chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from the patient's daughter referring to a 87 year old female patient. The patient's pertinent medical history included shortness of breath, slightly elevated temperature and symptoms of a cold. Additionally, the patient contracted the flu on an unreported date. Her historical drugs included acetaminophen (TYLENOL) that made her became pretty sick. The patient's concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one shot of pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown), for prophylaxis (route of administration, lot # and expiration date were not reported). Concomitant medications included influenza virus vaccine (unspecified). On an unknown date, the patient experienced pneumonia described as nosocomial. It was stated that the patient had it four times and she was treated several times for that (no details provided). At the time of reporting, the outcome of the event was unknown. The causality assessment between the event and the suspect therapies was not provided. Upon internal review, pneumonia was determined to be a medically significant event.  This one of two reports received from the same reporter and referred to the same patient (1809USA004780).; Sender's Comments: US-009507513-1809USA004780:
Patient recevied second dose of Pfizer/BioNTech COVID-19 vaccine; 5 to 11-year-old; NDC: 59267105504 on 12/11/2021. Patient passed out in chair 15 minutes after administration of the vaccine. Parents by her side. She was not harmed. Paramedics arrived, but she was not transported to a hospital.
On 10/23/02 patient received 3 shots and PPD. On 10/24/02, patient had rash (hives?) all over forearms.
This spontaneous prospective pregnancy report as received from a certified medical assistant (C.M.A.) refers to a 26 year old female patient with no pertinent medical history and no drug reactions/allergies. On 21-MAY-2014 the patient was vaccinated with the first dose of GARDASIL injection (lot # H020901, Exp date: 05-JUL-2015, 0.5 ml), intramuscular. No concomitant medication was taken. The patient was pregnant when she received the first dose of GARDASIL, with last menstrual period (LMP) of 25-APR-2014 (also reported as gestation: 7 weeks 1 day on 16-JUN-2014) and estimated due date (EDD) of 30-JAN-2015. Fetal ultrasound was performed. Initial exposure to GARDASIL was at 26 days. The pregnancy outcome was pending. No adverse effect reported. No treatment was given for the event. Additional information has been requested.
11:25am Patient complained of throat tightness and mild difficulty with swallowing then developed lip swelling.  EMS was called, epi-pen IM  and Bendadryl IM adminstered.  Patient transferred to emergency room.
Patient received 2nd dose of Moderna vaccine on 2/19/2021. On 3/22/2021 patient was tested for COVID-19 via nasopharygeal swab (PCR). This test returned positive. Patient does not have any symptoms of COVID-19.  Antigen and second nasopharygeal swab since 3/22/2021 have returned negative for COVID-19. Patient had tested positive previously 11/2/2020 and did have COVID-19 symptoms at that time.
OBSTRUCTIVE SLEEP APNEA 11/14/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA NEUROPATHY 11/14/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE CORONARY SYNDROME, UNSPECIFIED 2/23/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA
Patient getting covid symptoms after getting covid vaccine; Patient getting covid symptoms after getting covid vaccine; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (also reported as 41-year-old) received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was getting covid symptoms after getting covid vaccine on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
PT REPORTING BRUISING ON BOTH LOWER ARMS AND KNEES.  WAS WORKING ON HIS CAR, AND DID NOT BELIEVE HE HAD BRUISED THESE EXTREMITIES, BUT STARTED SEEING BRUISING ABOUT 48 HOURS AFTER THIS ACTIVITY.  FELT HE SHOULD ASK PHARMACIST AT VACCINATION SITE IF THIS MAY BE A CONCERN
Patient reports she received the booster vaccine yesterday evening. She had some mild aches/pains and some restlessness last night. A few hours ago, she developed nausea/vomiting, and her aches/pains intensified. She presented to the office for a Zofran injection which greatly resolved her nausea/vomiting. Her PCP advising she also takes 1000mg Tylenol TID for the next couple days to help with aches/pains. She understood.
