chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist, concerning her 20 year old daughter, who in November 2007 ("about 2 weeks ago"), was vaccinated with the first dose of HPV vaccine (lot #not reported).  Concomitant therapy included fexofenadine hydrochloride (Allegra).  In November 2007, following the vaccination (duration onset not reported), her daughter developed a case of mild shingles, and was seen by the college physician.  At the time of this report, the patient was recovering from the event.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/14/2007. Initial and follow up information has been received from a pharmacist, concerning her 20 year old daughter, a student with mild and well-controlled asthma, who in November 2007 ("about 2 weeks ago") , was vaccinated with the first dose of GARDASIL (lot # not reported). There was no illness at the time of vaccination. Concomitant therapy included ALLEGRA. In November 2007, also indicated as "about 3 weeks after administration of vaccine" her daughter, who was otherwise healthly, developed a case of mild shingles and was seen by the college physician. At the time of this report, tthe outcome of the event was unknown. Additional informafon is not expected.
Information has been received from a health professional concerning a 4 month old patient who was vaccinated once with a 2 mL oral dose of rotavirus reassortant vaccine live (human-bovine). The patient had no adverse reaction. It was reported that the patient came back and received their second dose of rotavirus reassortant vaccine live (human-bovine). No product quality complaint was involved. No other information was provided. Additional information has been requested.
pt recvd vax; w/in 2 days exp antigenemia;positive HBSAG
Information has been received from a 66 year old female patient with a history of shingles and no known drug allergies, who in December 2006, was vaccinated in the left arm with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included OTC vitamins (unspecified) and BIOFLEX. In January 2007, the patient experienced injection site pain. The patient stated that some days are better than others but the pain had never subsided. The patient sought unspecified medical attention. Additional information has been requested.
March 5th left side of face started twitching lasted all weekend.   Headaches, arm pains, chest pains, tingling of toes and hands, numbness of  tip of tongue started March 8th, 2021.   Currently  3/21/2021 my face is tingling continuously with small twitches from time to time.   Headaches off and on lasting about 4 hours.  My right eye hurts, feels like electrical shocks to my head and scalp of my head periodically.
Complains of dizziness, trouble focusing, and feeling ill. 1205 BP 120/80, pulse 83. 1214 BP 140/40, pulse 94. Provided O2 via nasal cannula. Transported to emergency department.
Extreme faitigue/exhaustion, moderate but lingering headache, lasting approximately 36-48 hours
Patient is fully vaccinated and boosted.  COVID positive 2/17/2022 on admission to hospital. 79-year-old male with a history of follicular lymphoma, umbilical and inguinal hernia, hypertension, diabetes who presented with worsening shortness of breath and abdominal discomfort.  Patient stated that shortness of breath started a month ago.  Patient reports being diagnosed with Covid last month. Patient states that he lost appetite and he experiences abdominal discomfort after eating. Per EMS, oxygen was 88% upon arrival.  Patient is status post thoracentesis and paracentesis for acites  and patient condition improved. Treatment: oxygen,  IV decadron, Breo inhaler, alberterol for pneumonia. Recent 2-D echo with bubble study revealed pulmonary AV malformation. D-dimer, elevated given IV heparin. Patient discharged with home O2.
Fever or Chills; Fatigue; Muscle or body aches; Headache; Sore throat; Congestion or running nose.
leg did have to get stitches; fainted in the shower; felt a little dizzy; fell to the ground/collapsed/fell over again; hit my knee on the tile; beyond dizzy/took me a half hour to get up; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainted in the shower) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SYNCOPE (fainted in the shower) (seriousness criterion medically significant), DIZZINESS (felt a little dizzy), FALL (fell to the ground/collapsed/fell over again), JOINT INJURY (hit my knee on the tile) and DIZZINESS POSTURAL (beyond dizzy/took me a half hour to get up). On an unknown date, the patient experienced LIMB INJURY (leg did have to get stitches). At the time of the report, SYNCOPE (fainted in the shower), DIZZINESS (felt a little dizzy), FALL (fell to the ground/collapsed/fell over again), JOINT INJURY (hit my knee on the tile), DIZZINESS POSTURAL (beyond dizzy/took me a half hour to get up) and LIMB INJURY (leg did have to get stitches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The first shot she didn't have a reaction. On 12Feb2021, she felt a little dizzy after she got up in the morning. Then she fainted in the shower. She collapsed and fell to the ground. She never fainted in her life. She hit her knee on the tile and crawled out of the shower. But she fell over again because she was beyond dizzy. It took her a half hour to get up. She states it was a very weird fainting experience. The leg did have to get stitches. She states she lives alone. She states she has no major illnesses. She goes to the gym all the time.  She doesn't take any medications, except one for thyroid. The patient states that she doesn't know what to do now. She is concerned about taking the booster shot. She wants to know if she can take a Pfizer vaccine. Consent given for safety to contact the patient and her HCP. Treatment details were not provided.; Sender's Comments: This case concerns a 83 year-old, female with no relevant medical history, who experienced the unexpected events of syncope (and other non serious events). The event occurred approximately 1month and 2 days after the first dose and 2 days after the most recent dose (second dose) of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Event "syncope" Was auto-upgraded to serious by Auto-IME tool, but based on info avail and medical judgment the event was reassessed as non-serious.
