chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 12 month old white female with congenital hypothyroidism who on 26Mar04 (also reported as 23Mar04) was vaccinated SC in the left thigh (also reported as left leg) with a first dose of varicella virus vaccine live (lot 647267/1099N). There was no illness at the time of vaccination. Concomitant therapies that day included a second dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (lot 0917N) administered IM in the right thigh and a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 646125/0678N) admin IM in the right thigh. On 04Apr04, the pt was taken to the ER with nausea and vomiting. She was treated with IV fluids, and the nausea and vomiting resolved. On 06Apr04, the pt was again taken to the ER with vomiting, dehydration, a temp of 96.8 F, and a rash on her trunk, neck and diaper area. At that time the child was diagnosed with chickenpox. The child was treated and released. Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as recovered. Follow up information received from a registered nurse indicated that on 06Apr04 at 9:50AM, the pt was brought to the ER for dehydration and fever, had chickenpox rash on neck, trunk and diaper area (also reported as has bumps everywhere- neck, trunk, diaper area). It was noted that the child was seen 2 days ago (also reported as 04apr04) in the ER for hypervolemia and received IV fluids. No further information has been requested.
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A female patient of an unspecified age received the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of TRUMENBA on an unspecified date. It was reported that back in Jul2018, the patient experienced malaise, feverish and fatigue after meningococcal group b rlp2086 was received on an unspecified date in 2018. This was the second dose and the nurse was unsure if anything happened with the first dose but they did complete the 2 dose series. Outcome of the events was unknown.
Patient received the Janssen COVID vaccine ( lot #201A21A) at approximately 1850. At 1852, patient complained of feeling lightheaded, Paramedic walked the patient to the zero-gravity chair and placed the patient supine. Vital signs: blood pressure 104/72, O2 97%, pulse 56, respirations 16. PHN approached to assess the patient, noting no work of breathing. Patient denied shortness of breath, nausea or feeling sweaty. Patient was given water and started to drink it. Patient reported no allergies, taking medications, nor medical conditions. PHN offered patient Benadryl but patient refused. At 1853, patient reported symptoms had resolved. PHN encouraged patient to remain for 30min monitoring, to follow up with provider, and when to call 911. At 1903, patient continued to report no symptoms. VItal signs: blood pressure 108/76, pulse 64, respirations 16. Patient reported her blood pressure usually runs low around 110/70. At 1904, patient stood up, monitored closely by PHN and Paramedic. Patient continued to report no feelings of lightheadedness. Patient reported she wanted to leave despite recommended 30min monitoring after reporting symptoms. At 1905, patient left walking with steady gait.
This spontaneous report was received from a consumer regarding her 6 month old male son. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 25-APR-2017 (reported as "yesterday"), the patient was vaccinated with a dose of ROTATEQ oral liquid (dose, lot number and expiration were not reported) administered orally for prophylaxis. According to the reporter, the patient spat at least half of it out. It was reported that the patient had previously received ROTATEQ and swallowed it without any issues. The outcome of the event infantile spitting up was not reported. The reporter did not provide a causality assessment between infantile spitting up and the suspect vaccine. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA001581:
A non-serious spontaneous report of FLUMIST administered to pregnant woman was received from a health professional concerning an adult female. Neither relevant medical history nor obstetrical history have been reported for this patient. No concomitant medications have been reported for this patient. On 02-Nov-2011, the patient received FLUMIST as she was unaware of the pregnancy. There was not adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable and the event is considered resolved. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
a pregnant patient was administered Fluzone, with no reported adverse event; Initial information received on 15-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non-health professional.  This case involves a 28 years old female pregnant patient who was vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [exposure during pregnancy].   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 31 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] at 31 weeks of pregnancy, during third pregnancy trimester for the vaccine.  The date of last menstrual period was reported as 14-Feb-2021.  The estimated due date was 08-Nov-2021.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 15-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7325QA; expiry date: 30-Jun-2021; Form: suspension for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.  At time of reporting, the outcome was unknown for the reported event.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.
fully vaccinated (moderna, 2/24/21, 3/24/21), symptom onset 8/7/21
Severe pain, redness and swelling to L upper arm; also noted itching. Pt was given Vicodin, Prednisone and Benadryl; ice to the area.
I had a dry cough, backache, fever and general weakness. The highest temperature was 100.7 which started on February 07, 2023.  I contacted my doctor after having the symptoms for 3 days. I was taking Tylenol and Robitussin DM. I also started using my Albuterol inhaler which I would use as needed. My doctor prescribed Paxlovid as well. The fever was gone on February 08, 2023, and the coughing was minor and subsided on February 10, 2023. By February 09, 2023, I no longer had the aches. The weakness lasted for several more days. My test was positive through February 20 but at that point I stopped testing.
