chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer (patient's mother) refers to a 15 year old male patient. The patient had no pertinent medical history but was allergic to dairy, pistachios and penicillin. On 20-SEP-2016 the patient was vaccinated with the first dose of GARDASIL or GARDASIL 9 (unspecified Merck HPV vaccine, lot number provided) via the intramuscular route. On the same day, patient was also administered and unspecified flu shot (also reported as concomitant medication). The patient had a full physical that day. He was fine in the office and went home. He ate 'takeout food'  for dinner and went to bed. When he awoke on 21-SEP-2016, he told his mother that he felt dizzy and his stomach felt horrible (abdominal discomfort). The patient threw up and then went to bed to rest. He woke up again sometime later but he was still feeling sick and dizzy. Patient received treatment for the events. No laboratory tests were performed. Patient had not recovered from the events. Patient received treatment for the events. No laboratory tests were performed. Patient had not recovered from the events. Causality assessment was not provided. Additional information is not expected since the physician cannot be contacted.
patient received 2 flu vaccines Flublok and Fluzone Quadrivalent, It was intended that the patient receive Gardasil with an influenza vaccine/ No AE; Patient received 2 flu vaccines Flublok and Fluzone Quadrivalent, It was intended that the patient receive Gardasil with an influenza vaccine. They were picked back up, a Flublok syringe was picked up in place of the Gardasil syringe/ No AE; 11 year old patient received 2 flu vaccines Flublok and Fluzone Quadrivalent, It was intended that the patient receive Gardasil with an influenza vaccine/ No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff).  This case involves a 11 years old female patient who received vaccines INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1903, expiry May-2020 via unknown route in the right arm and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ223AA via unknown route in the left arm On 23-Sep-2019. The patient received FLUBLOK QIV instead of HPV VACCINE VLP RL1 4V (YEAST) [GARDASIL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines received. Notes: The patient does not have an egg allergy   It was a case of actual medication error due to Extra dose administered, Inappropriate age at vaccine administration and wrong vaccine administered. It was intended for the patient to receive influenza vaccine and Gardasil. Two medical assistants were working with the same physician. The Medical Assistant laid the shots down after they were prepared, and then when they were picked back up, a Flublok prefilled syringe was picked up in place of the Gardasil prefilled syringe. The caller stated that the patient "weighs a lot" and she was hoping that the weight of the patient might mitigate any adverse effect of receiving a double dose of influenza vaccine  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
This spontaneous report as received from a physician via company representative, refers to a 17 year old female patient. On 17-SEP-2013 was vaccinated with the dose of VARIVAX (dose, route of administration and lot number were not reported). In September 2013 the patient developed chicken pox after receiving VARIVAX. The patient sought medical attention via a physician visit. The patient was not treated for the event. The outcome of chicken pox was reported as not recovered/not resolved. The relatedness between the event and VARIVAX was not reported. Additional information has been requested.
Patient came in complaining of warmth, tenderness, and redness distally away from the injection site up to elbow area. Pt identified as injection site at upper deltoid however no reactions (ie warmth, tenderness or redness) near the patient reported injection store.  Advised to follow up with MD for consult.
fatigue; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, between 2 and 4 months after receiving Shingrix, the patient experienced fatigue and injection site pain. On an unknown date, the outcome of the fatigue and injection site pain were unknown.   It was unknown if the reporter considered the fatigue and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported.  The patient received 1st dose of Shingrx was around late August-early September 2019. After that she felt some fatigue and soreness at the injection site.  This case has been linked with case US2020029074 and US2020AMR029706, reported by same reporter.
Headache, swelling in arm Narrative: Reported a headache and swelling of arm that received injection. Took acetaminophen (dose unknown) and used warm compress to relieve symptoms.
Sharp, stabbing, throbbing pain radiating down right arm, pain when lifting, pushing, pulling, turning, difficulty sleeping and doing everyday chores.  The pain continues to this day.
Parent filled out consent, vaccine was pulled and verified. Patient received 5+ primary dose, patient is 4 years old.  When documenting NDC did not match with order placed by provider.