Pt received pfizer x2 doses. Admitted to the hospital for AMS and was COVID+. Received one dose of remdesivir then went to room air. So no further remdesivir given . 3 doses of dexamethasone 6mg daily given inpatient.
pt returned to MD office stated had episode approx 4hr p/vax  where lips turned blue, was unresponsive, became limp lasted approx 1min dx by MD syncopal spell secondary to cyanosis secondary to crying;
I was 5 weeks 5 days  pregnant with a EDD of 9/17/2021 at the time of my 2?d covid19 vaccine on 1/20/21. On 2/8/21 I found out that my fetus stopped growing at 6w1d, documented on US without heartbeat in the ER. I had a spontaneous miscarriage on 2/9/21.
patient stated that every since she got her shot she was having numbness, and tingling pain in the arm she had recieved the shot on. She did not have any other symptoms aside from that.
severe intestinal cramping; Slight low grade fever; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe intestinal cramping), PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (severe intestinal cramping), PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with ACETAMINOPHEN for Slight fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (severe intestinal cramping) outcome was unknown and PYREXIA (Slight low grade fever), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
got a rash, mostly on my back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (got a rash, mostly on my back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (got a rash, mostly on my back). At the time of the report, RASH (got a rash, mostly on my back) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.
He was ill; Patient had his first dose; Tested positive for Covid; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had his first dose on 06Mar2021 and second dose will be 27Mar2021. On 17Mar2021, patient tested positive for Covid. He was ill and received a medication named Bamlanivimab that was used as treatment for Covid and that is for immune system and monoclonal antibodies. So, reporter was asking that the patient had tested positive for Covid, is he still going to receive the second dose? Also, knowing that the patient took that medication (Bamlanivimab), is he still going to receive the second dose? The patient underwent lab test on 17Mar2021 includes Covid Result: Positive. The outcome of events was unknown.
Redness / swelling / warmth tenderness to upper left arm and to left elbow. Occasional body chills and fever (not documented)
Pain to left chest with shot administration, lasted for an hour. Three days later reports malaise, redness and edema to arm.
Expired doses administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069821A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: The follow up information contains significant information due to suspect lot number updated.
Within 4 hours, had muscle aches, headache, chills, and fatigue as well as pain and redness at injection site. In the next 24 hours, developed a 101.5 fever, had trouble walking and hives/rash around injection site. Also had pins and needles pain in legs and arms and arthralgia. Developed muscle twitching in hands while asleep and cold barely open my eyes.
This spontaneous report as received from a pharmacist refers to his now 81 year old wife with no drug allergies/reactions. The patient's medical history included history of melanoma on back and shingles 3-4 times. 2 years ago, in approximately April 2012 the patient was vaccinated with a single dose of ZOSTAVAX, subcutaneous (dose unknown). Concomitant medications include a lot of medications. The patient experienced several shingles outbreaks on an unspecified date since receiving ZOSTAVAX and was successfully treated with unspecified antiviral medication after each shingles episode. The patient experienced a burning, itchy rash all over her back and breast for the last 3 months, in approximately January 2014. She had been evaluated by an unspecified allergist and an unspecified dermatologist at office. The physicians both stated that the rash "is not shingles" and prescribed skin moisturizer and topical cortisone cream. The outcome of burning, itchy rash all over her back and breast was reported as not recovered/not resolved. Additional information has been requested.
