chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received the Pfizer bivalent booster vaccine but had never received any doses of a primary series. No adverse events were reported.
Nurse administered TDaP which is for ages over 7 years old instead of DTaP which is for her age range.  Nurse stated that father was adament about patient getting the TDaP vaccine so she went ahead and gave the immunization he requested.
Patient came into a community vaccine clinic for his Moderna COVID 19 booster dose. Dose administered should have been 0.25ml and 0.5ml was administered to patient.  After administration it was found out that Moderna vial was expired.
felt discomfort at the injection site; felt like she had to support her arm to lift it and it was painful; have some soreness; felt like she had to support her arm to lift it and it was painful; This is a spontaneous report from a contactable pharmacist (the patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number was not provided), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided.  Patient reported she has experienced this with Flu vaccine (FLU ARIX) (GlaxoSmithKline). Patient does not have an NDC, Lot or expiration date, reporter stated she had the vaccine in September 2020 or the first of October 2020. On an unspecified date, the patient felt discomfort at the injection site, she felt like she had to support her arm to lift it and it was painful. Patient stated that vaccine is mandatory and she generally does have some soreness. Investigation assessment was not Provided. Patient stated that her Pfizer NDC number was the same as for the previous reports filed. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
8/19/04 phone call. Has been over 36 hr since injection with no relief from Tylenol, cool compress, etc. Referred to physician. Got kindergarten shots Tues in HD. Got DTaP in right arm-now very red, hot, sore and swollen. Ear right, mom cleaning with Q-tip, started to bleed.  Pt alert with NAD, minimal abrasion Left ear. Lungs okay. Eating. 16cmx8cm area of erythema and tenderness, warmth to right upper arm, swelling injection site. Some reaction US 2 hr after injection. Continue Benadryl as directed, add Augmentin 600 ES. 1 1/2 tsp every BID for 10 days. To CB with concerns or not better with treatment.
Pt experience, pain, fever and swelling of the entire arm and hand. Pt has difficulty moving her hand.
recvd phone call from pt's grandma stating that pt devel hives p/HBV inject; no fever or other sx but hives on entire body; presently taking DPh;
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with Engerix B (manufacturer unknown) for prophylaxis.  On an unspecified date the subject received unspecified dose of Engerix B (20 mcg, unknown).  At an unspecified time after vaccination with Engerix B, the subject was tested and had no antibodies.  A registered nurse reported that her office provided the subject with a prescription to receive the adult series of vaccine for Engerix B; however, the subject received the Engerix B vaccine series at another unspecified location.  Thus, the reporting nurse does not know the manufacturer of the vaccine as the prescription was filled at a pharmacy.  The nurse considered the event was probably related to vaccination with Engerix B.  At the time of reporting the outcome of the event was unspecified.
I received my first shot (COVID) 9 Mar 2021.  One week later I started developing lighter patches of skin on my forehead and around the outer edges of both eyes.  I have been diagnose with very mild case of vitiligo (1%) on my face about 4-5 years ago but it went into remission.  Now it has seem to resurface after my first shot but only around the areas as I described which I have never had these areas effected by vitiligo. My question should I get the second and final round of the vaccine?
3 hrs after immunization pt complained of tightness in chest & throat swelling. Went to ER. Received prednisone.
4 DAYS OF FEVER TO 101 DEGREES AND RASH ON ABDOMEN, TRUNK, LEGS AND GENITAL AREA.  RASH CONSISTS OF PUSTULES WITH ERYTHEMATOUS BASES.  NO CROPS, NO VESICLES.
Patient called the day after receiving the shot and told me about a reaction that she had. She stated that she had no issues after getting the shot on 7/1/19 until just before she was going to bed. Then she developed shivers, which lasted a couple hours . Then she said the following morning on 7/2/19 when she awoke she fainted and needed assistance from the facility that she lives in. Upon calling the pharmacy on 7/2 she stated she was starting to feel better but wanted to report the incident as it wasn't expected. She was offered to go to the hospital from the facility, but she declined and was able to stay home.
