chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 05-MAR-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain  of herpes zoster. On or about 01-AUG-2013, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse refers to a 9 month old patient (gender unknown). No medical history was reported. On 03-AUG-2012, the patient was vaccinated with a dose of VAQTA (lot # H010145, expiry not reported) intramuscularly when the patient was nine months old. No concomitant medications were reported. No adverse effect reported. The nurse inquired on lot # H010145 as to whether it is a Hepatitis A or Hepatitis B vaccine. Nurse also inquired if the vaccine VAQTA can be counted as it was given to the patient early. Additional information has been requested.
Patient was queried about receiving flu vaccine by both the Medical assistant and Physician and requested to receive it.  After is was administered, whiel recording in chart, a flag came up that the patient had previously received High Dose Flu vaccine on 09/23/2021, Lot # UJ732AA
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Severe, Additional Details: Pt reported severe redness swollen, itchy, warm to touch at injection site. Symptoms started 1 day post injection and have been very severe. Pt is also immunocompromised and on injectable biologics. She will follow-up with her rheumatologist for further management of symptoms
Chest heaviness; Hot flashes; Ached; Chills; Fever; Headache; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 13Apr2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included mesial temporal sclerosis (MTS), antiphospholipid syndrome (APS) and clot blood. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took ibuprofen sodium (IBUPROFEN) on an unknown date for an unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 23Mar2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included multivitamin, probiotic, warfarin sodium (WARFARIN), vitamin d nos (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN); all for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 02:00, the patient experienced sore arm, hot flashes, chills, fever, headache, ached and chest heaviness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of sore arm, hot flashes, chills, fever, headache, ached and chest heaviness was recovered on 14Apr2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from an office manager concerning a 13 year old female who was vaccinated with a first dose Gardasil early in the day.  On the same day, at approximately 21:00, the patient developed a "rash all over her body."  When the patient was seen by the physician, she was sent to the hospital.  No further follow-up was done by the office.  No further information is available.
Chills; acid reflux; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL8982, via an unspecified route of administration, administered in left arm on 05Feb2021 as single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 on 14Jan2021 (lot number: EK9231) for COVID-19 immunization. The patient mentioned that she had to go to the doctor with acid reflux on 06Feb2021. She was taking some medication for the acid reflux and it was getting better. On 12Feb2021, the patient was having some chills. The patient was feeling a little bit better because she took a Tylenol. The outcome of the events was recovering.
CHILLS, FEVER, HEADACE, NASEA, NO APPITITES AND FATIGUE
The patient received their 1st dose of the COVID-19 vaccine even though they were not yet 16 years old. This error was discovered at the time of checkout when trying to schedule for dose #2. The computer system flagged it and would not schedule the 2nd dose due to the patient being <16 years old. I was then notified of the error. This patient had been an add-on to the clinic and did not already have an appointment for the future so he was added into the system just prior to getting the vaccine. The patient came with his father and completed the Prevaccination Checklist and it was marked as age 16. The RN administering the vaccine had the father complete and sign a parental consent form. On this form, the DOB for his son was listed but the RN did not catch that the patient was 4 days away from turning 16. The RN reviewed the checklist and signed and dated it and proceeded with the vaccination. There were no contraindications marked on the form. The patient waited the 15 minutes following vaccination and did not experience any negative side effects during that time. When I was notified of the error, I spoke to the patient and his father and explained that he should not have received the vaccine due to his age being <16 years old. I also told them I would be following up with the RN that gave the vaccine and that I would be filing a report and I got the father?s phone number and said I would call if there was any other info that I needed. They were instructed to wait until after patient turned 16 years old to call the rescheduling number and then make an appointment for his 2nd dose. I followed up with the RN and with the check-in staff to make sure to screen people carefully to make sure they are at least 16 years old.
pounding headache; Body aches; Fever; Stiff neck and pain; This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 vaccine, Batch/Lot number: Unknown), via an unspecified route on an unknown date (Thursday) as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were unknown. On an unspecified date in May2021 (Thursday around 10:00), the patient experienced pounding headache and then she went home and later on that morning (around 15:00) patient had body aches, fever, and then the next day she had a stiff neck and pain/sore neck. It was unknown if the patient received any treatment for the events. The outcome of the pounding headache, body aches and fever was recovered in May2021 while for the stiff neck and pain was unknown.  Information about lot/batch number has been requested.