pt devel 4" x 6" reddened raised area on lt upper arm where Td was given;minimal itching;no fever; warm & painful to touch;
shoulder pain; acting strange; a dose of aPNEUMOVAX 23 at unspecified time in 2018 then an additional dose in PNEUMOVAX 23 on 06-OCT-2019; This spontaneous report was received from a medical assistant referring to a 69-year-old male patient. The patient's concurrent condition, medical history and drug reactions/allergies were unknown by the reporter. The patient's historical vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13). The patient's concomitant medications included influenza virus split virion 3v vaccine inactivated (FLUZONE) and zoster rgE vaccine (mammalian) (SHINGRIX). On an unknown date in 2018, the patient was vaccinated with a dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose #, route of administration, lot/batch # and expiry date were not reported) for prophylaxis. On 06-OCT-2019, the patient was given additional dose of pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose #, lot/batch # and expiry date were not reported) via intramuscular route for prophylaxis (inappropriate schedule of product administration). On 29-OCT-2019, the patient's wife reported that the patient was acting strange (abnormal behavior) and complained of shoulder pain (musculoskeletal pain). The patient sought medical attention and contacted unspecified clinician but it was also reported that no treatment was given for the adverse events. On an unknown date, the patient had blood work performed to check the international normalized ratio (INR) but the results of which was not provided. The reported adverse events were non-cancerous. There was no associated product quality complaint. It was reported that, the patient was doing fine (recovering). The reporter did not provide the causality assessment between the events and the suspect therapy.
Headache, Myalgia, Fever, NauseaVomiting, severe H/A, body aches, exhaustion, ST, clear rhinorrhea, nausea, decreased appetite, redness swelling injection site, fever
56yr old patient with history breast cancer, right shoulder arthroscopy (2017), Crohn's disease and other comorbidities presented to PCP on 9/5 for well visit. Patient endorsed weight loss without trying despite eating three meals daily, no nausea/diarrhea. MD ordered for PNEUMOVAX-23 and SHINGRIX vaccine to be administered. CMA prepared and administered PNEUMOVAX 23 vaccine IM in patient's right deltoid and SHINGRIX vaccine IM in right deltoid. Patient stated unable to receive vaccine in left arm (unknown reason). On 9/6, patient called PCP complaining of fever (100.8), nausea, and shivering. Patient took TYLEMOL and MOTRIN with some relief. Patient denied rash, shortness of breath, or heart palpitations. On 9/7, patient returned to PCP office. UA positive however, Urine culture grew mixed flora (suspected to be contaminated). Patient prescribed nitrofurantoin and ondansetron ODT for nausea. Patient with increased emesis after PCP visit and instructed to go to ED. Patient presented to Hospital on 9/7 with large red welts on right arm, arm soreness, nausea, vomiting, fever, body aches, and difficulty swallowing. Patient with noted bandemia (WBC = 15.8). Ultrasound normal, no abscess or fluid collection noted. Per admission note, symptoms most likely local inflammatory reaction from vaccine and post vaccine viral type syndrome which improved with antiemetic and antipyretic. Patient prescribed doxycycline 100mg BID x 6 days for possible cellulitis. Unknown of further follow up.
