chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; 1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (First dose of Pfizer) on 26-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (1st Dose was taken as Pfizer and 2nd Dose was taken as Moderna) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine).    No concomitant medications were reported.   Caller reports one of their nurses gave incorrect second dose of Moderna covid vaccine to a patient which should have been Pfizer covid vaccine. Patient was accidentally said yes to getting Moderna vaccine but marked Pfizer vaccine on questionnaire.  No treatment medication was provided.  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.
On Saturday, April 3rd,  patient told her son she was tired and was going to take a nap.  Her son tried to wake her the next morning since she had not come out of her room from the day before.  He was unable to wake her.
chills for about 10 hours fever for about 20 hours migraine for 24 hours Tylenol taken every 6 hours
anaphylactic reactions; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (anaphylactic reactions) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Asthma, Allergic rhinitis, Chronic urticaria and Food allergy.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reactions) (seriousness criterion medically significant). The patient was treated with SALBUTAMOL (ALBUTEROL HFA) ongoing since an unknown date for Asthma, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (anaphylactic reactions) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (anaphylactic reactions) to be possibly related.    Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient had symptoms of Generalized itching, hives, Shortness of breath (SOB). Patient declined skin test and received and tolerated 2nd dose in high-risk clinic  Company Comment: This case concerns a 32-year-old female patient, with history of asthma, food allergy, chronic rhinitis and chronic urticaria, who experienced the serious expected event of ANAPHYLACTIC REACTION. The event occurred on an unknown date after receiving the first dose of Moderna COVID 19 vaccine. The rechallenge is not applicable, since it is stated that patient tolerated the second dose with prior administration of albuterol. Patient's history of asthma, food allergy, chronic rhinitis and chronic urticaria remains as a confounder. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-372371, MOD-2021-372465, MOD-2021-372466 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety on 04-Nov-2021 included an Email with FTA received from team. Reporter information, Treatment drug are added.; Sender's Comments: This case concerns a 32-year-old female patient, with history of asthma, food allergy, chronic rhinitis and chronic urticaria, who experienced the serious expected event of ANAPHYLACTIC REACTION. The event occurred on an unknown date after receiving the first dose of Moderna COVID 19 vaccine. The rechallenge is not applicable, since it is stated that patient tolerated the second dose with prior administration of albuterol. Patient's history of asthma, food allergy, chronic rhinitis and chronic urticaria remains as a confounder. The benefit-risk relation of Moderna COVID 19 vaccine is not affected by this report.
Patient received vaccine and was fine until after a few minutes.  He started to say he felt lightheaded.  He placed is head between his knees, he started to sweat and I gave him some water at his request.  He sat back and started to get pale and more sweaty, he complained about pain in his arm and neck.  He then began to slightly shake and passed out.  He was awoken very quickly by his wife who was standing in front of him.  We kept talking to him and I checked his pulse and called 911.  After about 30 minutes he was feeling much better and did not need to go to the hospital.  His vitals were strong and he walked out on his own.  I contacted him 3 hours later and he was resting but feeling fine.
Pt states he had a rash that started about 2 hrs after receiving his 2nd Modena Covid vaccine. Pt states rash covered his entire body. Pt was prescribed Levocetirizine, Famotidine and Prednisone.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 18-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011606: US-009507513-1807USA012253: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254: US-009507513-1807USA012257:
No side effects until 8 hours later. Started feeling dizzy occasionally, especially when I turned my head. Dizziness worsened over the evening to the point where almost any movement made me dizzy. Extreme muscle and body aches around 8pm continuing now. Feeling very weak and had chills throughout the night. These symptoms feel exactly how I felt when I had covid on 12/28/20.
I was released from quarantine from my Covid-19 infection 5 days prior to getting the first Moderna vaccine in the morning. By the evening, I felt sicker than I ever have in my entire life. I was shaking uncontrollably, had a fever, extreme chills, and a pounding headache and muscle aches. I didn't sleep that night and couldn't get out of bed until noon the next day. I am still lethargic today and seemed to have lost my sense of smell.   My Covid-19 symptoms from the 2 weeks prior were extremely mild and the vaccine experience was 1,000x worse. Something isn't right and I am questioning whether I should get the second shot.
pt recv vax 23MAR98 & mom presented pt w/low grade fever, small petechia rash on upper chest;tongue had white coating on it & rash;30MAR98 pt had appt @ dentist for molar extraction;was on ATB prev to extraction for 7 days;
p/vax pt exp acutely swollen lt knee w/acute lt knee effusion; MD stated most likely gout;
Red spot at the injection site that will not go away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot at the injection site that will not go away) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at the injection site that will not go away). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot at the injection site that will not go away) 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.
