chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 Vaccine EUA I received the vaccine on 3/13 at 3:45pm and began experiencing symptoms on the day at 5:30pm including dizziness, nausea, fatigue and wiped-out exhaustion, drunk-like dazed and confused, body heaviness, and developed soreness in the muscle of the right arm where the injection had been administered. The symptoms progressed at 6:30pm to include general muscle soreness, muscle twitching on the right side of the body especially on the right upper thigh, increased appetite, malaise, headache, and chills in addition to the aforementioned symptoms. At 7:30pm the nausea and increased appetite improved with food and fluid intake but sleepiness, yawning, confusion, chills, and fatigue worsened at 8:30pm. Temperature at 9:30pm was 95.7 degrees Fahrenheit and a pale, green-like, clammy appearance was visible on the general skin. At 10:30pm the sleepiness reversed to restlessness and insomnia to the point of hyperactivity, and the appetite increased four-fold along with rash up and down the injected arm, numbness and tingling in the injected arm, chest discomfort with palpitations, anxiety, headache, stomach pain, malaise, and general limb edema which all persisted until I was able to fall asleep at 6:30am on 3/14. Many of the aforementioned symptoms improved upon wakeup time at 4pm on 3/14, but extreme sleepiness with nausea, dizziness, fatigue, head pain and right eye pain, and palpitations with chest discomfort persisted until 10am on 3/15, during which time only the nausea, dizziness, and fatigue persisted.
PROQUAD, a MMR and Varicella combo vaccine was administered to the patient. He is 16 years old and vaccine is indicated for children 12 months to 12 years of age only. No adverse reaction has been noted, but the patient is outside recommended age range.
Diarrhea  Pain at injection site, the 4th day chills, the 5th Day diarrhea  Narrative:
Information has been received from a physician concerning a 14 years old female student with no drug allergies, recurrent cold sores and Attention deficit/hyperactivity disorder who, on 19-MAR-2007 at 10:00   was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Gardasil (Lot# 656741/12084). Concomitant vaccination included meninigococcal vaccine (unspecified) and concomitant therapy included ADDERALL. Subsequently, at approximately 10:05 the patient felt "funny" and briefly passed out (previosulsy reported as felt dizzy) and fainted. The patient fell to the floor. After falling the patient woke and was able to walk to the exam table and laid down for a while where she felt better. The physician reported that fainting was due to a vasovagal reaction. The patient then seemed ok and walked out of the office. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on 19-MAR-2007 recovered on the same day as when the injection was given. No product quality complaint was involved.   This is one of several reports from the same source.   Additional information has been requested.
Information has been received from a nurse concerning an "around 80-year-old female" who on approximately 11-JUN-2007 was vaccinated with an injection of Zostavax (Oka/Merck).  "Immediately after getting the vaccination, the patient presented with a little shingles case around the injection area (pustules)".  Also the patients "FED blood rate was elevated".  It is unspecified if medical attention was sought.  It is reported that the patients condition is improving.  No product quality complaint was involved.  Additional information has been requested.
pt w/heme + stools 8 days p/vax;resolved 3 days later;gross blood was noted in stools;
Excruciating headache, vomiting, lethargic, shivers, shakes, fever
Information has been received from a registered nurse concerning two pts who were vaccinated with the 1st dose of varicella virus vaccine live (site unknown) Subsequently, the pts developed swelling in the injection area. There was no further information available.
On ThursMar 25th about 2000hrs I began feeling warm, temp 99, by 0200 Fri Mar 26th temp was 101.8 and stayed >101 until I got up on Sat Mar 26 about 0900. I also had a low grade headache 3/10, sore muscles, and impaired balance and fatigued on Fri Mar 25th.  I did not feel dizzy.  On Sat Mar 26 I still felt weak/fatigued.  I did my gym work out today Mar 29th and it was a little harder than last week. I have been working out 5 days per week for the last 3 months.
No Adverse Event; Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart) and NO ADVERSE EVENT (No Adverse Event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd primary Monovalent  dose 9 months after The  first dose/Received the 2 primary doses too far apart).    No concomitant medications were reported.  No treatment information was provided.
Two days of worsening nausea, vomiting, flushing, injection-site pain, and local erythema at injection site that increased in size.  No fevers or other symptoms.
Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023; No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023).    No concomitant medication was reported.  Dose was placed into the refrigerator initially on 04-MAY-2023. No treatment information was reported.   This case contains information for patient 6 out of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
I noticed on the 14th that I had a large bump or growth on my left calf. It just suddenly appreared that day.
