chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091F21A, 013L20A and 02AL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 27-Oct-2021, HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Expiration dates for all 3 doses are unknown.   This case was linked to MOD-2021-367092, MOD-2021-367111, MOD-2021-367396 (Patient Link).
Body pains; Chills/ shivering; Feeling a little weak; Fever; Wasn't able to sleep; Severe headache; Even when you touch his body it hurts. Patient added especially his shoulder where he took the vaccine; This is a spontaneous report from a contactable consumer. This 38-year-old male consumer (patient) reported that: A 38-years-old male patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0179), via an unspecified route of administration, administered in right of his shoulder on 19May2021 at 06:00 as single dose (at the age of 38-years-old) for covid-19 immunisation. Medical history was none. Family history included Mom and Dad have blood pressure and diabetes. Patient mom has this eye issue, glaucoma. The patient's concomitant medications were not reported. Patient previously took first dose of bnt162b2 (Solution injection; Batch/Lot Number: FW0179), via an unspecified route of administration, administered in left of his shoulder on 27Apr2021 at 05 20 as single dose (at the age of 38-years-old) for covid-19 immunisation. Patient did not take any other vaccine prior to the first administration of the suspect vaccine. The patient experienced shivering and all that along with body pains. Even when you touch his body it hurts. Patient added especially his shoulder where he took the vaccine. Patient reported that he drove home after the shot. He was at home for about 45 minutes. After 4-5 hours he was feeling a little weak, thought it was normal. Within 3-4 hours of time, he was having a fever, he knew it was normal, and he went to bed around 9pm. He thought he was feeling cold. He got a blanket to cover his body. Was feeling a little warm, when he took the blanket off he was feeling cold. Since then, he couldn't even close his eyes to sleep, was having pain all over his body. When he shakes his head there was pain all over his head. He had a severe headache, so last night he took Tylenol to try to see if he can bring the pain down. It helped a little bit, but he woke up this morning still feeling the same. He couldn't sleep because of the pain. When he touched his shoulder where the vaccine was given, it was very painful. He could not sleep the whole last night. Later, he was a little bit ok. It was a little bit improved. He was not shivering anymore, but the AC was off and he put fan on low mode. He reported that even now he wants to go to sleep but when he laid down, he moves from the left to the right, and had pains all over his body. He wishes he could sleep, but he can't. He stated that he had not taken his temperature, but stated he still having a fever today. He took tylenol for headache which helped a little bit but still has it today. Patient stated that his wife took his temperature, and it was 177/108. Clarified with patient that his wife checked his blood pressure. It was a wrist cuff. Pulse was 78. Therapeutic measures were taken as a result of body pains and severe headache. The clinical outcome of the chills and insomnia was unknown while the outcome of all the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Child had approx 6 lesions yesterday that resembled mosquito bites according to her mother. Today her mother said she has approx 10 lesions that resemble a varicella like rash. Mother denies child having any malaise, pruritus or fever.
Patient had swelling in face right where she had cosmetic filler injected. She said it was hot to touch.
Patient received Moderna primary series, then received Pfizer booster. Three days after booster, patient reported severe back pain, weakness, trouble with balance and standing, and worsened tremor.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 16-JUL-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly(reported as vaccine temperature excursion) (Product storage error).
When I got the 1st dose I got a fever 102 and my body was aching, full body sore and barely walk. After that I started to feel pain,  sore and stiff wrists .
Patient had arm swelling, chills, shaking and vomiting approximately 7 hours after vaccine administration.