On 5/16/02, pt developed fever. Ataxia developed on 5/18/02 with listlessness and fussiness. Ataxia resolved on 5/21/02.
seven months instead of six between shingles shots; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of shingles received 7 months ago from the time of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter reported that if he/she went 7th months instead of 6th months between his/her Shingles vaccine shot 1st and 2nd was he/she ok, which led to lengthening of vaccination schedule. Follow up would not be possible as contact details were not provided.
Pt was moved from vaccine area to observation area to a chair pt then passed out onto a table next to hair eyes wide open non responsive with faint to no pulse. 911 was then called and a dose of epipen given which brought the patient out of the unresponsive state within 30 seconds. Pt was then helped to the floor and observed until ems arrived.
This was reported to me by RN.  "Pt was vaccinated, stated he felt like he was "going to pass out," slumped over in his chair.  Was lowered to the floor in a sitting position by the vaccinator and another staff member.  Pt exhibited symptoms - clammy pale skin, sweating and some shaking of body.  B/P 60/30 HR 38."  Transported to the hospital.
This spontaneous report as received from a physician, via field representative, refers to a 59 years old female patient with asthma and drug allergies for Penicillin, Sulfa and SEPTRA. On 24-OCT-2012 the patient was vaccinated with a second dose of PNEUMOVAX23 (Product Lot number 1420AA, Expiry date unknown), route not reported. No other co-suspects were reported. No concomitant medications were reported. The patient called into the physician's office within 24 hours of receiving the vaccine complaining of pain in the arm; afterward she had developed the full symptoms of the cellulitis in the entire arm. The cellulitis was diagnosed on 26-OCT-2012. LEVOQUIN (500 mg for 7 days) was given for treatment. The outcome of cellulitis was reported as recovering/resolving. The relatedness for cellulitis is unknown for PNEUMOVAX23. It was reported that this was the patient's second dose; she's has multiple doses at her age because she is asthmatic, and these were recommended by her pulmonologist and not the internist listed in this case. The patient received the second dose of PNEUMOVAX 12 years after the first dose (given in 2000). Additional information has been requested.
chills; fever; body aches; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills and body aches on an unspecified date. The action taken in response to the event(s) for bnt162b2 was not applicable. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I'm in good health with no underlying problems other than osteoarthritis. Developed case of shingles. None of the typical symptoms that usually precede this disease. Only very severe sciatic pain the day before-Had 19 blistes-Took VALTREX=effective blisters lasted 7-10 days
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported for any of them. The reporter informed that on unknown dates, an unspecified number of patients were vaccinated with a dose of VAQTA intramuscular injection (dose number, route, anatomical location, batch/lot # and expiration date not reported). No adverse effects were reported. This is one of several reports coming from the same source. Additional information is not expected because neither the reporter nor the responsible physician wished to be contacted for further follow-up.
Extreme fatigue, muscle aches, shortness of breath, chest pressure, chest pain. Myocarditis.
I contracted COVID-19 on 07/04/2022 with symptoms of brain fog, fatigue, cough, loss of smell, stinging throat, hoarseness, chest congestion, congestion, sinus headache, lymph nodes were swollen, and ears were clogged. I was prescribed Benzonatate, Prednisone, and Doxycycline Bromocedephedrine  on 07/07/2022. I was ill for 14 days before my symptoms began to resolve. I am still experiencing lingering symptoms of fatigue, brain fog, ears are clogged, loss of smell, and chest congestion.
Began developing a fever and headache that progressively increased in severity over the couple hours in the evening and became significant enough he came to the ED. He presented with a 40 degree C fever, chills, rigors, and diaphoresis. He experienced a mild fever last year when he received the flu vaccine. No infectious source found. Treated symptomatically with ondansetron, morphine, and diphenhydramine, and dexamethasone. Given empiric antibiotics for a day. Discharged on the 10/24 with symptoms being resolved.
Moderna Vaccine lot #012H21B was affected due to out of temperature range. No adverse reactions from patients.  102 patient's affected.
10:55am Post vaccination reports feeling nausea, sob, w/ associated itchy tongue.; medical monitoring w/vital assessment P91 O2 sat 98% RA; no additional complaints or symptoms reported/ none noted. Reports "feels better" during monitoring w/symptom resolve; released from facility.