Rotarix was inadvertantly administered to patient via IM on right thigh   Provider and LPN notified at the time of the appointment as well as the parents. LPN followed up with parent the next day patient has slight redness.
Irregular menstrual cycle. I believe the vaccine has affected my menstrual cycle in making it very irregular. My period used to start like clockwork every month but now it's at least 6 days late or extremely early.. I'm not on any birth control and have never been pregnant or had a miscarriage.
The day of receiving vaccine patient reports having weakness and fatigue.  Then during the night developed sudden and acute onset left lower extremity weakness.  Immediately went to the ER for further evaluation.
itchy face Narrative: Moderate anaphylaxis reaction after administration of dose #1 Pfizer covid-19 vaccine. Tongue swelling and facial itching. Epi administered xl, patient transported to local ER for follow-up care.
Site: Pain at Injection Site-Severe, Systemic: painful arm-Severe, Additional Details: Patient is complaining of painful arm, can't lift arm up
KNOT UNDER LEFT ARM; PAIN IN LEFT ARM; PAIN IN SHOULDER; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the subject experienced knot under left arm. On 15-MAR-2021, the subject experienced pain in left arm. On 15-MAR-2021, the subject experienced pain in shoulder. On 15-MAR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in left arm, terrible headache, pain in shoulder and knot under left arm was not reported. This report was non-serious.
Patient came attesting over age 16 however was only 15 years of age when receiving the COVID 19 Pfizer vaccine. Patient did not experience any adverse side effects while being monitored nor did patient report any adverse side effects
pt recvd vax 13OCT92 & 20OCT92 was seen in an ER w/sx of lt eye redness which felt sticky; treated w/garamicin; 29OCT92 was seen by opthamalogist who dx scleritis; 2NOV92 was treated w/ASA for pain; pt devel conjunctivitis;
This spontaneous report was received from a medical assistant and refers to a 38-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-APR-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017; dose and route of administration were not provided). The vaccine underwent a temperature excursion of either +1 or -1 degrees Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Seizure-like activity lasting approximately 15 seconds. No memory of event upon awakening. No further signs of seizure activity once taken to hospital. Awoke with lightheadedness and nausea.
Extremely high fever. Culture (blood) taken in ER on 10/9/03. Positive for Streptococcus pneumoniae. Culture sent to CDC to identify strain. Possible vaccine failure.
seizure; This is a spontaneous report from a contactable nurse (parent of the patient).  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 13May2021 at 11:00 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE (at the age of 27 years old) for covid-19 immunisation.  Medical history included depression from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) taken for depression at 150mg once a day from Apr2021 (reported as 2 weeks prior to vaccination date) to May2021 (stopped after she had the seizure).  The patient experienced seizure on 14May2021 at 13:00 with outcome of unknown.  She had no history of seizure activity. No family history of seizures. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date, computerised tomogram: normal on an unspecified date, electrocardiogram: normal on an unspecified date, and electroencephalogram: normal on an unspecified date. The event required emergency room visit and physician office visit.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of seizure due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head  MRI, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.  ,Linked Report(s) : US-PFIZER INC-2021605934 Same reporter/drug/event, different patient.
high blood pressure  severe chest pain  Dizziness Rash on arm Burning sensation throughout my body
Tiredness,chills,dark bruise on right forearm 4 inches in diameter,headache that lasted for about 5 days after first vaccine shot
chills, joint pain, swollen red-hot arm @ site (shoulder-elbow);cellulitis rx w/keflex, pred; sign sx significant dec p/24hr on meds;
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.
Red, swollen, pain, and tightness in injection site 7 days after receiving vaccine.  Tired, extreme fatigue began within 2 hours after receiving vaccine and lasted for 7 days.
Received dose around 5pm, by between 7-8pm I had body aches, and severe chills - almost to the point of convulsion. Woke up with a fever in morning, fever off and on the following day, fatigue the following two days. By day two I was having difficulty breathing while laying down, shallow breaths. I went to urgent care by the fourth day because the breathing difficulty increased, to the point where it was hard to breathe sitting up. Dr. at the urgent care did chest Xray and EKH, which were both normal. He tested me for COVID-19 and the results were negative. It is now day 7 and I am still having shallow breathing, with what feels like an unclearable chest congestion, and cough.