Patient began feeling nauseous at 11:15, mild emesis.  BP 124/75, p-73,  No complaint of chest pain or shortness of breath, no difficulty swallowing.  Patient transferred to observation hub and Epinephrine 0.3 mg given by paramedics.  Vital signs monitored by paramedics and after 30 minutes, patient released to home with caregiver
On April 1st we got our 2nd vaccine. On April 8th pt began coughing and feeling weak and dizzy.  Nothing loose every came out but the coughing has not stopped. The family doctor prescribed a nasal spray nonsteroidal along with a chest Xray which came back clean. With no relief and  and shortness of breath I took pt to emergency on May 31st. She had 2 breathing treatments, a CT scan and covid test. Nothing was found and a 3 day Steroid was prescribed. The coughing subsided for those 3 days and returned with tiredness and coughing. Another Doctor's visit with nothing found on June 8th and a multiple steroid prescription. Still no improvement. Pt is feeling weak and still coughing. Please help!!!
Patient suffered severe short term memory loss starting at 7am on 2/3 and continuing until approximately 7pm on 2/3. Patient was stuck in a 2 minute or less loop for the entirety of the day. Patient went to ER and was checked into hospital overnight for monitoring. While patient MAY have taken a fall and suffered a concussion, MRI and CT scans showed nothing confirming this or any other indications of what was causing the short term memory loss.
Appendicitis; Developed a pain in his stomach; Could not sleep as the pain persisted in his stomach; Waking up a few times due to stomach irritation; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No Adverse Event (No medical history reported.).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced EPIGASTRIC DISCOMFORT (Waking up a few times due to stomach irritation). On 28-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Developed a pain in his stomach) with INSOMNIA (Could not sleep as the pain persisted in his stomach). On 29-Mar-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to APPENDICITIS. On 21-Mar-2021, EPIGASTRIC DISCOMFORT (Waking up a few times due to stomach irritation) had resolved. At the time of the report, APPENDICITIS (Appendicitis) and ABDOMINAL PAIN UPPER (Developed a pain in his stomach) outcome was unknown. admitted for emergency appendectomy    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Computerised tomogram: diagnosed appendicitis (Inconclusive) diagnosed appendicitis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-062483 (Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-062483:wife case
mental fog, severe fatigue, chest pain, elevated d-dimer, neg chest CT fatigue gradually improving though not to baseline as of 4/28/2021
About an hour and a half after the injection, had  minor swelling and redness, with hives appearing on neck above injection site.  Swelling dissipated within several hours.  Hives remained for 28 hours after vaccination. Vaccinator indicated I had minor skin flushing, with no fever or  change in heart rate at the time of injection. Remained for observation for 30 minutes.
Information has been received from a 81 years old female consumer referring to herself. The patient had no pertinent medical history. In 2006 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date not reported). Concomitant therapy was not reported. On approximately 24-JUN-2016 (reported as "3 days ago") the patient developed shingles. The patient spoke to the physician. Unspecified medicine was given for the event. No laboratory test was performed. The outcome of the event was reported as recovering/resolving. Reporter's causality was not provided. Additional information is not expected as there is no contact information for the reporter.
This spontaneous report as received from a consumer via nurse practitioner (also reported as physician) via field employee refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. The consumer reported that there was information on the internet that stated that unspecified female patient received a three dose series of GARDASIL (dose, route of administration, lot number and expiration date not reported) or GARDASIL 9 (dose, route of administration, lot number and expiration date not reported) and that the patient experienced many unspecified  side effects (date unspecified). The outcome of the event was not reported. The relatedness between the event and the GARDASIL and GARDASIL 9 was not reported. Additional information has been requested.
Breakthrough case admission after two vaccines Moderna 4/8/21 Lot# 037A21B;  Moderna 5/5/21 Lot# 024C21A;
expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not given.   This case was linked to MOD-2021-350559 (Patient Link).
Mild injection site soreness for several hours, then abrupt onset of full body aches, chills, sweating, and fever. Symptoms lasted for ~30 hours.
