chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. No information regarding patient's concomitant medication, pertinent medical history, drug reactions, or allergies was provided. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (dose and route of administration, were not provided; lot #: L040181, expiration date: 18-AUG-2017). No adverse events were reported. Additional information has been requested.
pain in her arm; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves an unknown age female patient who experienced pain in her arm after receiving vaccine Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, dose, route, frequency: unknown) (lot number and expiry date: not reported) in unknown administration site prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of pain in her arm (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, reporter attempted to transfer the caller to Medical, however the caller was very adamant she was not helping with our experiment. Reporter tried to explain all adverse reactions need to be reported (I hope I got that right) but the caller stating that is only going to help us and not her. She disconnected the call. Reporter know this needs to be reported, but do not have any information.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (pain in her arm).  At time of reporting, the outcome was Unknown for the event pain in her arm.
Patient was given Tdap at 2 month well child check; instead of DTaP.
woke up next day with "splotches" right side nipple area. Progressed to right under arm & right back area. Itchy & painful. He went to his PCP's office & saw NP. Diagnosed with shingles & started on medication. In process of recovering now.
Soreness, slight fever, body aches, headache, chest pain, abnormal heart rhythm
Initial report received from a health care professional on 13 Aug 2010: This patient was vaccinated with MENVEO (batch number 100001), intramuscularly, on an unspecified date. The reporter stated that the patient was administered with only 0.4ml of MENVEO (correct dose is 0.5 ml). However, no adverse events occurred. The outcome of the event was not reported.
Pt was given BEXSERO and MENACTRA one month prior to this vaccination event. Later in the evening pt developed generalized muscle aches, low grade fever, and malaise. Pt had also played in a high school baseball game following administration of vaccine.
Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 10-FEB-2014, the patient was vaccinated with an improperly stored dose of VAQTA, lot # J006521, expiration date 23-AUG-2015 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions for two times. The storage criteria and the type of excursion (R/F) were refrigerator (R). The lowest recorded temperature (Fahrenheit degree (F)) and total cumulative excursion time (hour) were as following: 34 F for 80 hours and 33 F for 336 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fever (101) and rash. Patient also received varicella Vaccine and Hepatitis A vaccine at the same time.
This spontaneous report was received from a 78 year old female patient who refers to herself. The patient had no pertinent medical history and did not receive any concomitant medications. The patient had drug reactions and allergies to penicillin, codeine and rifamycin. In September 2012, reported as about 5 yers ago, the patient was intravenously vaccinated with a single dose of ZOSTAVAX (dose, lot# and expiration date were not reported) for shingles prevention. Since September 2013, about a year after receiving ZOSTAVAX, the patient experienced shingles 4 times. The patient sought medicall attention. She received treatment all four times and used topical creams and 800 mg of acyclovir. No lab diagnostic studies were performed. The outcome of shingles was unknown. The relatedness between the event of shingles and ZOSTAVAX was not reported.
Tested positive for Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 positive test in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Tested positive). At the time of the report, COVID-19 (Tested positive) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Symptoms started to appear on the 6th of April. Reporter wasn't sure of concomitant medications and treatment information.
PT rec'd grey cap pfizer after it was stored in freezer for 22 days- replacement dose was given on 6/2/22
redness; itching in arm and leg with tiny red bumps. Also felt itchiness in left cheek but no redness.; itching in arm and leg with tiny red bumps; This is a spontaneous report received from a non-contactable consumer (reporting on herself). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not re-ported. It was reported that patient never had an allergic reaction before she got second dose of BNT162B2 vaccine on left arm. 10 min after reported redness, itching in arm and leg with tiny red bumps. Also felt itchiness in left cheek but no redness. Next morning still had same symptoms. Only took Tylenol. And was asking anyone else experience this. Patient was asking any % of people who got fully vaccinated and got re infected with covid. Saying that been told she should isolate for 14 days after the dose. Asking if that true and wear a mask. The outcome of the events was un-known.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
General body aches, tiredness, feverishness (but no actual fever) headaches, occasional nausea. Began +/- 5 hours after the shot, increased through the night and through the entire next day. Subsided the following night