Yesterday our LVN was giving a vaccine shot with a retractable syringe . As she was injecting the vaccine into the members arm she pushed the medicine in and the retractable sound seemed louder than usual. When she looked at the arm it was a wet spot on the member's arm. The nurse called me to look at the member's arm. I noticed a small wet spot on the member's arm. I didn't feel it was enough to repeat the dose. The member was aware and left. The day before  (4/4/2022) a similar incident happened when the LVN went to give a vaccine injection to another member she states that when she went to push the vaccine in the arm the needle retracted right away and the vaccine splashed back on her uniform and down the member's arm. She states it also made a louder than usual sound when the needle retracted. The member was given another full dose of the pfizer vaccine at that time.
Information has been received from a physician assistant concerning a 72 year old female with drug allergies to codeine, penicillin and FLAGYL and no medical history, who on 14-SEP-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 664634/0742Y, expired date 23-NOV-2010). Concomitant therapy included "thyroid", calcium, aspirin and EVISTA. On 22-DEC-2010 the patient experienced pain and burning followed by a vesicular rash on the left side of her neck toward deltoid area of shoulder. The patient was seen in the office on 28-DEC-2010, diagnosis shingles. Treatment given for this AE included VALTREX 1 GM three times a day. No lab diagnostics studies performed. At the time of reporting, the patient's status was not recovered. Additional information has been requested.
severe itching; severe case of hives/urticaria; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001260 (Novavax).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "recovered", described as "severe case of hives/urticaria"; PRURITUS (non-serious), outcome "unknown", described as "severe itching". Therapeutic measures were taken as a result of urticaria.  Additional information: The patient had a severe case of hives that lasted 2 days with an unspecified antihistamine treatment.
Confusion, Headache, itchy red, swollen at injection site;fatigue  Narrative: Headache, fatigue, red, itchy warm swollen injection site, disorientation; 72 hours resolved.
Red Spot; I just feel like itchy. My back is itchy; Neck is hurting; Headache; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number was ER8731, expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure (she was under control and then she was waiting to see by giving biopsy for possible cancer of thyroid), diabetes mellitus, migraine, gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medications included metformin, lisinopril, glipizide, omeprazole start and stop date were not reported taken for an unspecified indication, amitriptyline taken for migraine, galcanezumab gnlm (EMGALITY [GALCANEZUMAB GNLM]) taken for migraine, biotin, colecalciferol (VITAMIN D3), vitamin E NOS (vitamin E), vaccinium macrocarpon (CRANBERRY), calcium taken for an unspecified indication, start and stop date were not reported. On 25Apr2021, the patient experienced headache. On an unspecified date, the patient experienced red spot, I just feel like itchy, my back is itchy; neck is hurting. She had got another spot on her ribs on the opposite side, and she still feel itchy and the headache in her neck on the opposite side. The patient underwent lab tests and procedures which included chest X-ray, ultrasound thyroid, sinus X-ray was done and where the result was unknown. Reporter stated that he was waiting to see by giving biopsy for possible cancer of thyroid. When probed for the results consumer stated they said they found the two nodules, so she was waiting for biopsy to see what was going on. The patient was not received any treatment for the events. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pain on arm site.  Fever, chills, body ache, Rapid breathing. Since vaccination my menstrual cycle has been heavier with clots, migraines have increased, I can't run as fast, I'm out of breath, and suffer with some insomnia.
Left side of the body feels weird, feeling odd; Feeling lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Left side of the body feels weird, feeling odd) and DIZZINESS (Feeling lightheaded) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced FEELING ABNORMAL (Left side of the body feels weird, feeling odd) and DIZZINESS (Feeling lightheaded). At the time of the report, FEELING ABNORMAL (Left side of the body feels weird, feeling odd) and DIZZINESS (Feeling lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
received Boostrix, DOB: 04-JUL-2013; received Boostrix instead of Flu vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN).   On 9th November 2021, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter stated that, the patient received Boostrix vaccine instead of Flu vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administration. The reporter consented to follow up. This is one of four cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231230:SAME REPORTER US-GLAXOSMITHKLINE-US2021231231:SAME REPORTER US-GLAXOSMITHKLINE-US2021231229:SAME REPORTER
Patient c/o swelling and pain and redness at injection site. Pt went to his PCP who told him to monitor site and if it did not go away he would put him on antibiotics. It is getting better without antibiotics.