This 96 year-old man was found on the floor of his home in the morning after he rolled and fell out of bed (height 1 to 2 feet) and was unable to pull himself back into bed. Because of somnolence and difficulty speaking, he was transported to the Emergency Department. His medical history was significant for recurrent mechanical falls, chronic obstructive pulmonary disease, obstructive sleep apnea, benign prostatic hypertrophy requiring intermittent catheterization, paroxysmal atrial fibrillation on anticoagulation, well-documented mild neurocognitive decline, and receipt of a bivalent COVID-19 booster injection the previous day. He was tachypneic (respiratory rate in the 30?s) and hypoxemic requiring supplemental oxygen at 2 L/min (no O2 at baseline). A chest radiograph showed right lower lobe reticulonodular opacities concerning for aspiration or pneumonia. He was given IV fluids and treated with ceftriaxone and azithromycin in addition to his usual maintenance medications. He was evaluated by neurology and physical therapy specialists. Over the ensuing 36 hours he improved to his usual baseline. He was discharged in medically stable condition to his home with follow-up health care plans in place, including visiting nurse service.
This spontaneous report as received from a registered nurse refers to a 5 months old female patient. The patient was vaccinated with dose 1, oral, ROTATEQ (lot # not reported) on 30-APR-2012. The patient was receiving dose 2, oral, ROTATEQ (lot # not reported)n 27-JUL-2012. No adverse experience had been observed or reported. Additional information has been requested.
12/20/22 presents to ED for "worsening dizziness". PMHx of "DM, HTN"
Evening of September 14, I was exhausted and went to bed at 7 pm. Slept several hours and woke up with muscle ache. I proceeded to have fevers, chills, muscle aches, runny nose for about two weeks. I could not complete temperature checks for about a week after symptoms resolved because I was taking NSAIDS for menstrual cramps. I completed no fever temperature checks on or around September 29
swelling, very painful, and itching lymph nodes.  Sporadic Inability to focus, or maintain balance. Pain increases when turning head and speaking.
Within 10min patient first experienced feeling hot and tightening of throat. Patient visibly sweating on forehead. Patient expressed feeling extremely flushed. No meds given per patient request. 30 min post-vaccination, patient now feeling very cold, throat feels better but still a little tight, and a little dizzy. No nausea.
Patient called to inform me that he needed to get MMR for his job but was given MENACTRA. The titers showed no immunity until the nurse looked at the form given.
Patient called and reported that within 30 min of vaccination she experienced "nerve pain". She was calling about 1 month post vaccination and still having issues using arm.
Patient developed bruising on day 2 after the vaccine, with increasing pain each day. Redness and swelling appeared on day 8. Patient was diagnosed with cellulitis at the injection site and placed on antibiotic treatment (cephalexin).
Red raised rash on chin and lip area.  2 days later started to stutter when he spoke.
Starting about 5 minutes after receiving the vaccine, I felt feverish (no fever), lightheaded and dizzy. The doctor on site had me wait for an hour until I felt well enough to drive home. Over the next several hours, my lightheadedness became so bad I felt as though I would faint if I stool for longer than a few minutes. On Saturday, 2-13-21, I did pass out on the stairs and again in my livingroom. On Sunday, 2-14-21, I decided to go to urgent care in which I was told to "wait it out". However, my symptoms had gotten worse over the last couple days to include body aches, headaches, muscle/joint pain, congested sinuses, slight cough, and feeling feverish (no fever) along with being dizzy. Therefore, I went to the ER later that morning 2-14-21, to see if I could get better treatment for my symptoms. I received IV fluids and they preformed blood work, a urinanalysis and an ECG. I was released from the ER around 8pm. My symptoms were better for the remainder of the evening, but have gone back to what I was feeling before for the last several days. My symptoms have been unresolved now for 1 week. I am getting tested for COVID-19 on Saturday 02-20-21.
5 1/2 cm across by 2 1/2 cm longitudinal, non-tender, non-indurated redness posterior aspect of mid-upper arm on left.
The am after his 1st immunization he awoke with right ulnar neuropathy. No preceding injury. He is going to require surgery. It is possible that epitrochlear lymphadenopathy caused this but not the only possibility. It could have been compression from sleeping wrong that caused the symptoms.
