chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clots on lungs/Pulmonary embolism; Inappropriate route of administration; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots on lungs/Pulmonary embolism) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 31-Aug-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of administration). On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots on lungs/Pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 09-Sep-2021 due to PULMONARY EMBOLISM. On 31-Aug-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of administration) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood clots on lungs/Pulmonary embolism) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       Concomitant medications include 1 daily dose of unknown Blood pressure meds.  No treatment medications are reported.  Company comment- This case concerns a  69 year-old male patient, who experienced the unexpected event s of Inappropriate route of product administration and Pulmonary embolism. The event of Pulmonary embolism occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  69 year-old male patient, who experienced the unexpected event s of Inappropriate route of product administration and Pulmonary embolism. The event of Pulmonary embolism occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
About  two weeks after booster shot got incredibly sick out of no where with fever of 103 and body aches . Got admitted to hospital due to heart issues.  Never had heart issues before and now been diagnosed  with Cardiomyopathy. Doctors state they have no idea how I would have got this could be viral. Tested negative for covid
Suspected COVID-19 virus infection  Acute upper respiratory infection  Disturbances of sensation of smell and taste
After the vaccine I have strong bleeding liked my period was really heavy. January & February My period disappeared. 2 months no period.
could not move and she could not bend when she got up; she could not sleep or lay down as she normally does; Dizziness; head spinning/ vertigo; Nausea; pain in her arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE ER) and OXCARBAMAZEPINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm) and CHILLS (Chills). On 14-Mar-2021, the patient experienced DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo) and NAUSEA (Nausea). On an unknown date, the patient experienced HYPOKINESIA (could not move and she could not bend when she got up) and INSOMNIA (she could not sleep or lay down as she normally does). At the time of the report, PAIN IN EXTREMITY (pain in her arm), DIZZINESS (Dizziness), VERTIGO (head spinning/ vertigo), HYPOKINESIA (could not move and she could not bend when she got up), INSOMNIA (she could not sleep or lay down as she normally does), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
High fever, chills, malaise, headache, muscle aches, injection site soreness.
At 3:30 PM, Patient experienced light-headedness (syncope) after leaving clinic site. Dad helped his son, Pt to ground just outside of clinic tent. Brother ran back and found ARNP to assist. She performed vitals on patient: Pulse: 52, BP 80/0. EMS was contacted immediately at 3:33 PM by myself, PharmD.  Patient returned  to shade on clinic tent, was able to ambulate on own. S/S: pale skin color, mildly diaphoretic. At 3:39 PM, EMS Medics arrived at scene and assessed patient. Patient was able to walk to fire truck and drink water. Patient was released at approximately 4 PM, returning home with his Dad and brother. I spoke to Dad, patient and EMS, patient was stable and discharged from EMS care. Patient walked over to car with brother.
I had a severe migraine - and I don't have headaches. My whole face hurt.  (I have two optic aneurisms and I was afraid they were starting to bleed out.) My eye was running water even more at that point and I also had some mucus in my eye. I went to ER.  January 8 and they did a CT scan - and they gave me something IV for pain. They told me to take extra strength Tylenol every four hours and that didn't help. After one hour, I was in severe pain again. At that point, both eyes were tearing. I went to the dentist (Monday)  -and they did x-rays - (  to see if I had a tooth issue and I went to my ENT doctor  (Tuesday)- and he said it didn't appear that I had a major infection.  still in severe pain - she gave me a prescription to get rid of infection in my eyes. She gave me a steroid shot - which stopped the pain. The following week, I had an appt with an ophthalmologist- I was not in pain any more and my eyes had pretty much cleared up. He said I probably had a viral or bacterial infection prior and when I got the vaccine then that was why I got a migraine.  2nd vaccine - 30th of January (8:30) - I slept all that day - I was sleepy the whole day and the Sunday, I had flu like symptoms and after that I was fine. This week, I have the infection in my eyes again. I went back to the Dr yesterday to get an antibiotic because I was having the same kind of infections. This time - infection in my left eye, with tearing and mucus. They had me do the eye drops again and nasal spray I've been using.
After vaccine experienced, next day, site ((L) deltoid) soreness, aching pains all body joints (especially shoulder jts and scapula, and both hips, B/L knees, ankles, calves and feet and anterior shins) with associated extreme fatigue - all over last 4 weeks. ADVIL helps a little.