noted redness w/swelling in a couple of hrs p/vax;next day redness, swelling, tenderness @ site of inj;pt was seen that day by MD;MD felt poss infect present;
Deep venous thrombosis and bilateral pulmonary embolism approximately one week after administration of vaccine leading to hospitalization on 4/24/21
bump or bulge on his back end; bump feels very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Dec2022 as dose 4 (bivalent), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, first boosted dose in May and didn't have any problems at all.), for Covid-19 immunization.  The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "bump or bulge on his back end"; PAIN (non-serious), outcome "unknown", described as "bump feels very sore".  Patient got the shot on 26Dec2022 and few days later a bump came on his back, and it was sore. Two or three days later, he noticed a bump or bulge on his back end. The bump feels very sore. Asks if this is a side effect of the vaccine. He states he had the first two of the primary series and the first boosted dose in May and did not have any problems at all.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 11/16/08, pt went about her day as normal, but became very tired quite suddenly around 5:00 in the evening.  She went to bed to rest (something she rarely did until this point).  After a couple of hours we attempted to wake her to attend church, a favorite activity, and she wanted to continue sleeping.  We let her sleep until the next morning. We made her get up and prepare for school, but before she left, she complained of tiredness, headache, and sore throat, and we allowed her to stay home from school.  She remained in bed for ten days, only getting up to go to the bathroom, shower, or go to the doctor.  We encouraged her to sit up in a chair or even lie down in another room to help increase her energy level, but she did not have the strength for more than a few minutes.   During this time the headache and sore throat remained, along with upper abdominal pain (left side right under ribs).  The symptoms gradually improved, and pt was much better by the end of the first week of December.  From then until the middle of January, pt continued to report mild symptoms, including fatigue and abdominal pain, but she was able to go about her normal activities.  In mid January, pt came home from school, went to bed, and would not get up until morning.  She went to school the remainder of that week with moderate symptoms, only because she was taking mid-term exams.  Since then, pt has had three more occurrences of symptoms, missing one and two days of school.  During these periods she has complained that light hurts her eyes.  Upper abdominal pain, headaches, and sore throat recur periodically.  Pt has also complained of periods of "feeling out-of-it", or not being able to concentrate at different times since mid-December.  She has also stated that her legs "fall asleep" often.  To the best of my knowledge, she has never had fever during this time.  In July she received five injections (HPV/Meningitis/DPT/Varicella/HepA), and two in October (HPV/Influenza).  Lot number for July 2008 HPV vaccine was 1757U.  Lot number for Meningitis vaccine was U2636AA.  8/17/08 PCP Medical records received DOS 7/15/08 to 12/01/08. Assessment: Viral Syndrome. Patient presents with fatigue, sore throat, abdominal pain, headache, achiness, mild nausea.   8/18/08 PCP Medical records received DOS 12/03/08 to 6/11/09 Assessment: Abdominal pain, fatigue. Patient presents with continued fatigue, nausea, and left-side upper abdominal pain. Tenderness to palpation left upper quadrant abdomen. Diarrhea. Knee pain, headaches. Ankle abrasions. Infections disease consult. Gastroenterology consult.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Patient just got over COVID. No treatment information was provided.
Information has been received from a physician concerning a "few adult pts" who were vaccinated with a 1st dose of varicella virus vaccine live. Subsequently, the pt developed a vesicular rash that consisted of less than 50 lesions. The pts sought unspecified medical attention. Additional information has been requested.
Patient called with extreme fatigue and pain in her right arm. Patient claimed that she could not move her right arm. Counseled the patient to ice her arm and take ibuprofen and to seek medical help if condition worsens.
This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 40, via an unspecified route of administration, in the left arm, on Mar 10, 2021, at 15:00, single dose, for COVID-19 immunisation. No medical history or no known allergies reported. The patient did not take any concomitant medications. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On May 10, 2021, patient had period-type bleeding every two weeks. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of having period-type bleeding every two weeks: not resolved (at the time of report). No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Several episodes over few days, afebrile, VSS 1-2 seconds both eyes rolled up, patient appears to hold his arms and legs still then resumes all movement of extremities the episodes witnessed by mom, 6 h and MD = lasted about 2 weeks.
3-4-08 shingles vaccine. 3-17-08 Catheter ablation surg. Rt leg with accidental 2nd Deg. burn wound at cath. insertion site. 4-18-08 multiple vesicles, erythema, pruritus, deep pain at cath insert site. 4-21-08 Dr Rx Altabax 4mg; AVELOX 400mg x 10 days
pt recv vax 14MAY98 & 16MAY98 pt T102.3, adenopathy, pain in joints;
Patient had an episode with convulsions and loss of consciousness lasting a couple seconds after eating a marijuana edible.
