chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches; chills; fever (about 101.5 temp); body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), CHILLS (chills), PYREXIA (fever (about 101.5 temp)) and PAIN (body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle aches), CHILLS (chills), PYREXIA (fever (about 101.5 temp)) and PAIN (body aches). At the time of the report, MYALGIA (muscle aches), CHILLS (chills), PYREXIA (fever (about 101.5 temp)) and PAIN (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 °F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Company Comment  This case concerns a patient of unknown age and gender, with PMH of COVID-19, who experienced nonserious expected events of pain, fever, chills, and myalgia.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
acute Ischemic stroke; Information has been received from a lawyer, regarding a case in litigation, and refers to a male patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. In or about 26-JUL-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prevention of shingles (herpes zoster) (prophylaxis). Shortly after the receipt of zoster vaccine live (ZOSTAVAX) vaccine, the pt experienced left sided weakness, slurred speech, arm and facial droop and was diagnosed with an acute ischemic stroke. As a direct and proximate result of the administration of this vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well a significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of the report, the pt had not recovered from the event. The reporter considered the event to be related to suspect therapy and disabling.
REDNESS, ITCHINESS AT INJECTION SITE, ABOUT 1.5-2 INCHES IN DIAMETER, WARM TO THE TOUCH. TAKING BENADRYL, TYLENOL AND APPYING ICE PACK EVERY 15-20 MINUTES.
Headache; This is a spontaneous report received from a contactable consumer reported for a patient as per the FDA Guidelines for Post marketing Reporting of Adverse Drug Reactions (Docket No. 85D-0249) dated Mar1992 (Part VI, I).   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: not reported), via an unspecified route on an unknown date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache. It was unknown if the patient received any treatment for the events. The clinical outcome of the event headache was reported as unknown.  Follow-up needed. Information about batch/lot number has been requested.
No appetite; Achy body; Nausea; chills; little headache; Fever; Sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), PAIN (Achy body), NAUSEA (Nausea) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Achy body), NAUSEA (Nausea), CHILLS (chills), HEADACHE (little headache) and PYREXIA (Fever). On 15-Feb-2021, the patient experienced DECREASED APPETITE (No appetite). On 16-Feb-2021, PAIN IN EXTREMITY (Sore arm), PAIN (Achy body), NAUSEA (Nausea), CHILLS (chills), HEADACHE (little headache) and PYREXIA (Fever) had resolved and DECREASED APPETITE (No appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient took an unspecified migraine medication for the treatment of the events.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Reporter e-mail added.
Reports history of polyuria, polydipsia, fatigue and intermittent visual changes dating back to the summer of 2005. Initially, he did not necessarily feel sick, but noted he was not feeling himself. Symptoms gradually increased and in March 2006, he sought evaluation. Records review reveals he presented on 17 March 2006 with a serum glucose level of 487 and negative urine Ketones. He was diagnosed with Type 2 diabetes and started on METFORMIN. His blood glucose levels were in good control on oral agents and meal planning for about 7-9 months. After persistent suboptimal glycemic control despite adjustments in oral agents, positive Gad-65 antibodies and several low C-peptide levels, his diabetes was reclassified as Latent Autoimmune Diabetes in Adults (LADA) in February 2007. Prior to diagnosis of diabetes, he denies a history of elevated glucose or blood pressure levels or history of hypertension. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active and met weight and PT requirements prior to diagnosis. He has no family Hx of T1 DM. He is on status after undergoing a medical board in 2007. He is currently controlling his diabetes using an insulin pump and continuous glucose monitor. He denies long-term diabetes-related complications except for for peripheral neuropathy. He also has had chronic problems with onychomycosis since being diagnosed with diabetes.
Information has been received from a pharmacist concerning a male patient who on 08-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot# 655669/1128F). On approximately 09-NOV-2007, within 24-48 hours of receiving the vaccine, the patient developed pain, swelling, and cellulitis. Recovery status of the patient was not reported. The patient sought unspecified medical attention. It was reported that this patient may be a liver failure patient. Additional information has been requested.
Sharp pain under right breast that goes from front to back. Under  side of right breast is tender and heightened sensitivity.  Top of breast is fine.
fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigued".  Additional information: Caller said that her son got the second dose already and her son is feeling very tired and fatigued after his second dose. Caller is asking if her son can take Tylenol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site rash, mild fever and flu like symptoms. Rash still present on the 3rd day but not painful or itchy
Systemic: Dizziness / Lightheadness-Mild, Systemic: pt described a vibration in his head, visual disturbance-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild
- itchy, reddish bumps around injection site. No other symptoms. Benadryl 25mg q 6 hours, hydrocortisone Cream, cool packs.