5mins p/vax pt fell over on the table becoming pale & less alert, began to tremor-whole body lasting 30-45sec p/vax;devel hive on arms & abd & back
After receiving Pfizer 0.3ml IM in left deltoid, patient states could feel it traveling down her arm to her hand. Patient has raised spongy spot about the size of a quarter that appeared within minutes. B/P was 130/76 at 10:56. After waiting 15 minutes patient complains of headache and sore left wrist when bending. Patient B/P is 128/70. Patient waited an additional 15 minutes with no change in status. Plans to confer with HCP this afternoon regarding the above.
The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it.
Right leg problem started in afternoon of Friday (pm) 8/10/07 c/o pain with weight bearing. crying, no fever. Mono arthralgia - etiology unknown.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
Initial and follow-up information has been received from the Merck Pregnancy Registry via a licensed practical nurse concerning a 14 year old female with no pertinent medical history who on 20-SEP-2007 was vaccinated intramuscularly with a first dose of Gardasil (lot #657617/0384U). There was no concomitant medication. On 25-SEP-2007, the patient was found to be pregnant with a positive Pregnancy test at the office. Follow-up information received from the licensed practical nurse reported that the patient had an abortion at approximately 5 weeks gestation. The licensed practical nurse reported that the abortion was for reasons other than therapy with Gardasil, including that the patient was only 14 years old. Upon internal review, abortion was considered to be an other important medical event. Additional information is not expected.
No additional adverse event reported; M-M-R II with expiration date of 12-JAN-2022 was administered to a patient; This spontaneous report was received from a nurse practitioner concerning to a 13-month-child female patient. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 13-JAN-2021, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # T001213, expiry date 12-JAN-2022 (dose, anatomical location, route of administration was not reported) for prophylaxis (expired product administered). No other adverse event reported.
PATIENT HAD SORENESS THE SAME DAY OF VACCINATION (10/7/19), THREE DAYS LATER THE PATIENT WOKE UP AT 0600 WITH A RASH EXTENDING DOWN HIS LEFT UPPER ARM FROM INJECTION SITE. THE RASH WAS RED AND WARM TO TOUCH. PATIENT COMPLAINED OF PAIN AT SITE OF RASH
No additional AE details were provided and no additional AE's were reported.; An HCP is reporting an AE on behalf of a patient. The HCP reports that a patient was administered a dose of ROTATEQ after it was involved in a temperature excursion.; This spontaneous report was received from a certified medical assistant referring to a patient (age and gender not provided). No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications.  06-JAN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml oral, lot #1837126, expiration date: 14-OCT-2023, administered for prophylaxis (strength and anatomical location were not provided) following temperature excursion (date not reported), at a temperature of 10.3 C degrees for an unknown period, it was noted that there was no other temperature excursion.  No additional adverse effects were reported to the patient.
fatigued and tired, sore arm within a day.  On day 8-9 very large red area and swelling from below injection site to elbow, itching and very uncomfortable.
Patient had this vaccine administered on 1/3/22 and 1/28/22 after its "use-by date" of 1/1/22. 1/1/22 is the 31 days of refrigeration. Expiration date is February 2022. No adverse reactions reported.
loss of consciousness (not witnessed, unknown duration), "grogginess", amnesia of event, dizziness and nausea upon awakening, husband had to shake her and call her name to arouse her. This occurred within 24 hours of the immunizations. Presented to the ER 3 hours later.
Tetanus shot administered 6-12-17, hospitalized 6-13-17 dysentery, vomiting, fever 103 degrees, tightness in chest and high BP 246/90 experienced w-loss of 6 lbs. in 2 days, then experienced pneumonia symptoms and given a penicillin shot 6-12-17 at urgent care->6-13-17 then went to hospital, diagnosed w-acute URI, discharged 6-13-17 at 22:18. Somewhat better w-low fever and pneumonia and pain in chest.
Red welt at injection site; Pain at injection site/Tenderness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Red welt at injection site), VACCINATION SITE PAIN (Pain at injection site/Tenderness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no specified medical history was reported.  Concomitant products included LISINOPRIL and PRAVASTATIN for an unknown indication.    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 VACCINATION SITE SWELLING (Red welt at injection site), VACCINATION SITE PAIN (Pain at injection site/Tenderness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Red welt at injection site), VACCINATION SITE PAIN (Pain at injection site/Tenderness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
i do suffer from androgenic alopecia since i was diagnosed at 24, but hair loss has been gradual on the scalp over the decades. i had started PRP treatments several years ago, with good results and my hair filling in up top. i had fuller hair on the sides though over all, when i was younger before this, i had 3x as much hair.  then, after my first two covid shots, in july my hair started coming out at alarming speed.  i was losing not only on the scalp, but all over, which is not the pattern for AGA.  in october, it was still happening, and my hair is so thin now that it is see through.  it is devastating.  i got my booster in mid november and my hair loss increased again.  i totally associate everything with the timing of my covid vaccines and booster.