arm got sore; Worsening cough; Worsening Chest Congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Worsening cough), NASAL CONGESTION (Worsening Chest Congestion) and PAIN IN EXTREMITY (arm got sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Congestion nasal (Prior to both doses, patient had chest congestion.). Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COUGH (Worsening cough) and NASAL CONGESTION (Worsening Chest Congestion). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm got sore). At the time of the report, COUGH (Worsening cough), NASAL CONGESTION (Worsening Chest Congestion) and PAIN IN EXTREMITY (arm got sore) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) heart rate was kind of fast.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included steroids for wheezing and shortness of breath. No treatment information was provided.   This case was linked to MOD-2021-089446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26-May-2021 and updated reporter information, laboratory information,concomitant medication, new events
feels like an old lady; can't stand; having trouble sleeping; hand hurts; Muscles ache, body ache; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts) and MYALGIA (Muscles ache, body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts), MYALGIA (Muscles ache, body ache) and PYREXIA (High Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (feels like an old lady), DYSSTASIA (can't stand), INSOMNIA (having trouble sleeping), PAIN IN EXTREMITY (hand hurts), MYALGIA (Muscles ache, body ache) and PYREXIA (High Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: reporter contact details updated (email ID).
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. Since 06-JAN-2016, an unknown number of unspecified patients have been administered doses of RECOMBIVAX HB lot # L027733, exp. 13-SEP-2017, lot # L016959, exp. 12-MAR-2018 and lot # L045117, exp. 06-OCT-2018 (dose, route and site of administration were not reported) that have been improperly stored. The temperature of the storage was 33 Fahrenheit degree for 3.5 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Exactly  1 month 03/02/2021 varicella/ herpes outbreak  by left eye!
blood pressure has been elevated; started to feel lymph nodes; swollen lymph nodes; fatigue; pain; A spontaneous authority report was received from a  consumer concerning an  42-year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and  experienced Pain, Blood pressure elevated, fatigue, started to feel lymph node on her left armpit, started to feel the one in the collarbone and neck, lymph nodes multiply in collarbone.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications were not reported.  On 05 Jan  2021, the patient received their  first  of two planned doses of mRNA-1273 (lot number  025J20-2A) intramuscularly in the  left arm for prophylaxis of COVID-19 infection.  On 05 Jan 2021, after vaccination the patient felt pain, fatigue. On 9-Jan 2021 she started to feel lymph nodes on her armpit, lymph node multiply in collarbone.  Treatment information  provided was Ibuprofen for 3 days.  Action taken with mRNA-1273 in response to the events was not reported.  started to feel lymph node on her left armpit, started to feel the one in the collarbone and neck, lymph nodes multiply in collarbone Blood pressure elevated were unknown.   The outcome of the events  pain, fatigue were  Resolved.
Patient got the vaccine around 12:45pm. At around 1 pm, the patient fainted for about 7 seconds and fell out of the chair in the waiting room. I ran outside of the pharmacy to assist him. He was conscious but confused for a few moments. Then said he felt fine. Patient showed no signs of allergic reaction. I asked him if he had any injuries/bleeding and he said no. I asked him to stay at the pharmacy for another 30 minutes so I could observe him closely. We gave him a cup of cool water to sip on. At around 1:10 pm, I went outside the pharmacy to check on him again and he said he felt flushed and asked for a bucket.  At 1:15 pm, he vomited into the bucket. He said he felt 100% better after vomiting. I had him stay at pharmacy until shortly after 1:30 pm when he said he felt okay to go home. I called him at home around pm the same day and he said he felt fine.
Accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm; Accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EI.9267), via an unspecified route of administration, administered in Arm Left on 09Feb2021 13:30 as single dose for COVID-19 immunisation. The patient was taking COVID Vaccine Right thing to do and also high risk because has Type II Diabetes. Medical history included ongoing Diabetes Type II, Blood pressure high, dry eye, Neuropathy, patient was allergic to a number of medications and allergic to certain things (but not sure if those are considered a vaccine), allergic to Penicillin and Tetracycline and eye stroke (Doctor told to take because has dry eye and was informed could get something referred to as eye stroke). Concomitant medications included BAYER ASPIRIN, 81 ng, daily for Blood pressure, Gabapentin 400 mg, five a day for neuropathy, Glipizide 5 mg, two pills two times daily for Diabetes, Lisinopril 20/25 mg once a day for Blood pressure high, and Systane ultra twice daily for dry eye and eye stroke. The patient previously took tetracycline and experienced drug hypersensitivity. It was reported that patient was not prior vaccinated within 4 weeks. On 02Mar2021, the patient experienced accident with left arm/banging his arm into the chair and it ripped the skin on the top layer of his arm which was considered serious as medically significant event and for which patient visited to local emergency room but not physicians office and the HCP gave him a tetanus shot. The doctor there said he would not have any problems with getting the second shot. It was reported that patient was supposed to get his 2nd dose on 02Mar2021 but due to the storms) they were not able to get the vaccines in on time and his appointment was changed to next Tuesday. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Initial and follow-up information has been received for the pregnancy registry for GARDASIL from a nurse, a physician and a 29 year old female with a history of anemia, asthma and seasonal allergies, who on 10-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 0573X) 0.5 mL, IM into her deltoid, when she was six and a half months pregnant. Concomitant medication included REPLIVA and FLONASE. The nurse and the physician reported that the patient has an estimated delivery date of 01-DEC-2008. The patient's condition was not determined to be life threatening, or resulting in significant disability/incapacity, not related to a congenital anomaly, not related to an overdose, not related to cancer, and there was no need for intervention to prevent serious criteria. The patient sought unspecified medical attention. On an unspecified date, there was a pregnancy test performed resulting positive. On 14-JUL-2008, a routine ultrasound test was performed resulting in a normal survey. Follow-up information was received from a physician who reported that the patient delivered a normal baby on 26-NOV-2008. The baby was male and weighed 9 pounds 5.9 ounces, and the APGAR score was 9/9. The infant was born with a congenital small ear tag in his left ear. There were no other complications or abnormalities. The physician reported that during the pregnancy the patient had a normal level II ultrasound/fetal survey at 20 weeks. The patient had no complications during the pregnancy and labor/delivery. There were no infections or illnesses during pregnancy. The patient's medications used during this pregnancy included REPLIVA 1 tablet daily since 11-SEP-2008 for anaemia, and FLONASE daily since preconception. Additional information has been requested.
Soreness in the arm; tenderness; rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the arm), TENDERNESS (tenderness) and RASH (rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the arm), TENDERNESS (tenderness) and RASH (rash). At the time of the report, PAIN IN EXTREMITY (Soreness in the arm), TENDERNESS (tenderness) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Reporter information updated.
Extreme muscle pain and cramping in legs, followed by chills and cold sweats and high fever over 104, after about 4 hours this turned into involuntary convulsions all through the night. In the morning head was severely painful, unlike a migraine but felt like brain was swelling, still experiencing the chills and body aches and sweats off and on . Very dizzy and nauseous from the head ache. Ibuprofen and acetaminophen taken and did not help. I am extremely sick from this second dose.
Received dose 2 on 1/27/2021, when I was 4w0d pregnant. Estimated date of delivery 10/06/2021. Ultrasound at 12w1d revealed increased fetal nuchal translucency of 4.56mm. Further testing revealed a de novo 16p11.2 chromosomal duplication. Ultrasound at 16w1d revealed cystic hygroma measuring 8mm with nuchal cyst/septation, and unilateral right club foot. The pregnancy was terminated for medical reasons on 4/30/2021 at 17w1d.
Client became nauseous,felt like throat was swelling,dyspneic,palpitatipns,thirsty,confused as to location. Oxygen started at 4liters, epinephrine 0.3mg given right lateral thigh at 1139. Placed on mat in supine position with legs elevated. BP 166/95,HR 112,R22 at 1138.  Client was able to speak without difficulty,reports feeling as if is running,leg tremors noted. Pulse ox range from 95 to99%. 911 called at 1136,arrived at 1150. Client reported feeling A little better at 1145, VS 140/82,p 111,resp18 at this time. 1147 ambulance here,started saline lock at 1150,Benadryl 50 mg given IVP by EMT. Client placed on g,urney and taken to hospital ER.
Information received from a nurse on behalf of consumer on 25NOV2013. A 44 year old male experienced headache, body aches, abdominal pain, and diarrhea. On 28OCT2013, the male received dose 15 of BIOTHRAX (Lot FAV429) intramuscularly in the right deltoid. Three days later, on 31OCT2013, he experienced nausea with headache, body aches, abdominal pain and diarrhea. The symptoms lasted approximately 24 hours, and on 01NOV2013 were considered resolved. The patient noted that he had experienced nausea and fatigue following dose 11 with BIOTHRAX.