Gradual dysautonomia symptom complex developed in 2008 after receiving 8 vaccines, also sustained electric shock episode. Now diagnosed with small fiber neuropathy and is undergoing medical separation from employment. Vaccination history 2008: 10 Feb: Typhoid vl, Hepatitis B #1, Anthrax #3; 1 Mar: Anthrax #4; 5 Apr: Varicella, Hepatitis B #2; 29 Aug: Anthrax #5; 9 Sept: Intranasal Influenza; 5 Oct: Hepatitis B #3. Symptoms: Dizziness and giddiness, Disturbance of skin sensation, Palpitations, Shortness of breath, Symptom, nervous/musculoskeletal NEC, Symptom, memory loss, Malaise and fatigue.
Patient reported that a day after receiving MMR on right arm subcutaneously, he experienced pain with right elbow extension and supination.  He is point tender only over the right lateral epicondyle but no swelling, erythema, or warmth is noted on exam.  He has been taking ibuprofen as needed (2-3 times per week), resting, and applying a muscle rub.  He is still able to work despite the pain.  He has not followed-up with anyone regarding this.  He states that his pain has remained stable despite his self treatment.  He denies doing anything strenuous around the time of vaccination that could have precipitated the pain.
Mother states child's right arm was swollen 3 times it's normal size and swollen up in the Right side of child's jaw.
Now has a localized injection site reaction; Now has / blurred vision in his right eye.; This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2021, the patient received the 2nd dose of Shingrix. On 30th June 2021, 2 days after receiving Shingrix, the patient experienced injection site reaction and blurred vision. On an unknown date, the outcome of the injection site reaction and blurred vision were unknown.   It was unknown if the reporter considered the injection site reaction and blurred vision to be related to Shingrix.  Additional details were reported as follows: This case was reported by a physician. The physician reported that, the patient received his second dose of the Shingrix Vaccine. The patient experienced a localized injection site reaction and blurred vision in his right eye. The reporter does not know the lot number or expiration dat e of the vaccine the patient received. Did not consent to follow-up.
received an expired second dose; second dose >35 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Bad headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 43; unspecified unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 15Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first vaccine this morning (15Jan2021) and has a bad headache. The patient was calling to see how long side effects usually last and if the second shot will be worse. The patient also asked if she can take paracetamol (TYLENOL) for it and if she can use antipyretics before or after vaccination with the COVID-19 vaccine. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
The patient was supposed to have Tdap and flu shots, but instead of giving her the Tdap, she was given HPV vaccine by medical assistant.  pt was 31 6/7 weeks pregnant at time of vaccine, EDC 11/7/20.  no other info available about fetus at this time.  she had swelling of right upper arm, which resolved
severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (severe heart pain/chest pain/left side chest pain/back pain/unable to lie down/pericarditis) outcome was unknown.            No concomitant medications were reported. It was reported that when the patient got her 3rd Moderna Covid-19 vaccine dose, a week after she experienced: chest pain, left side chest pain, back pain, severe heart pain, and she was not able to lie down. She went to ER and they run studies and was diagnosed with Pericarditis. She contacted her cardiologist but he said that he did not had guidance on how to proceed with her vaccination.  No treatment information was provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the expected serious (medically significant) AESI of Pericarditis which occurred approximately 1 week after administration of third dose of mRNA-1273. Patient experienced left chest pain, back pain, she was not able to lie down, she went to emergency where she was diagnosed with pericarditis after investigations. Details of primary doses of vaccination, medical history, concomitant medications, clinical course, treatment, and investigations were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the expected serious (medically significant) AESI of Pericarditis which occurred approximately 1 week after administration of third dose of mRNA-1273. Patient experienced left chest pain, back pain, she was not able to lie down, she went to emergency where she was diagnosed with pericarditis after investigations. Details of primary doses of vaccination, medical history, concomitant medications, clinical course, treatment, and investigations were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient warned staff that she was not good with shots and had a history of syncope. She also marked this on her VAR form. She was very nervous and crying in the chair. She received the vaccine promptly and remained in the chair for a few minutes before getting up to sit in the auditorium bleachers. after about 20 or more minutes someone shouted that saw her fall in the bleachers, she was face down between the benches. She was conscious and responding, breathing normally, with normal pulse when we examined her. She got up slowly and recovered without needed further medical attention.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 10-DEC-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
This spontaneous report was received from an office manager and refers to a 75 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. She had no known allergies. On 12-JUN-2018, the patient was vaccinated with a properly stored dose of PNEUMOVAX 23, 1 injection intramuscularly in the left deltoid for vaccine prevention (lot # R009408, expiration date 07-MAR-2020). On 14-JUN-2018, the patient noted that her left arm became "swollen, warm and itchy with purple/red markings noted from the armpit down to the elbow". On the same day, the patient was seen in the physician office. She received unspecified antibiotics as treatment and no laboratory tests were performed. At the reporting time, the patient was recovering from Peripheral swelling, erythema, pruritus and feeling hot. The causality between the events and PNEUMOVAX 23 was not reported. The reporter requested a lot investigation. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA006939.