Day 1 induration about 6 cm, day 2 redness and induration with chills 8 x 7 cm at injection site.
Nurse administered high dose seasonal flu (65 and older) to  a healthy 11 year female. Nurse reached into the refrigerator bin  to use VFC flu for client  and instead took a High Dose Flu instead of VFC dose. 4 doses of Hi Dose had been left lose in bin. Nurse failed to read label or note lot number prior to administering flu shot. Label colors on  VFC Flulaval single dose and Sanofi single Hi Dose are similar in color(both blue).  Child reports no adverse  side effects as of 72 hours post vaccination.  Nurse was written up for not checking labels or lot numbers prior to administering and another staff member who left High Dose flu unlabel also written up. Immediate report occured by nursing supervisor to Medical director and parents were notified by nurse.
12 year old boy was administered Afluria at the request of parents.  Upon administering Afluria the patient immediately fainted while sitting and awoke within a few seconds.  Water was given to the patient upon awakening and time to rest. His blood pressure was measured after resting for about 5 minutes and measured to be approximately 60/40. After an additional 5 minutes his blood pressure was tested again and measured at 90/60.  A third measurement an additional 5 minutes later was taken and found to be 112/60.  I believed the patient had experienced a temporary episode of syncope and was slowly recovering.  The patient was very nervous upon receiving the vaccination and I encouraged the patient to relax. I stayed with patient approximately 30 to 40 minutes to ensure that his blood pressure was normalizing and healthy enough to safely leave with his parents. I recommended that the parents have the patient examined by a physician to ensure the patient's health and parents' peace of mind.   Approximately 1 1/2 hours after the patient leaving the pharmacy I followed up with parents and was told the child was being taken to health care facility for examination.  The following day I called the parents twice but no return call.  I received a call back from the mother 3 days after the initial episode and was told the patient may have experienced a seizure.  There is no seizure history on the patient from pharmacy records. The patient had received a follow up examination at an ER room according to the mother.
March 18 2021 my mom received her first Pfizer vaccine followed by her second on 4/03/2021. After she received it she started having an overall feeling of not well. Tired, fatigue, headache, and complained to her doctor on multiple occasions. Since 12/09/2020 she had only went to the doctor one time on 02/08/2021. After the first dose until her death she had gone to her doctor many times, on 03/30, 04/01, 04/21, 04/28, 05/25. That may not be a complete list of every visit.
My daughter was only 10 years old when she got vaccinated with GARDASIL. She is now suffering from cold urticaria, also called cold,  hives, because of GARDASIL. THis will affect her entire life. Because of this horrible side effect, she can not do many things that she used to. For example, she will not be able to be in the swimming  team, because everytime she gets in the cold water she gets hives. When she goes out in the cold weather, she gets hives. The hives are red small and large bumps that itch terribly and come out all over her body, including her legs, stomach, back and arms. They last from a whole day to almost a week sometimes. I do not recommend anyone take this vaccination and a warn parents to not let their chidren doctor convince them to take it. I regret ever letting them give this shot t my daughter, but I was told it was s mandatory shot that needed to be given in order for my daughter to go to school.
Patient with history of anaphylaxis to other medication (not identified to EMS who were treating her). Had immediate tongue welling post vaccine. Benadryl administered by injection (EMS) and she was transported to a hospital.
post-herpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown gender who at the time of report was approximately 71 years old. No information was provided regarding the pt's medical history, concurrent conditions, or concomitant medications. On or about 17-NOV-2014, the pt was vaccinated at a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post-herpetic neuralgia. The outcome of the events was not reported.  The reporter considered the events of herpes zoster and post-herpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).
Ganglion cyst; This spontaneous case was reported by a consumer and describes the occurrence of SYNOVIAL CYST (Ganglion cyst) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNOVIAL CYST (Ganglion cyst). At the time of the report, SYNOVIAL CYST (Ganglion cyst) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Drugs Not Reported.  Treatment Drugs Not Reported.  The reporter's causality for the event(s) of GANGLION CYST with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   Reporter did not allow further contact
she feels like she is having the flu; headache; feeling horrible, feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (she feels like she is having the flu), FEELING ABNORMAL (feeling horrible, feeling terrible) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 039B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (feeling horrible, feeling terrible). On 29-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (she feels like she is having the flu) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (she feels like she is having the flu), FEELING ABNORMAL (feeling horrible, feeling terrible) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concimtant drugs were reported.   This case was linked to MOD-2021-402920 (Patient Link).