PER PHONE CONVERSATION FROM PATIENT ON 10/2/18 AT 3:22PM PATIENT REPORTED SWELLING NEAR HER LEFT ELBOW. SHE SAID SWELLING AND PAIN STARTED NEAR INJECTION SITE 9/30/18 (NEXT DAY AFTER SHE GOT THE SHOT) SWELLING TRAVELED TOWARD ELBOW EACH DAY. BY THE TIME OF REPORT SHE SAID SWELLING SIGNIFICANTLY GOT BETTER AND NOT PAINFUL.
The adverse symptoms my child received after the MMR injection was a huge rash all over his body then 5-days later, loss of speech & gastrointestinal difficulties, & loss of social withdrawal-autism.  5/29/2008 Multidisciplinary eval received dated 3/31/2008 with DX:  Speech Delay, Developmental Delay, PDD-Nos. On the Bayley Scales of Infant Development pt scored in the upper limit of moderately autistic range of autism spectrum disorders. Initially referred due to lack of speech aquisition (report states child has had no meaningful speech) but also had cognitive and social abnormalities.  /20/2008 Office records received from PCP with normal WCC 10/25/06. on 5/3/07 WCC Assessment:Well child. WCC 10/29/07 with vocab of 10 words at 2 yr check. Language delay noted at 2/28/08 visit. Follow-up: The residual symptoms that are related to the vaccine shot patient received are loss of speech and a regressive developmental disorder. Patient has pervasive developmental disorder not otherwise specified <PDD-NOS> known as autism spectrum. Patient received one hundred and twenty-five times his allowable exposure to mercury from vaccines in a single day.
covid vaccine  breakthrough  dose 1 2/28/21  025A21A dose 2 3/24/21  045A21A dose 3 9/1/21  050C21A
4 days after second Pfizer Vaccine, I started having persistent tinnitus in my left ear that interfered w my ability to sleep
Information has been received from a consumer referring to his/her daughter, a 5 year old female patient. The patient's concurrent condition, medical history and concomitant medication were unknown. In July 1993 (reported as 25 years ago), the patient received VARIVAX (dose, route, lot number and expiration date unknown) for prophylaxis. Then on an unknown date in July 1993 (reported as 25 years ago), the patient had vasculitis of blood which caused kidney damage. The outcome of the events was unknown. The causality assessment was not provided by reporter. Upon internal review, vasculitis of blood and kidney damage were determined to be medically significant.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 01-FEB-2013, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions was reported for the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of ZOSTAVAX lot # L006381, expiration date 25-MAY-2016 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8735) and on 23Apr2021 as dose 2, single (Lot number: ER8735) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Oct2021 as dose 3 (booster), single (Lot number: 035C21A) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clarithromycin, reaction(s): "Known allergies clarithromycin". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Negative, notes: tested negative on rapid antigen testing; (13May2022) Negative, notes: Tested negative again on day 11; (17May2022) Positive, notes: new positive antigen test.Brand: Paxlovid ,Treatment start date:02May2022, Treatment Stop date:06May2022,Indication:Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Vaccination failure, COVID-19 cannot be completely excluded.
Vaccine injection was administered at 10:15am 6/18/14. 10:17am 6/18/14 patient had a reaction, eyes rolling, patient sweaty patient was near syncope. Patient was stable in 5 seconds. Vital signs temperature 99.4 BP 100/60 mmHg, pulse 82 b/m, Resp. 16. Patient ate popsicle and waiting 30 mins. Was fine and stable. Patient left with mom. No further intervention needed.
My left arm that I received the injecton in started to hurt the feeling with like a numbing pain it felt like it was swelling even when it didn't, matter waht I did to find comfort it didn't help; I ran a fever that felt like my body was on fire especially the left arm where I received the shot; and I also experienced hives in my left arm that rar acroos to my other arms, hands, legs and back. I also began to experience headaches that lasted through out the day.
enlarged nodules on left side of neck; large rash on left arm at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of   in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.