Headache; Muscle aches (predominantly in chest and leg); Sensitivity to noise; light sensity; pain in leg; Muscle aches (predominantly in chest and leg); This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced headache, myalgia of lower extremities, hyperacusis, photophobia, leg pain and musculoskeletal chest pain. On an unknown date, the outcome of the headache and musculoskeletal chest pain were recovering/resolving and the outcome of the myalgia of lower extremities was unknown and the outcome of the hyperacusis, photophobia and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, myalgia of lower extremities, hyperacusis, photophobia, leg pain and musculoskeletal chest pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix intramuscularly on left deltoid and experienced headache, muscle aches (predominately in the chest and legs), sensitivity to light, and sensitivity to noise.  The muscle aches made the patient feel like she could not move.   These symptoms started out mild in the evening prior to when she went to bed and worsened overnight.   The symptoms were less the morning at the time of reporting, although the reporter was trying to decide if he should take her to the emergency room.   The chest pain was less and the headache was a little better.  The patients legs were really sore.   The light and noise sensitivity was unchanged. The reporter did not consent to follow-up.
fatigue, body aches, congestion, shortness of breath- appear to be typical response. Refill inhaler at this visit and follow up as needed
Patient's relative reported patient had stroke 2 days after COVID-19 shot. Patient's relative then reported patient had long-lasting nerve pain and numbness in extremities that are currently experienced on a daily basis.
Morbiliform rash and fever and febrile seizure on 8/29/15 seen at ER.
headache/hard headache; weak legs; arm was numb; feels off-balance/she feels like she is not walking straight, she feels like it goes to one side, she's unbalanced; the whole arm, the left arm where they put the vaccination yesterday feels kind of numb; she is limping; she went to work feeling fine but she started to not feel good; arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 15:15 (Lot number: EW0217) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: diagnosed probably 10 years ago. she controls it with medication but nothing else besides that. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jun2021, outcome "not recovered", described as "arm pain"; HEADACHE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "headache/hard headache"; MUSCULAR WEAKNESS (non-serious) with onset 09Jun2021, outcome "not recovered", described as "weak legs"; HYPOAESTHESIA (non-serious) with onset 09Jun2021, outcome "not recovered", described as "arm was numb"; BALANCE DISORDER (non-serious) with onset 09Jun2021, outcome "not recovered", described as "feels off-balance/she feels like she is not walking straight, she feels like it goes to one side, she's unbalanced"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 09Jun2021, outcome "not recovered", described as "the whole arm, the left arm where they put the vaccination yesterday feels kind of numb"; GAIT DISTURBANCE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "she is limping"; MALAISE (non-serious) with onset 09Jun2021, outcome "not recovered", described as "she went to work feeling fine but she started to not feel good ".  Additional information: Caller is calling for his wife (61-yr old female) who had the first dose of the Pfizer COVID-19 vaccine yesterday (08Jun2021). She had arm pain. Today (09Jun2021), she went to work feeling fine but she started to not feel good. She has headache, weak legs, her arm was numb (same arm with the injection site), feels off-balance (can't walk straight, leans on right side). Caller wanted to know if these adverse events are normal or had been reported. He also wanted to know how long they should wait before seeing a doctor.  Caller's wife has talked with her HCP and she was advised to take a rest. No follow-up attempts are possible. No further information is expected.
Sore throat started 2 hours after receiving flu vaccination. Complaints of lethargy, stuffy nose, fatigue remaining. Slight bump at injection site was gone by 10/20/16 AM.
Dizziness, BP 141/89 (pulse 82). Gave juice, water.
Shortness of breath, lightheadedness, chills, later tingling of fingers, hands, arms, and tingling on legs from knees down. Patient went to ER, vital signs normal. Patient given CLARITIN tablet at 5:30pm.
Left upper arm with redness and swelling around site of injection for 24-36 hours after injection. Fine follicular rash over entire body and face starting 3 days after, injection and lasting 2 days.
Information has been received from the published literature article referring to an 11 year old male patient with asthma and allergy to fluconazole and penicillins. On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (manufacturer unknown), a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and a dose of meningococcal conj vaccine (unspecified) (dose, route and lot# were unknown).  Immediately after vaccination, the patient experienced generalized urticaria, pruritus and rash, angioedema and swelling (tonsils). The initial evaluation was performed in a clinic and a family practice provider provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with epinephrine and parenteral steroid. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012691, 1606USA012693). Additional information has been requested.
Patient was to receive Hepatitis A vaccine at patient's wellness visit; however, patient received Hepatitis B instead.  Hepatitis A vaccine will be administered at next wellness visit.
When I got the shot to begin with I always get some soreness at injection site, this one was the size of an apple, it was hot to touch, it itched all the way down my arm. I was down for 2 days with fever chills, heart palpitations, joint pain and muscle pain. Then 7 months later I started getting really mild period like cramping and then I started my period. I had one full cycle 7 days then it stopped and never happened again. I had not had a cycle in 5 years.
Pain in the site and Down My left arm. My Arm still hurt. I cannot Lay My left arm on side.