A couple of hives were noticed on patients lower left leg on 9/24. Upon walking on 9/25 many hives were noticed on the patients upper left thigh (site of injection) as well as upper right thigh and lower right leg. Hives were itchy and 5 mL of  Zyrtec was administered. Patient also has a low-grade fever.
I had a fever, stomach pain ache, fatigue, mild cough, body aches, diarrhea, and shortness of breath on exertion. When I eat, the food increases the pain in my stomach. This lasted for about 10 days, I would like to add this about my 3rd dose: I got the injection in my left arm, but I have had a lingering discomfort in my arm from time to time at the injection site in my arm.
His friend has four friends that were in their early 50s that had mild strokes after the vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "His friend has four friends that were in their early 50s that had mild strokes after the vaccine.".  Clinical course: Case was assessed as non-serious by the reporter. The day after he could only bike 8 miles in two hours.He used to be able to bike up to 30 miles no problem, but now he struggles with short distances. His heart can't take it. If he does do a long bike ride, he has to sleep until 6pm the next day, he is just absolutely exhausted. He has been to the ER at least five times. He is scheduled to see a cardiologist but can't get an appointment until Aug. Now he has a nagging numbness that goes up and down from his elbow to his shoulder and then it'll go away. On the one year anniversary of the shot 04Jun2022 he had sharp pains to the heart. He thought he had severe asthma and that's why he wanted to get the vaccine. His friend had to be helicoptered to (withheld) for a massive heart attack after taking the vaccine. A friend of his, a 39 year old athlete, is having problems after the vaccine and the doctor says its all in her friend. His friend has four friends that were in their early 50s that had mild strokes after the vaccine.  No follow-up attempts are possible. No further information is expected
Pt inadvertently given MMR #3, instead of Varivax #2 no physical signs/symptoms
Information has been received from a physician concerning a 9 week old male, with no medical history and no allergies, who on 06 Dec 2006 was vaccinated with a first oral 2 ml dose of Rotateq (human bovine) (Lot# 654248/0577F). Concomitant vaccines administered on the same day  included a dose of Pediarix, a dose of Pedvaxhib and a dose of Prevnar. On 11 Dec 2006 or 12 Dec 2006 the patient experienced diarrhea. The patient had no diarrhea on 17 Dec 2006 or 18 Dec 2006. At the time of the report the patient was recovering. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Addition information has been requested.
eclampsia; Deep vein thrombosis on her right leg/ blood clot; scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ECLAMPSIA (eclampsia) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included NIFEDIPINE (PROCARDIA [NIFEDIPINE]) and LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 20-May-2021. On 12-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 09-Jun-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy). On an unknown date, the patient experienced ECLAMPSIA (eclampsia) (seriousness criterion medically significant) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 12-May-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 09-Jun-2021, INTENTIONAL PRODUCT USE ISSUE (scheduled for second shot on 09-Jun-2021 but did not receive due to complications with pregnancy) had resolved. At the time of the report, ECLAMPSIA (eclampsia) and DEEP VEIN THROMBOSIS (Deep vein thrombosis on her right leg/ blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  The reporter stated that while screening for 2nd dose that was scheduled for 09-Jun-2021, patient checked yes for blood thinner and blood clot.  Company Comment  This is a case of product exposure during pregnancy and intentional product use issue with associated AEs of eclampsia and deep vein thrombosis reported for this 40-year-old female. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of product exposure during pregnancy and intentional product use issue with associated AEs of eclampsia and deep vein thrombosis reported for this 40-year-old female. Very limited information regarding these events has been provided at this time. Further information has been requested.
herpes zoster shortly after vaccination; Information has been received from a lawyer regarding a case in litigation concerning currently an approximately 58-year-old female patient (pt). No information was received regarding the pt's medical history, concurrent conditions and concomitant medications. The pt was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider. On or about 05-OCT-2015, the pt was administered zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, anatomical location and route of administration were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a provider(s) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster shortly after vaccination. The outcome of herpes zoster was unknown. The reporter considered the event of herpes zoster shortly after vaccination to be related to zoster vaccine live (ZOSTAVAX).