This spontaneous report received from a physician concerned a 55 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No prior history of either ITP, symmetric polyarthritis, RH positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the healthy patient developed Immune thrombocytopenic purpura after vaccination. On an unspecified date, the patient developed a symmetric polyarthritis with positive rheumatoid factor. The outcome of the immune thrombocytopenic purpura and symmetric polyarthritis with rheumatoid factor positive was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211028796- covid-19 vaccine ad26.cov2.s - immune thrombocytopenic purpura and symmetric polyarthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Child began to lose consciousness as he was leaving clinic. Mother assisted to floor feet were elevated and he was given juice and candy when he was able to swallow. Observed 20 minutes, left ambulatory.
Initial and follow up information has been received from a licensed practical nurse (LPN) concerning a 17 year old female student with long standing not controlled asthma, perennial allergic rhinoconjunctivitis, and acute sinusitis who on 04-JAN-2008 at 3:00 p.m. was vaccinated IM in left deltoid with her first dose of Gardasil, lot# 659439/1267U. Concomitant therapy included beclomethasone dipropionate (QVAR). On 04-JAN-2008 at 8:00 p.m. the patient experienced tingling of the lips and facial flushing. The patient was prescribed diphenhydramine hcl (BENADRYL). On 05-JAN-2008, the patient recovered. The reporter felt that the events were other important medical events. Additional information is not expected.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information were provided.  Patient did not report any adverse event. The vial did not undergo any temperature excursion. The vaccine was placed in the refrigerator on 18-Oct-2021.   This case was linked to MOD-2022-491837 (Patient Link).
No additional AE information provided.; patient was administered a dose of Prevnar 13 on 2/11/2020 and was administered a dose of PNEUMOV AX 23 on 3/13/2020.; This spontaneous report was received from a registered nurse and refers to a 41-year-old female patient. The patient's concurrent conditions included lupus, rheumatoid arthritis (RA), hypertension, deep vein thrombosis (DVT), and gastrooesophageal reflux disease (GERD). The patient's medical history, concomitant medications, and drug reactions or allergies were not reported.  On 11-FEB-2020, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, frequency, route of administration, lot number, and expiration date were not provided) for an indication not provided.  On 13-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular injection (dose, frequency, lot number, and expiration date not reported), as "preventative" since the patient was at "high risk" because of her concurrent conditions (inappropriate schedule of product administration). No additional adverse event information was provided.
This case was reported by a healthcare professional (nurse) and described the occurrence of leg tenderness in a 48-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 5 November 2012 at 10:33 the subject received 1st dose of BOOSTRIX (.5 ml, intramuscular, left arm). On 9 November 2012, 4 days after vaccination with BOOSTRIX, the subject experienced leg tenderness, muscular contracture leg ("contracting muscles in her legs"), weakness of hand and arm, tightness of muscles ("tightness in hands and arms") and activities of daily living impaired. The healthcare professional considered the events were life threatening. The reporter stated that the events were life threatening "because it's affecting the patient's daily life." At the time of reporting the events were unresolved.
At 1:10 PM administered vaccine 1:20PM - 1:50PM patient experienced dizziness blood pressure increased to 203/107. At 1:50PM paramedics called to take patient for observation.
Received Flu shot at 8:15 am. At about 9:30 - 9:45 I was summoned to the staff break room. Staff person was weak, sleepy, unable to stay fully awake during conversation. He was reporting feeling "dizzy", had difficulty sitting up straight. EMS was called at this time.
Information has been received from a consumer referring to an unknown number of 30 to 40 year old patients of unknown gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with ZOSTAVAX (dosage, strength and lot # unknown) (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
Approximately 9 days after vaccination a 1 cm tender indurated lump in left upper lateral thigh appeared. Had physician appointment on 07-05-17. Dx - cellulitis lower extremity. Rx-cephalexin.
Red rash, hypertension, tachycardia.  Symptoms resolved and patient was returned to work the next day.  She did have some mild itching for a couple days following the vaccine.
5 x10 cm area surrounding injection site of swelling, itching & redness around perimeter. No fever or systemic reactions. No treatment given. Advised pt may take BENADRYL. She has been using hydrocortisone cream at home.
Four hours after my second dose, I started to grow light-headed. I got up from my desk and stumbled over as I couldn't see quite straight. The rest of the evening I rested and stayed hydrated with fluids. From Thursday morning until Saturday morning I was unable to focus, concentrate, see straight, and got "foggy" every time I tried to stand and walk. I had a hard time keeping my eyes open and was very weak. It felt like I was under the influence of something as I felt extremely disoriented. It has been 9 days since my second dose and I am still not "100%" back to my normal self. These side effects were very scary to deal with.
The patient received a 2nd booster dose. Patient did not recall having a prior booster, but the database reports that the patient had one on 11/9/21.