First dose on 07/25/2016, the patient will receive the second dose on 4/30/2019; No adverse effect; This spontaneous report was received from a medical assistant concerning a female patient of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medications.  On 28-JUL-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M005714 with expiration date of 03-OCT-2017, for prophylaxis (dose, route of administration and anatomical location were not reported). It was reported that the patient would receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on 30-APR-2019. No adverse effect was reported.    Lot No. M005714 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported as 03-OCT-201, but upon internal validation established as 03-OCT-2017.
Client verbalized redness and tingling at the vaccination site.  Client was evaluated by onsite.  Client was released to go home at 10:34 am once symptoms resolved.
On 8/22 I called my doctor with intense hip and leg pain the night before and was concerned about a possible DVT because of a previous history.  I went to Hospital Emergency Dept and had ultrasound of left leg which was negative for clots and was sent home.   I spoke to doctor's office on 8/23 and was put on 50 mg prednisone decreasing dose by 5mg each day for sciatica.  On 8/27 I saw Dr. and was diagnosed with shingles rash on my lower left leg. I understand that this vaccine is not a live virus and therefore I  cannot contract shingles from the vaccine but I find it hard to understand the onset being so close to receiving the vaccine.  As a note, I did receive the Zoster vaccine for shingles on 9/30/2013. If this is all a coincidence, I guess I will have to accept that, but I think you should be notified.  Getting the second part of this vaccine is a very scary thought right now.
postherpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around February 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered shingles and postherpetic neuralgia. As a direct and proximate result of the vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the product, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the events to be disability.
I woke up Tuesday morning with a slight sore throat. As the day went on, I felt feverish, but I did not have a fever, I did take it. I went to bed and slept eleven hours. When I woke up, I had a runny nose, felt feverish, chills, body aches, slight headache. We were driving back from a camping trip and even with all that rest I did not feel like I could drive. I had my wife drive the other half of the trip. Once we got home, once home I took a home COVID-19 test that came back positive, I took my temperature and had a low-grade fever. I called my primary care physician who prescribed Paxlovid that I started taking immediately. I am on day two and I only have a runny nose and have a bit more energy.
11-17-13: Seizure like activity. Jerky side to side eye movements, followed by eyes rolling to the back of her head. Increased muscle tone throughout her body; then generalized weakness. Lasted 30 min's. Pt was aware of what was going on/followed direction but was unable to see during these events.
I got a kidney stone on 1/9/2021. Another lady in my office building also got one.
On 1/27/2021 around 4 in the morning I woke up with headache, nausea, high fever (102.6), chills, body aches, shaking. Took Tylenol to reduce fever, fever kept increasing took ibuprofen around 7 pm and fever began to go down after about an hour. Temp not as high as previous day and nausea on 1/28/2021. 1/29/2021 very low grade temp and tired, mostly back to normal.
SWOLLEN RIGHT ARM, NO TREATMENT HAS BEEN ADMINISTER.  NO OTHER SYMPTOMS.
Two silver dollar size red, perfectly round rash, feverish to touch and hard, slight itch and heavy arm feeling, about 2-3 inches below injection site. Appeared on day after initial injection, then disappeared within 48 hours. The patches reappeared on day 8 after injection and were in exactly the same places on the arm, same appearance and characteristics. Again disappeared within 48 hours. Has not seen anything since.