On 9/20, patient developed fatigue, vomiting, and weakness. On 9/23 she had a fever of 103 F so was brought into the ED by her family. Patient had tested negative for COVID at her senior living facility however tested positive for COVID in the ED. She additionally had right leg cellulitis and associated swelling and pain to the legs and ankle. She was admitted from 9/23 - 9/27 with discharge diagnoses including COVID-19 infection with superimposed right lower lobe bacterial community-acquired pneumonia and sepsis secondary to right lower lob pneumonia and right lower extremity nonpurulent cellulitis. Patient has received the COVID vaccine and one booster.
Expired ANTHRAX administered. Lot FAV231, Exp date 4Oct10. Given 16 Oct 10. No adverse reaction noted.
Information has been received from a physician concerning a 12 year old female who was vaccinated with one 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 658000/0845U). The patient developed redness, warmth and swelling at the injection site. The dimension of the swelling was 2 and 1/4 inch by 1 and 1/2 inches. The patient contacted the physician. The outcome is recovering. No product quality complaint was involved. No further information was available. This is three cases reported by the same source. Additional information has been requested.
Patient reported slight swelling in L armpit morning following immunization.  Also swollen nodes at base of neck and stiff neck; tender/swollen L breast.  No treatment at time of reporting.
Eye swelled up; FEELING HORRIBLE; Heart palpitation came on suddenly; Shortness of breath; Fatigue is continuous; Muscle aches; Pains in the joints; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath) and FATIGUE (Fatigue is continuous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event and COVID-19.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue is continuous), MYALGIA (Muscle aches) and ARTHRALGIA (Pains in the joints). At the time of the report, EYE SWELLING (Eye swelled up), FEELING ABNORMAL (FEELING HORRIBLE), PALPITATIONS (Heart palpitation came on suddenly), DYSPNOEA (Shortness of breath), FATIGUE (Fatigue is continuous), MYALGIA (Muscle aches) and ARTHRALGIA (Pains in the joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Maternal exposure during pregnancy; The newborn is in the NICU; This is a spontaneous report from a contactable consumer (parent) via a Pfizer sales representative. This consumer reported information for both mother and fetus/baby. Thi is the fetus/baby rpeort. Only this case is serious. A fetus of an unspecified gender received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via transplacental route of administration on unspecified dates as single dose for COVID-19 immunisation. The patient experienced maternal exposure during pregnancy and premaure birht at 25 weeks (the newborn is in the NICU) on an unspecified date. The events were considered serious as life-threatening. Birthweight was 1.96 pounds. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020513513 Same reporter/ drug, different patients/ events;US-PFIZER INC-2021412709 Same reporter/ drug, different patients/ events
getting a lot of pain on his lower rib at the back and on the side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 23Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL CHEST PAIN (non-serious), outcome "unknown", described as "getting a lot of pain on his lower rib at the back and on the side".  Additional information: It was reported as, they were called in because he got the 1st dose of the vaccine on 23Apr2021 and he said he was getting a lot of pain on his lower rib at the back and on the side. He wants to know if it was a side effect of the vaccine and if there were reported side effects like this after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came back in to the pharmacy about a week after his vaccination. He let us know that he experienced significant decreased function in his left arm for about a week after the vaccination.  Patient explained that it was difficult to move his arm. It has since subsided.
Headache; sore arm; This is a spontaneous report received from a contactable consumer (patient himself). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: EJ1685) via an unspecified route of administration in left arm on 04Mar2021 at 15:30 (at the age of 48-year-old) for COVID-19 immunisation. Medical history included allergies to tartrazine, gluten and penicillin. Concomitant medications were not reported. Patient previously took ciprofloxacin, differin and tessalon perle and experienced with allergy for all. On 04Mar2021 (stated within 1 hour of receiving vaccine) patient had headache and on an unknown date in Mar2021 (after first dose), patient had sore arm. Treatment was not received for the adverse events. Outcome for the event headache was not recovered and was unknown for sore arm.
Urticaria to arms started on the eve of December 20, 2020, took benadryl and applied triamcinolone ointment to rash, woke up and found more rash all over the body took benadryl again, after an hour of taking the benadryl, my face started to itch, that;s when I went to the ED where they gave me, a steroid IV , Benadryl  IV and Pepcid IV.
extremely sore left injection site arm; swollen lymph nodes in her left arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (extremely sore left injection site arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in her left arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunosuppressed).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (extremely sore left injection site arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in her left arm). At the time of the report, VACCINATION SITE PAIN (extremely sore left injection site arm) and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes in her left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient received the first dose of vaccine in her right arm shoulder deltoid muscle. The patient had no adverse reactions after the first vaccine.  The patient received the second dose of vaccine in her left arm shoulder deltoid.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-466240 (Patient Link).