Nausea; Injection site pain; Light sensitivity with his eyes. When he left facility, he felt that everything was very bright; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Light sensitivity with his eyes. When he left facility, he felt that everything was very bright), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PHOTOPHOBIA (Light sensitivity with his eyes. When he left facility, he felt that everything was very bright) and HEADACHE (Headache). On an unknown date, the patient experienced NAUSEA (Nausea) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, PHOTOPHOBIA (Light sensitivity with his eyes. When he left facility, he felt that everything was very bright), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment information was specified.
Severe body aches, dizziness, nausea, headache. Started approximately 10 hours after vaccination. Rest, Tylenol, Naproxen, fluids.
My arm immediately began to itch and develop hives. Soon after my chest became tight and I had trouble breathing
Pfizer-BioNTech COVID-19 Vaccine EUA Received 2nd dose of the pfizer vaccine on 10/12/2021, Symptoms such as fever with chills on and off, the first night/next day following 2nd dose of the pfizer vaccine, with headache, as well as body aches. Acetaminophen and Ibuprofen were rotated to help with fever/body aches. On the 10/14/2021 and now 10/15/2021 experiencing welts/hives as well as persistent neck pain and headache. Some of the hives/welts resolved with BENADRYL. Some hives still remain as well as the headache and aches.
Severed headache starting 12 hours after injection, pain, better after 24 hours, fatigue continued for 5 daya post injection.  Swelling at injection site for 3 days following injection. Day 8 injection site became swollen, hot itchy, arm is sore and continues to be an issue.
patient was bedridden for 4 days, requiring use of walker to move about her home, starting the morning following the shot.  Pain all throughout the body, fever and chills, and couldn't eat for 3 entire days.  Patient describes it as horrific experience.  After day 4 she said she felt good after waking up and the symptoms fell off. Patient describes (2 weeks later now) feeling "weird again" and "doesn't feel right" with off and on fever.
After receiving MMR and IPV, began to feel nauseated and dizzy. Symptoms persisted and facial swelling started. No SOB or breathing problems. Was seen in ED; symptoms were abating on own; given Benadryl and symptoms resolving.
Patient called back after an hour of being vaccinated saying that she has tingling and numbness of the tongue.
report a reaction to the moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report a reaction to the moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (report a reaction to the moderna vaccine). At the time of the report, VACCINATION COMPLICATION (report a reaction to the moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: Lohitha Pallerlamudi AE submitted via Chatbot  Patient had received Moderna vaccine and experienced a reaction to the Moderna vaccine.  No allergies, lab data, medical history was reported y patient. No concomitant and treatment medication was reported by patient. Consent to follow up with safety was unknown.; 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.
I had sore throat, congestive, cough, and running nose. I had a mild fever. I was fatigued, back pain, and body pain. I had dizziness, diarrhea, and nausea. I have burning eyes, memory issues, and insomnia. I have a headache that never goes away. I had slight difficulty breathing at night. My throat swelled up a little bit. I went to an urgent care. I got 2 prescriptions. They did a COVID-19 test, positive result. These symptoms have been since October 31.
pt became diaphoretic, weak, and pale.  BP 88/56, Pulse 84, O2 95%. On reassessment a few minutes later, BP 108/80, Pulse 77, O2 99%. pt was checked by physician who determined he was allowed to leave.
pt recvd vax;2 mon p/ vax she broke out,had 12-14 pox marks around site of inject;