Booster dose; Booster dose; Decreased thyroid function; Decreased thyroid function; This is a spontaneous report from contactable consumer (patient). A 74-year-old female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: FF2588) on 30Aug2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included celiac from 05Feb2017 and ongoing (also reported as diagnosed 2014), hypothyroidism from 1985 and ongoing, mild depression from 1972 and ongoing, high blood pressure from 1992 and ongoing and old age from an unspecified date and ongoing. Concomitant medications included levothyroxine orally taken for hypothyroid from an unspecified date and ongoing at 0.075mg, citalopram orally taken for depression from an unspecified date and ongoing at 10mg and estradiol orally taken for old age from an unspecified date and ongoing at 0.5mg. Prior vaccinations were reported as none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6202) on 24Feb2021 (at the age of 74-years-old) as a single dose in the left upper arm for COVID-19 immunization and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EP6955) on 24Mar2021 (at the age of 74-years-old) as a single dose in the right upper arm for COVID-19 immunization and experienced decreased thyroid function, increased atrial fibrillation, hair loss, bruising, slight confusion, memory loss, exhaustion, significantly increased depression and sensitivity to cold. On an unspecified date in 2021 (summer 2021), the patient experienced decreased thyroid function. The event was reported as serious for medically significant and required a physician office visit. It was reported that the patient's thyroid supplement stopped working. The first step was to switch from generic levothyroxine to name brand Synthroid. New bloodwork was scheduled for 03Nov2021. The next stop would be to increase dosage of Synthroid if the 03Nov2021 bloodwork, showed no improvement for return of hypothyroidism. Symptoms were reported as "many". The patient underwent lab tests that included: TSH (0.300 to 4.500) on 31Dec2019 which was 5.340 uiU/mL; on 17Aug2020 which was 4.933 uiU/mL; on 08Mar2021 which was 4.838 uiU/mL and on 14Sep2021 which was 8.141 uiU/mL. Treatment was received for the event decreased thyroid function. The clinical outcome of the event decreased thyroid function was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Died after developing Hib meningitis. MD sending samples to CDC for analysis. Reported that the child had some form of immune deficiency. Father told MD he also had a form of immune deficiency.
She started to become floppy with 24 hours.  We took her to the doctor and she went completely limp 24 hours after that.
Drug ineffective; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 14Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 06Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ana postive speckled" (unspecified if ongoing), notes: Other medical history: Ana positive speckled. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication within 2 weeks of vaccination and also received Paxlovid as a treatment of COVID-19 from 26May2022 to 30May2022. Other medication included Sulfate, Pernsdione. No known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported LOE events and the suspect drug cannot be excluded.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. The treatment information was not provided.
No adverse event. Patient was supposed to get a second dose of 0.5ml, but received only 0.25ml. Offered patient a second 0.25ml dose, but patient refused. She did not want the full dose after receiving just the half dose.
swelling under her cheekbones on her face; she received the booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 18Aug2021 (Lot number: FC3182) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, Covid-19 First dose: , Lot: EL9265, Expiry date: 31May2021, Dose Unknown, injection in the left arm for all 3 doses.), administration date: 05Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Caller said that with the first dose she had nothing"; Bnt162b2 (Covid-19 Second dose :, Lot: EN6203, Expiry: 30Jun2021, Dose Unknown, injection in the left arm for all 3 doses. , Caller said that with the first dose she had nothing. With the second dose, after about 12 hours she got sick for 12 hours. It was very odd. Part of her body was hot and part was cold. She had ice packs on part of her body and heating pads on the other parts. After 12 hours it was gone. It was nuts.), administration date: 26Feb2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "she got sick for 12 hours", "Part of her body was hot and part was cold", "Part of her body was hot and part was cold", "It was very odd/It was nuts.". The following information was reported: IMMUNISATION (non-serious) with onset 18Aug2021, outcome "unknown", described as "she received the booster dose"; SWELLING FACE (non-serious) with onset Oct2021, outcome "not recovered", described as "swelling under her cheekbones on her face".  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in emergency room or physician office visit. The reporter assessed the events as non serious. Relevant tests was reported as none. No additional vaccine was administered on same day as suspect. Patient experienced facial swelling under her check bone after the booster dose. it did not started right away and " it was not horrible" but now she has it under both check bone. it was under one check bone before. The patient said that she had her Botox, but she had the swelling prior to going. She said that after the 3rd Covid-19 shot it got worse.   Follow-up attempts are completed. No further information is expected.
Headache, chills, low grade fever developed 24 hours after receiving vaccine - resolved in 2 days.
Rt thigh immediate skin redness, swelling and pain - ice pack applied. Local reaction.
Tired, sore arm- started about 10:00am  Not OTC or medication treatment needed, took nap and rested
Patient reports that after vaccine administration she presented redness in the injection site, arm pain, and induration. Patient refers that she applied ice on the area and took Panadol.