On April 3, I had a brain hemorrhage. I was doing my normal Saturday morning activities - ate breakfast, did a few simple things around the house, then was doing some light floor exercises. While doing my usual light exercises, I suddenly felt "off" then took a bath. While I was in the bath, I realized that something was wrong with my vision and I had someone take me to the emergency room. I had lost half of my vision as well as experienced significant memory loss, loss of fine and gross motor control, issues with my speech and use of language, unable to do simple math, could not remember or figure out how to use a cell phone, and severe balance and dizziness issues. I spent a week in the hospital, most of that time in the ICU.  After being discharged from the hospital, I needed full-time care for over a month, then still needed a caregiver most of the time for several more months. I started intensive physical, occupational, and speech therapy at a specialized neurotherapy center, which has continued for 6 months.  I have continued to see my neurologist, neuro-ophthalmologist, ophthalmologist, and primary care doctor on a regular basis. They have done numerous tests, including CT scans, MRI scans, MRA scans, vision field tests, tests for my retina and optic nerve, and blood tests. Through all of this testing, they were not able to determine a cause and I have none of the risk factors for having a brain hemorrhage.  I am continuing to do therapy at home, including physical, occupational, speech, and vision therapies. I am not fully recuperated, still not able to work, and the doctors do not know if I will fully recuperate.
This spontaneous report as received from a pharmacist via company representative refers to a 57 year old male patient. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot #, expiration date, dose and route were not reported). The pharmacist reported the patient experienced an injection site reaction (redness, swelling and pain in the injection site) following administration of PNEUMOVAX23 on unspecified date. The outcome of the events was unknown. The causality was not provided. Additional information has been requested.
Pt is a 13 year old male who received the wrong dose of covid vaccine. He should have received the Pfizer 12+ covid vaccine but was accidentally given the 5-11year Pfizer covid vaccine. Pt tolerated the shot well and is doing fine, just given wrong dose
Grandmother noticed redness and swelling of (L) arm several hours after injection. Pt was given TYLENOL and ice on site for discomfort. Pt con't to c/o pain in (L) arm. Encouraged MD evaluation.
This case was reported by a consumer and described the occurrence of injection site soreness in an adult female subject who was vaccinated with ENGERIX B, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  On 19 July 2008, the subject received 1st dose of ENGERIX B (unknown, left arm).  On 19 July 2008, less than one day after vaccination with ENGERIX B, the subject experienced injection site soreness of the left arm.  After an unspecified amount of time, the event resolved.  The caller was reported on behalf of the vaccination subject, and had minimal information to provide.  The reporter stated that the vaccination series was neither discontinued nor delayed, but was unsure if the subject checked with her physician for treatment.  Please reference report A07466B1B.
Immediately after receiving vaccine, patient slumped over. Dad said she never lost consciousness. She started shaking/convulsing for about 5 seconds. At that point I requested we call 911. A technician was able to speak with EMS and direct them to the store. While waiting, patient began speaking with dad. She was able to answer his questions. She began to develop a rash on her arms. At that point EMS was arriving. All over the course of about 10  minutes.
Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; This is a spontaneous report from Pfizer-sponsored program. A contactable Other HCP reported for a nurse (patient). An adult female patient received bnt162b2 (batch/lot number and expiration date not provided), via an unspecified route of administration, first dose on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter has a patient and the patient is having the symptoms of UTI after the patient got the first dose of COVID-19 vaccine on Monday. The patient who is a 30 year old female (Age at the time of adverse event was not confirmed) who got her vaccine on Monday. She is a nurse and she developed urinary tract infection (UTI) symptoms of burning in urination and frequency and urgency and a urine sample was sent for evaluation, if it is positive the patient was wondering if the vaccine response would be altered by taking antibiotics for UTI. The outcome of the events was unknown  Information on the lot/batch number has been requested
2nd dose Moderna Vaccine on the afternoon of 20-Jan-2021. Woke up in the early AM with severe arm pain and headache. took 1000mg Tylenol. Over the next few days the headache increased in intensity and became debilitating by Saturday the 23rd of January; severe headache x 3 days, mild body aches and low-grade fever [x 36 hours]. Very little pain relief from Tylenol 23rd-25th.  I also had nose bleeds that started on the 23rd which resolved by the 25th. The headache had resolved by the 29th of January.
Twelve Moderna vaccines were given in office. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. (Case #). Employee in Quality was also notified.   Communication to patient: The Moderna Vaccine the patient received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. Patient will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
On the 12th day after the vaccination, I developed Tinnitus in both ears.  This has continued until the present day.  I saw two different ENT doctors.  Both did audiology tests and examined my ears.  They could not see any fluid in my outer ears and my hearing was only slightly reduced.  They could not find a cause for my Tinnitus.  I have never had Tinnitus prior to this.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date later in 2013, the patient was treated by a physician for vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.