Fever, uncontrollable shaking, throbbing pain radiating from injection site down the arm, pain across the chest, under the collarbone, in the shoulder joint, with pin prick like stabs of pain in the fingertips. Ice on injection site, over the counter pain meds (acetaminophen, aspirin), heating pad.  Pain in shoulder joint and muscles in upper arm persisting as of 11/17/2016.
Had hard vomiting for 6 hours, hives on chest and up neck, fever of 99, was "out of it" for 24 hours--was feeling better by the 30th.
Since receiving my booster I have tinnitus; Headaches 24/7; Dose number: 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 15Dec2021 at 09:00 (Lot number: FJ1620) at the age of 54 years as dose 3 (booster), single for COVID-19 immunisation. The patient relevant medical history was reported as "None". Concomitant medications included: OMEGA 3 and VITAMIN D NOS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP7534, Route of administration: Unspecified, Anatomical site: Left Arm, Administration time: 16:30), administration date: 18Mar2021, when the patient was 54 years old for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8735, Route of administration: Unspecified, Anatomical site: Left Arm, Administration time: 08:30), administration date: 08Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 09:00, outcome "unknown", described as "Dose number: 3"; TINNITUS (non-serious) with onset 15Dec2021 at 18:00, outcome "not recovered", described as "Since receiving my booster I have tinnitus"; HEADACHE (non-serious) with onset 15Dec2021 at 18:00, outcome "not recovered", described as "Headaches 24/7". Therapeutic measures were not taken as a result of tinnitus and headache.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Pt was seen 11-20-19 by employee for left arm pain, 2 weeks after the injection. she was diagnosed with injection site reaction and was treated with steroids. symptoms persisted. she returned to clinic and was seen by me 12-9-19 for continued pain in the left arm with severely limited ROM. I diagnosed with with brachial neuritis, treated her with NSAIDs and PT.
HPI: presented with weakness, congestion, sore throat, and trouble walking in the setting of COVID-19; pt tested positive of COVID on 9/21; developed congestion and sore through on 09/22 as well as sob and increasing weakness and numbness in legs. pt was afebrile at 98.2; tachycardi to 110 at tachupneic at 23; pt was not hypoxic; pt was severely hypertensive wat 214/117; given ativan for perceived panic attach and labetalol for hypertension which brough bp down to 150/87 no prior hx of hypertension Pt EKG showed sinus tachucardia with mild st depresion and t wave inversions in lateral leads.Troponin of 0.2; received aspirin and placed on heparin drip.  Hospital course: After admission, pt's extremities appeared mottled and it became difficult to get pressurs on him, he was then transferred to the ICU; dx with septic shock; ct a/p showed pyelonephritis, though blood cultures presumptivelu grew staph species on 09/26, pt had a hyperkalemic arrest and was resucitated, intubated, and sedated; pt was started on crrt due to worsening kidney function and hyperkalemia; potassium and lactic acid continued to rise, suspected necrotic process; pt was made dnr due to quality of life; pt had unequal pupils likely indicating neurologic dysfunction; after discussing with family,  he was transitioned to comfort care, extubated, and crrt was stopped. All meds that were not being used for comfort were discontinued. Pt expired 09/28/21 due to septic shock and COVID-19.
Took to ER.  Temp 103 vomiting, chills, headache to the point he was moaning, shaking to the point he could not walk.  ER gave him shots of morphine for headache.  Hands and feet ice cold.
Loss of taste; Wheezing; Cough; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), WHEEZING (Wheezing), COUGH (Cough), CHILLS (Chills) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 05-Mar-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 AGEUSIA (Loss of taste), WHEEZING (Wheezing), COUGH (Cough), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, AGEUSIA (Loss of taste), WHEEZING (Wheezing), COUGH (Cough), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
11/11/21 Janssen Covid Vaccine given to 16 yr old pregnant patient  EDD 2/14/2022.  Report written by vaccine administrator.  Written report scanned.  Attempted to fax form multiple times  between 11/11/21 to 11/15/21, however fax line busy repeatedly.    Report typed on Vaers form and submitted electronically on 11/16/21