Had the shot on June 16th. On June 20th when I went to get out of bed my back was hurting and continued to get worse as the day progressed. By Wednesday I was in such severe pain that I went to Urgent care and they said I had severe inflammation in the middle of my back. I was sent to a chiropractor, and a massage therapist before finally having an MRI done on my back which showed I had a fracture in the center of my back. I believe that this came about after being sent to the chiropractor and one of the instruments that was used on my back caused that. I have been put on steroids and pain meds for the inflammation and still have pain in my back. I have gotten my booster shot and had mild flu symptoms and the pain got severe again. Some days it is extremely bad and some it just hurts. I believe that this has been brought about from the shot.
Patient feels a bubbly effervescence feeling at shoulder and up to side of neck periodically.
Information has been received from a consumer concerning a 14 year old daughter with no pertinent medical history reported and no known drug allergies, who on 23-AUG-2007, 09-DEC-2008 and 06-FEB-2009 was vaccinated with first, second and third doses of GARDASIL (route and lot numbers not reported). There was no concomitant medication. The consumer stated that her daughter had injection site pain after each injection, lasting for a day. No lab studies were performed. The patient sought unspecified medical attention. Follow up information was received from a Licensed Practical Nurse (L.P.N) concerning a 16 year old (also reported as 14 year old) student patient who on 23-AUG-2007, 09-DEC-2008 and 06-FEB-2009 was vaccinated with the first, second and third doses of GARDASIL (respectively). It was reported that the patient never reported to the office any ill or complaint in regards to this vaccine. It was reported that the patient received two doses through her office and never reported anything. No further information is available.
Mother called to state her son had Td booster given and last night complained of increased swelling at injection site left deltoid and low grade temperature about 99.6.  Mother is calling and wondering if there is anything to give him.  Told her Tylenol or Motrin would be fine.  To seek pediatrician assessment if temperature increased to about 100.5.
Received vaccine 04/09/2021 at 9:13 AM. Experienced light concentrated headaches around 11pm on the same day. Around 12:30AM 04/10/2021 when trying to sleep experienced cold and hot flashes. On 04/10/2021 4:00AM experienced more hot flashes. From 7:00AM till the time of filling this form (9:00AM) experiencing noticeable back pain (uncomfortable) - muscle pain concentrated on the back.  As of 9:00AM 04/10/2021 no other side effects.
This spontaneous report has been received from a consumer, who was referring to her husband, currently 74 year old male patient with no drug reactions or allergies. The patient's medical history included heart surgery (date unspecified) and one bout of shingles before getting the shot of ZOSTAVAX (date unspecified). In 2012, reported as sometime in early fall 2012, the patient was vaccinated with ZOSTAVAX vial, (lot #, dose, strength, route, frequency not reported) to prevent shingles. Concomitant therapies included metformin, metoprolol, CRESTOR, ALLOPURINOL, lisinopril (manufacturer unknown) and tamsulosin hydrochloride. It was reported that since getting the vaccine the patient experienced two bouts of Shingles. On an unknown date, soon after getting the vaccine, the patient experienced a bout of shingles. At the to date of the report, reported as right now the patient had a second bout of shingles (adverse events onset date in approximately 2013). It was reported that he had a rash on his stomach and his back. The patient was treated with unspecified medication. The patient was seeking medical attention by visiting physician. No diagnostic laboratory tests were performed. The outcome of first bout of shingles was unknown. The outcome of a second bout was reported as not recovered. Relatedness between the events and ZOSTAVAX was not assessed by the reporter. Additional information has been requested.
Individuals with severe muscle pain; Individuals with sever side effects that was not considered allergic response; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ADVERSE EVENT (Individuals with sever side effects that was not considered allergic response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL), NEFOPAM HYDROCHLORIDE (ACUPAN) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Individuals with sever side effects that was not considered allergic response). At the time of the report, ADVERSE EVENT (Individuals with sever side effects that was not considered allergic response) 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 did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
ARM SWOLLEN NEARLY TWICE NORMAL SIZE. EXTREME REDNESS, WARM TO TOUCH, PAINFUL. PATIENT REPORTS NO FEVER/CHILLS/OTHER SYMPTOMS.
I had a blood clot that blocked my right anterior descending artery causing me to have a heart attack.  I was air lifted to the hospital where the clot was removed.  The surgeon had no explanation for the clotting and I had no other heart issues aside from high blood pressure.  No symptoms except I was very tired after second shot.  Plaque was not the cause.
Small raised papule on upper (R) forearm with mild erythema on 10/6/11. Mom repots on PM of 10/4 child developed blister at site of injection that was painful, itchy. Blister burst exuding watery material, no pus, no fever, no other complaints.
Administered bivalent Pfizer instead of monovalent Pfizer as first dose in series
Venous Sinus Thrombosis, Intracranial Hemorrhage, Seizure
PATIENT WAS ONLY 17 WHEN COVID 19 MODERNA VACCINE WAS ADMINISTERED.