 104/71.
Starting late 4/16, arm sore and fatigue and dizziness.; Starting late 4/16, arm sore and fatigue and dizziness. Extreme Dizziness / vertigo continued With neck tightness, mild nausea, back ache on and off for 3 days before starting to reduce.; Extreme Dizziness / vertigo continued With neck tightness, mild nausea, back ache on and off for 3 days before starting to reduce.; Extreme Dizziness / vertigo continued With neck tightness, mild nausea, back ache on and off for 3 days before starting to reduce; Extreme Dizziness / vertigo continued With neck tightness, mild nausea, back ache on and off for 3 days before starting to reduce; Extreme Dizziness / vertigo continued With neck tightness, mild nausea, back ache on and off for 3 days before starting to reduce.; Starting late 4/16, arm sore and fatigue and dizziness.; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 16Apr2021 at 13:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The medical history included removal of one ovary / fallopian tube due to benign ovarian cyst removal in 2017 and shingles which was activated in 2019. The patient had no illness or chronic health condition. The patient's known allergies were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included acetylsalicylic acid (BAYER ASPIRIN) from an unknown date to 14Apr2021 for an unknown indication. The patient previously took varicella zoster vaccine rge (cho)(SHINGRIX) for immunisation since an unknown date. On 16Apr2021 at 21:30, the patient experienced arm sore, fatigue, dizziness. Extreme dizziness/vertigo which was continued with neck tightness, mild nausea and back ache on and off for 3 days before started to reduce. The patient reported that on day 4 (the day of this report) since vaccination, she had occasional dizziness, fatigue, mild nausea and no fever. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm sore, vertigo, neck tightness and back ache on and off were recovering, while the clinical outcome of the events dizziness/extreme dizziness, fatigue and mild nausea were not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Stuffiness might be due to getting moderna booster; Headache almost daily might be due to getting moderna booster; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffiness might be due to getting moderna booster), HEADACHE (Headache almost daily might be due to getting moderna booster) and INJECTION SITE ERYTHEMA (Redness at injection site) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASAL CONGESTION (Stuffiness might be due to getting moderna booster), HEADACHE (Headache almost daily might be due to getting moderna booster) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, NASAL CONGESTION (Stuffiness might be due to getting moderna booster) and HEADACHE (Headache almost daily might be due to getting moderna booster) had not resolved and INJECTION SITE ERYTHEMA (Redness at injection site) was resolving.            The concomitant medication was not reported by reporter. On unknown dates, the patient experienced stuffiness and headache almost daily might be due to patient received moderna booster and redness at injection site. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I was diagnosed with "Palandromic Rheumatism" in the fall of 2019 and started on Hydroxycloroquine in November 2019.   I had little join pain in the 15 months following the start of that medication.     I had dose one of the Pfizer vaccine on February 16, 2021 and did not have any immediate reaction.  However, my joint inflammation (related to "Palandromic Rheumatism") flared up within a week or so of the first dose.  I called my rheumatiologist and asked whether it could be related to the vaccine and received a "possibly".   I proceeded to get the second dose.     The joint pain has been significant and has persisted.  On March 31, I was prescribed prednisone.   Although there was some immediate relief, the pain has continued to come and go in my wrists.     My prescription will end in a few days and we shall see what happens.    My situation is tolerable and I am glad to be vaccinated.  However, my concern is that autoimmune disorders are agragavated by the vaccine.  I have a friend who has a similar situation tho much more seriously.   He had not considered that it might be related to the vaccine.   I just want to make sure the CDC is aware of these kinds of possible impacts, has the available data from those who have received the vaccine,  and can inform the public and the professional community and hopefully have some suggestions on preventive measures to avoid these kinds of reactions.
the rash was getting worse and she had "little bumps"; itching on her back; This is a spontaneous report from a contactable nurse. This nurse reported for self that the female patient of unknown age who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2021 at single dose for covid-19 immunisation. Medical history included allergies: persimmon. Concomitant medications were unknown. Prior to receiving the vaccine she had rashes on her arms which she thinks was a reaction from eating persimmons. She thinks the rash was from organic persimmon fruit since she was eating one a day. She stayed at the facility for an hour after receiving the vaccine and then went home. She states that after receiving the first dose of the vaccine she went home and took a shower and noticed that the rash was getting worse and she had 'little bumps'. On the third day the rash started getting better and now it is completely gone. She realizes that it is hard to tell if the COVID-19 vaccine caused any adverse effects because she already had the skin rash prior to receiving the first dose, however. she is due for the second dose of the vaccine and wants to know if she could safely proceed with getting the second dose. She was taking a shower and she noticed itching on her back and she was scratching and saw bumps. Reports the rashes were a little bit more, and it was not too much itching, and on the third day she took Benadryl. Reports it is all gone now. She was thinking to talk to her doctor and thought it must be from the persimmon fruit since she had the rashes prior to the vaccine. She is asking if she should get the second dose. The outcome of the events was recovered.   Information about Lot/Batch has been requested.
I developed atrial fibrillation with five days of the injection. I have never had atrial fibrillation before in my life. It persisted for three weeks and I then self-converted.
A numb/tingling feeling on the left side of my face; A numb/tingling feeling on the left side of my face; Tingling sensation in both cheeks; My face feeling/looking flush that night; This is a spontaneous report from a contactable other hcp (Patient).  A 41-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in Arm Left on 01Feb2021 15:45 (age at vaccination: 41-year-old) as single dose for an covid-19 immunization. Medical history included graves disease in remission. There were no concomitant medications. The patient previously took amoxicillin and experienced drug allergies. Patient not tested covid prior and post of vaccination. It was reported that patient experienced Tingling sensation in both cheeks while drive home (approximately 30 minutes after shot). Went away after a few minutes but left her face was feeling/looking flush that night. About 24 hours on 02Feb2021 later she was developed a numb/tingling feeling on the left side of her face. This feeling continued so called her Drs office on 03Feb2021 to let them know. They told if symptoms worsened she should go to the ER. She woke up on 04Feb2021 and the feeling had gone away, but returned in the afternoon and persisted. Woke up this morning 05Feb2021 and the feeling was gone but returned by 10 am and is still persisting. The outcome for the events was not resolved.   Follow-up attempts are completed. No further information is expected.
pt states that site of inj turned red & spread over most of the upper lt arm & the pt also stated the inj site felt hot w/swelling, pt also stated the lt felt tingly;
The patient developed painful red swollen right third, fourth, and fifth toes without fever 3 days after her second Pfizer COVID-19 vaccine had been given at a pharmacy on 12/11/2021.  There was no history of trauma, bee sting or walking around in wet shoes in the rain.  She was seen in our pediatric office on 12/16/2021.  An X-ray of her foot was showed no bony changes and she was treated with Aleve as needed for pain and a 10-day course of cephalexin for a possible cellulitis.  On 12/17/2021 a phone consultation was done with Hospital Pediatric Infectious Disease specialist Dr., who stated that chilblains have been described following COVID-19 vaccination.  At her office recheck on 12/18/2021 the swelling and redness were improving.  Although CBC, differential, CRP and ESR had been recommended, no lab work was obtained.  The patient was again seen in our office on 01/06/2022 because the patient developed superficial peeling of the same 3 toes.  The redness and swelling had resolved, but the toes were still slightly tender.
Pain at injection side for a week. Fevers for 2 days up to 103.9. Fever stayed around 102.5 despite taking IBU every 5 hours. Severe fatigue. Then on day 3 had severe nausea.
Red, "bubbly" rash on same hand as PNEUMOVAX vaccine occurring about an hour after administration.