Administered the Moderna COVID vaccine to a 13 year old patient where the vaccine is approved for 18 and older.
fever >102, chills, aches, headache, nausea, insomnia.  Started 6 hours after vaccine administration and last about 18 hours
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 30-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.                   No treatment medication was reported.
Injection site pain, headache, muscle aches, "cottony" taste, congestion, slightly runny first thing in am
No ADE. Patient was under the age of approval for Pfizer. Parent purposefully gave wrong DOB year to allow vaccination when not indicated or approved.  2nd dose not administered at our pharmacy but discovered upon returning for booster at our location and asking for a new card due to incorrect DOB (but we have parent's form they filled out with DOB clearly wrong and signature)
The patient confirmed 2nd dose of Moderna was given on 2/5/21, is allergic to shrimp, and has Asthma. 3rd dose of Moderna was administered today at 9:15 am.  The patient was monitored for 30 mins. 9;29 am, the patient-reported symptoms of light-headed, stomach cramp, face and back feeling hot and itchy, and lastly had diarrhea and fatigue. The patient also stated that she did not have anything to eat prior to taking the vaccine. Upon assessment, the patient is A&O.  V/S was taken at 9:40 am BP 142/65, HR 61, O2SAT 100. The patient was asked to stay for an additional hour for observation and when she was stable she was picked up by her friend.
Pt returned to office on 9/24/03 to have arm rechecked. Mom reports that arm has developed skin-muscle deformity at site of injection, within 2 weeks of injection. Right arm has developed a mild lipodystrophy at site of subcutaneous Varivax administration.
Information has been received from a licensed visiting nurse concerning a 7 year old male who on 17-JUL-2007 at 14:15 PM was vaccinated SC on right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657109/0444U). It was reported that on 19-JUL-2007, the patient developed injection site reactions involving redness, swelling and induration. Additional information has been received from the licensed visiting nurse who stated patient had injection site pain and swelling on 19-JUL-2007. Additional information has been received from licensed visiting nurse who stated the patient experienced redness and swelling at injection site and had some pain. At the time of report the patient had recovered. No further information is expected. This is one of several reports from the same source.
Im having a lot tingling in finger on the side the in got in injection and  back side pain
Pain in the right arm at all times, decreased range of motion. Can't sleep on the right side.
RECVD ENGERIX-B INJECT ALONG WITH HBIG ON 3-13-90 FOR NEEDLE STICK INJURY. ONE DAY LATER PT HAD ONSET OF NAUSEA, VOMITING, DIARRHEA. NO TREATMENT GIVEN. AS OF 3-19-90,PT DID NOT FEEL WELL
Swollen and tender armpit; Swollen and tender armpit; Moving back pain: middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again. Each day is different location; Moving back pain: middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again. Each day is different location; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO175) via an unspecified route of administration on 03May2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 as a single dose for COVID-19 immunisation and received ciprofloxacin (CIPRO) and amoxicillin (MANUFACTURER UNKNOWN); both for unknown indication on unknown date and experienced drug allergy. On 03May2021, post second dose, the patient experienced swollen and tender armpit for first 7 days, each day decreasing and moving back pain, first in the middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again. Each day back pain was in different location. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen and tender armpit for first 7 days, each day decreasing was resolved on 10May2021 and of the events moving back pain, first in the middle of the back, then lower, then upper, then back down to lower, starting with dull pain, then more of a burning sensation, now back to middle of the back, dull pain again was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
He developed a pruritic rash on bilateral upper extremities and trunk with no improvement with benadryl.
pt passed out after receiving 2nd covid vaccine.  had convulsions, urinated on floor. had to use ammonia to revive pt.. then shortly after pt started convulsing again . paramedics where called and pt left pharmacy on stretcher
Incorrect dose administered after recent CDC changes discontinue monovalent.  Dose administered 0.2mg bivalent Pink/Yellow. Should have received 0.25ml/25ug  Dark Blue cap/gray border.
Pregnancy/Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy/Exposure during pregnancy) in a 37-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Jun-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy/Exposure during pregnancy). The delivery occurred on an unknown date. For neonate 1, estimated due date: 20-Jun-2021 there has been no  complications or acute illnesses during this pregnancy to date. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy/Exposure during pregnancy) outcome was unknown.            Caller would like to register for pregnancy registry - was talking to someone but got disconnected No details below of prenatal testing/investigations during pregnancy to date (ultrasounds, amniocentesis, glucose tolerance, etc.) were provided, also the details concerning the patient's chronic or long-standing health conditions (diabetes, seizure disorder, hypertension, mental health disorders, asthma, etc.) were not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: initially the patient called on 19-Mar-2021 but the call got disconnected thereby the follow up was generated the patient reported her details on 26-Mar-2021