Information has been received from a registered nurse concerning a 6 year old female with allergies to penicillin, silver sulfadiazine and bee pollens, and an unspecified past medical history, who on 05-SEP-2001 was vaccinated with a first dose of Varivax. Concomitant vaccination included a first dose of MMR II (manufacturer unspecified). On 22-SEP-2006 at 17:10 the patient presented to the emergency room with breakthrough chickenpox on her torso and groin area, and fever. It was reported that the patient was in no acute distress and did not have a known recent exposure to chickenpox though she is in school. The patient was prescribed over the counter Benadryl for itching. The patient's medications at the time of chickenpox onset included Tylenol, Reglan, Prevacid, Zyrtec, and albuterol. The patient's vaccination history included: First, second, third, fourth and fifth doses of DTaP on 12-OCT-2000 (manufacturer unspecified) (lot # U0328BA 8/97), 18-DEC-2000 (manufacturer unspecified) (lot # U0328BA 8/97), 14-FEB-2001 (TRI-IMMUNOL) (lot # 464-305), 26-NOV-2001 (TRIPEDIA) (lot # U0537AB), and 03-DEC-2004 (INFANRIX) (lot # 634B2) respectively, First, second, and third doses of Comvax on 12-OCT-2000 (manufacturer unspecified) (lot # 1034K), 18-DEC-2000 (manufacturer unspecified) and 26-NOV-2001 (lot #639444/0776L) respectively. Does of influenza virus vaccine (unspecified) on 03-DEC-2003 (FLUVIRIN) (lot # 765756), 03-DEC-2004 (FLUZONE) (lot # U1515AA), and 19-NOV-2005 (FLUZONE) (lot # U1916AA), First, second, third, and fourth doses of poliovirus vaccine inactivated (unspecified) on 12-OCT-2000 (manufacturer unspecified) (lot # T01872 1/00), 18-DEC-2000 (manufacturer unspecified) (lot # T01872 1/00), 02-JUL-2001 (IPOL) (lot # T0908) and 03-DEC-2004 (IPOL) (lot # X1212) respectively. The patient received a second dose of MMR II (lot # 646126/0781F) on 03-DEC-2004. First, second, third, and fourth doses of Prevnar on 18-DEC-2000 (manufacturer unspecified), 14-FEB-2001 (manufacturer unspecified), 02-JUL-2001 (manufacturer unspecified) (lot # 473349), and 18-APR-2002 (Prevnar) (lot # 484-151). The patient also had tuberculin purified protein derivative on 24-FEB-2003 and 22-FEB-2005. Additional information from the registered nurse indicated that the patient recovered. No further information was available.
Nauseous; I had it in my left arm which that hurt; I had pain that radiated down my arm into my thumb and my index finger; I started getting pain up into my neck; I had pain that radiated down my arm into my thumb and my index finger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset May2021, outcome "unknown", described as "Nauseous"; VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "unknown", described as "I had it in my left arm which that hurt"; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset May2021, outcome "unknown" and all described as "I had pain that radiated down my arm into my thumb and my index finger"; NECK PAIN (non-serious) with onset May2021, outcome "unknown", described as "I started getting pain up into my neck". Therapeutic measures were not taken as a result of nausea, vaccination site pain, pain in extremity, neck pain, pain.  Additional information: NDC and UPC number, Expiry Date of Covid-19 vaccine was unknown, No patient history and investigation assessment reported. Consumer stated, "I just want to ask, I had the Pfizer vaccine (Covid-19 Vaccine) on Monday for the Covid. So and then I had about 11 O'clock in the morning and probably about 7 O'clock at night I just started getting extreme nauseous. I had it in my left arm which that hurt but then I started getting pain up into my neck and I had pain that radiated down my arm into my thumb and my index finger. So, did they may be hit a nerve when they put in the shot." Consumer stated no treatment received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received influenza vaccine around 0930 in the morning and reported immediate pruritis around injection site along with difficulty breathing. Was given oral BENADRYL which decreased symptoms.
Developed shortness of breath 2 weeks after receiving her third COVID-19 vaccine.  Symptoms started at the beginning of December.  Patient was seen by her PCP.  Her D-dimer was elevated.  Chest CT angiogram showed bilateral pulmonary embolism.  No lower extremity DVTs.  Echocardiogram without any ventricular strain.  Patient was admitted in the hospital on 1/6 treated with Lovenox.  Discharged on Xarelto.  Did not require oxygen was not hypoxic.  Platelets were normal.
Induration, erythema, tenderness just below the injection site. Monitoring symptoms, no treatment indicated.
@ 1054 patient reported tingling in left arm, left arm is the arm she had J and J injection in, stated tingling was from lateral pinky finger radiating to elbow area. c/o lightheadedness. denies shortness of breath, headache, fatigue, N/V, no cyanosis noted around lips, injection site without redness or swelling. able to move extremity without pain. v/s checked 98.3, 79, 18, 104/62, spo2 99% on room air. patient stated last meal at 0330, patient accepted 8 ounce bottle of water and had a sandwich with her that she ate. patient education provided for follow up treatment at ER if patient symptoms become worse after leaving site, patient stated understanding. patient continued to sit by this prep nurse for monitoring. 1108 patient stated light headedness has resolved entirely and tingling sensation was diminishing. injection site continues without redness or swelling, denies pain at injection site. continues to deny all other symptoms. 1115 patient stated complete relief of tingling and f/u vital signs 98.3, 86, 18, 112/66, 99% on room air. patient able to raise to standing position without dizziness, patient reeducated on symptoms to monitor for and follow up treatment at ER as needed. stated understanding and released into care of boyfriend.