Pain, erythema, heat at vaccine site (left deltoid) 24 hours after peaked at approximately 48 hours. Started on oral Septra better (improving not gone) at 72 hours.
Pt recvd Hep B vax & exp unspecified reaction; @ time of report, pt had recovered; no further details were provided;
On 03/19/2021 I had an headache that lasted a week. On 03/20/2021 I started experiencing IBS which I am still having to this day. On 04/10/2021 I developed neuropathy in my face, hands, and feet.
This is a spontaneous report from a contactable Nurse (patient). A 37-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine; solution for injection; Lot Number: EN6199), via an unspecified route of administration, on 08Mar2021, as 1st dose, single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that within the last week and a half, she had been experiencing arm pain and sensitivity at the injection site, on an unspecified date in 2021. She stated that she received one dose in each arm, in which both arms were experiencing pain. She did not have much arm pain after the first dose. On 29Mar2021, the patient received bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8730), via an unspecified route of administration as 2nd dose, single dose, for Covid-19 immunization. The patient stated that she was calling about the Pfizer vaccine. she clarified she was referring to the Covid 19 vaccine. she stated she was just called because she received the Covid vaccine shot in March and she had suddenly in the last week in a half been feeling arm pain. Caller stated she got the shots in different arms but now she was having sensitivity in both sites where they put the vaccine. The patient asked if there was any more data collected on "keeping antibodies in her system." MI agent confirmed if caller is asking about the duration of protection in which caller answered yes. The patient also asked if there is a need for a booster dose (3rd dose) for the Pfizer Covid-19 vaccine. The patient was not recovered from the event arm pain after the first dose/ initial arm pain and outcome of She is having sensitivity in both sites was unknown.  Information on the lot/ batch number has been requested.
Initial unsolicited report received from a nurse on 16-MAR-2017. This case involves a 40-years old female patient who was vaccinated with a dose of ACAM2000 (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 04-AUG-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA) and Illness at the time of vaccination was reported as not applicable. Any other vaccinations within four weeks of vaccinations were also not reported. Concomitant medications were not reported. On 14-AUG-2016, 10 days of following the vaccination, the patient had developed pain and wrist swelling in arm opposite of vaccination site. The patient did not required emergency room (ER) or doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as recovered. List of documents held by sender: none.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot#, dose#, dose and route unspecified). No adverse symptoms reported. No product quality complaint was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Developed petechial hemorrhages on 10/13/2009. Seen on 10/16/2009. Platelet count was <3000/ml, otherwise normal RBC/WBC, consistent with ITP. Given IVIG with increase in platelet count to 26,000. Ongoing follow-up. 11/20/2009 MR for 10/16-10/17/2009,Dc Dx Thrombocytopenia   patient with petechial rash, itching and bruising. CBC noted low plt ct, Tx: IV IGg
Tightness and pain in the chest, increased heart rate, difficulty breathing. Patient called 911.
Headache; shakes; shivers/Chills; throwing up/vomiting; quit eating things; Bad taste in his mouth; Cold; This is a spontaneous report from a contactable consumer or other non health professional (Parent) reported for a patient(son). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Jun2021, the patient experienced headache, shakes and shivers/chills; throwing up/vomiting; quit eating things; bad taste in his mouth and cold. Reporter stated that he had headache at school the next day, he had the shot yesterday. Today real bad headache and stuff at school today. He came home and started having shakes and shivers. Then he started vomiting, throwing up, quit eating things. Had bad taste in his mouth. (distorted voice and unclear) but then he had problems like cold, chills, shakes in it. Reporter wants to know why patient was having chills, shakes and he was throwing up. The outcome of all events was unknown.  Information on the lot/batch number has been requested.