A serious clinical trial report of a Grade 3 miscarriage was received from an investigator concerning a 26 year-old female, who is enrolled in a study. The subject's medical history included: dysmenorrhea (1994), tension headaches (2000), anemia (11/2008), and menorrhagia (10/2008 to 12/2008). Concomitant medications included acetaminophen: Rho (d) Immune Globulin (Human) Injection, naproxen sodium, and extra strength acetaminophen. Method of contraception used during the study by the subject was condoms and spermacide. The subject's last menstrual period was 11-July-2009. On 21-August-2009, the subject received on 0.2ml dose of MEDI8662-BFS. This was the subject's first and only dose as per the study protocol. On 18-Sep-2009, the subject went to the emergency room for abnormal vaginal bleeding. A serum pregnancy test was done and had a positive result. A sonogram of the uterus showed: size 10.8 X 6.6 X 5.9 cm. The uterus not be confirmed, probably due to technical reasons rather than physiologic reasons. The left ovary could not be seen either transabdominally or tranvaginally; and the adnexel regions were within limits; there was no pelvic free fluid. The age determination showed a gestational sac of 1.85 cm or six weeks two days, a crown-rump length is 1.27 cm or seven weeks three days. Fetal heart rate was confirmed at 152 beats per minute with M-node scanning. Intravenous saline was administered for dehydration prophylaxis and acetaminophen 650 mg was given for low back pain secondary to abnormal vaginal bleeding. Rho (D) Immune Globulin (Human) injection 50 mcg was also administered prophylactically to prevent fetal death. The subject was released from the emergency room and reported on 22-Sep-2009 that everything was fine. On 23-Sep-2009, the subject was again seen in the emergency room and had miscarriage. She was instructed to follow up with her gynecologist. Treatment for the event of miscarriage was not reported. The event of Grade 3 miscarrage resolved on 23-Sep-2009. Rechallenge is not applicable as in this clinical trial only one dose of study drug is given. The investigator assessed the relationship of the event miscarriage as possible. Analysis of similar events: a search of the safety database for the preferred term of miscarriage was performed on 28-Sep-2009 and noted only this case of miscarriage after the administration. Clinical trial case - patient was found not to be on FLUMIST when unblinded. 19-Feb-2010.
shingles; Information has been received from a lawyer and a consumer (reported as spouse) referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 06-FEB-2011, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Began having Joint pain sides, and back in Hip area. Still has today, however Extra Strength Tylenol 2 is relieving today.
vaccine was given 6/13 and the BUD was 6/2. no symptoms occurred.
4cmx6cm area of red- swollen - tender. Resolved on its own in about 24 hours.
2/16/21 evening of second dose- had some shortness of breath during high intensity interval training but thought it would go away. 2/17/21 morning clarinet practice went poorly- trouble producing appropriate tone so I quit practice figuring it was just a bad day. 2/18/21 morning clarinet practice was a disaster- playing just three notes made me gasp for breath. I kept trying thinking it would settle down but SOB grew worse to the point of dizziness. I would have collapsed if I had not sat down immediately. I've been doing the exercise training for years and playing clarinet for 20 years so I know what breath support is like under intense situations. This was a big problem. The Clinic Nurse Line sent me to the Emergency Room immediately.
Rash that looked like scalded skin with blisters; Rash itched but, burnt intensely; Blinding headache; Body aches; Tickle in throat; Wheezing; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 16May2021 at 11:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation Medical history included Sjogren's and penicillin allergy. The patient previously took CIPRO and experienced allergy. The patient received other unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 02May2021 at 11:00 (at the age of 41-year-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 16May2021 at 15:00, the patient experienced rash that looked like scalded skin with blisters, rash itched but, burnt intensely, blinding headache, body aches, tickle in throat and wheezing. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with BENADRYL. The clinical outcome of the event rash that looked like scalded skin with blisters, rash itched but, burnt intensely, blinding headache, body aches, tickle in throat and wheezing were recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Urine had a odor its really strong .. right after vaccine , nausea and headaches  Urgent to urine after the 1st dose  No pain
Hours after the 2nd dose of the vaccine, I was severely fatigued, which passed with in a day. However, 3 weeks later, I was again extremely fatigued and had right sided abdominal pain. Initially, it was thought to be gallbladder related, but subsequent ultrasounds showed no issues with my gallbladder at the time.
chills in the morning after the injection. Then  body aches and  headache the whole day after the injection and into that night.  Took Tylenol and went to bed.  By the second day after the injection I was left with a shadow of a headache.  By the third day after, I was well.
Patient received vaccination at 0900 on 12/30/20 Patient began feeling throat tightness and chest heaviness approximately 15 minutes post injection.  Symptoms were not severe and did not require medical intervention. At/around 1200 on 12/30/20, patient reports chest heaviness resolved, by mild throat tightness was ongoing At/around 1700 on 12/30/20, patient's legs began feeling itchy but rash/hives did not develop All symptoms resolved by 1900 on 12/30/20 without medical intervention
Case number PHEH2015US026851, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 44-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 13 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degree). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event reported following this medication errors. Follow up information received via nurse on 26 Jan 2016: Reporter's comment updated.