chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information and additional follow up have been received from a physician concerning a mixed race five year old female patient with cerebral palsy, developmental delay and a history of recurrent herpes simplex, who on 9/11/00 was vaccinated with a dose of varicella virus vaccine live (lot # 634514/0539K). There were no concomitant medications. At the time of vaccination, the patient had otitis media. On 8/10/04, the patient developed a breakthrough case of chicken pox described as less than 50 lesions. The experience was further described as a rash consisting of small red bumps on the patient's abdomen, arms, legs, and she had itching. It was noted that she also had mild rhinorrhea. The patient was treated with oral diphenhydramine to control the itching. It was noted that no laboratory tests were performed and the patient had no adverse events following prior vaccination. The patient recovered on an unspecified date. There was no product quality complaint involved. Unspecified medical attention was sought. No additional information is expected.
pain on right side in chest area, shortness of breath, cough taking ibuprofen 600mg, using heating pad to release muscle tightness
On 4/16/21, patient reported that following vaccination on 4/8/21 around 9:45 am: ..."The feeling of being light headed began around 10:30  am while I was sitting at my computer.  Six days after the vaccine, I actually went to bed with severe cold chills which lasted several hours.  I am still experiencing intermittent periods of "brain fog" or at times feeling a little light headed.  Last Saturday was the only day that I haven't experienced feeling this way.  Again, it does not happen all of the time but it is bothersome. I am hopeful that after this Thursday (2 weeks will have passed since the vaccine) that symptoms will disappear. If not, I will follow up with my family practitioner.  Thank you!"
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 24-SEP-2015 at the health department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUL-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 27-JAN-2017 the patient was treated again at the medical center for new outbreaks and worsening symptoms of shingles infections. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
On July 15th at 06:00PM, I had extreme fatigue and body aches. On July 16th, I woke up with "faucet face". I had sneezing, runny nose, stuffy sinuses, crying eyes, and a cough. I skipped dinner and slept for about 9 hours, but I woke up feeling the same. I was able to eat breakfast but that was about it. I picked up a COVID-19 test at a pharmacy while I was traveling, and it was positive. I stayed home for the next week. On the 4th day, I called my doctor for an appointment. She prescribed PAXLOVID. I took 6 pills daily for 5 days. One the 27th, I tested negative.
13x12cm erythematous and essentially indurated swollen area of left upper arm. Slightly warm compared to the side. Itchy. Treatment given - KEFLEX 250 mg/5m twice daily for 5 days can also give BENADRYL and cool compresses.
Death Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was hospitalized in early 02/2021 at Medical Center in the ICU for a bleeding ulcer. Was inpatient for over a month, but do not have records due to it being outside facility. Received a colonoscopy report which showed. diverticulosis and CT of abdomen showing pleural effusion, umbilical hernia and gallstones. Notable comorbidities include emphysema, CKD, CAD, ICM, and T2DM.
numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear.; numbness and tingling on left side of face, around left eye; numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 08:55(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no chronic illness. The patient did not take any concomitant medications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 9:00, the patient experienced numbness and tingling on left side of face, around left eye, forehead, skull, and left cheek/ear. Within about 10 minutes of symptom onset, intensity subsided, but still felt lingering slight numbness. The patient had no dizziness and balance was fine. The patient still felt slight/lasting numbness in affected area at the time of this report(11:15).On 30Mar2021, the blood pressure and oxygen saturation was reported as normal.  The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of numbness in face, eye numbness and tingling was recovered with sequelae at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At 3:52 Pt sat down and said he felt a little dizzy and has a little headache-ordered pt to drink 2 bottles of water, applied cold compress pack and he felt better. At 4:00pm, pt c/o that he felt headache and dizzy again-applied cold  compress pack, checked vitals:220/149, HR-100, R-20,per pt, baseline is 140/90, P-61, but pt also gave history that he gets nervous with any shots/vaccines/seeing doctor. Monitored pt for additional 15 minutes and pt said he felt better, reassed VS: 182/62, P-94, O2 stat-98%, R-20, cleared and was picked up by girlfriend.
This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 19-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # 1003855, expiration date 05-FEB-2017) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Reported Symptoms: swelling around injection site, itchiness,  01/08 lymph node in armpit swollen and painful Date of Onset: 1/1/2021 injection site swelling; 01/08/2021 lymph node swelling;  01/11 larger raised area at injection site, itchy through 01/15/2021
fatigue, light headedness, low grade fever of 99.0, nausea, "foggy" headed, dizzy
I am infected with vocal 3 days ago; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTION (non-serious) with onset 2021, outcome "unknown", described as "I am infected with vocal 3 days ago"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Sick".  No follow-up attempts are possible. No further information is expected.
Pt devel a fever of 105 approx 1 1/2 hrs post vax;  APAP given every 4 hrs; sponge bath given as needed; fever lasted for @ least 12 hrs; pt was afebrile the next day;
Hives beginning on buttocks and spreading to elbows during 11/07/2015.  Intense burning and itching at site.  Hives spread to forearms backs of thighs, knees, and calves on 11/08/2015.  On 11/09/2015 hives spread to wrists, neck, below left eye, behind ears, ankles, top of right foot, knuckles of both hands causing redness, swelling, and difficulty bending digits.  On 11/09/2015 saw my OB who recommended 50 mg of Benadryl at bedtime.  Benadryl has lessened the burning/itching sensation for several yore after being taken, but the swollen welts remain, and itching is never completely relieved and returns at full force a few hours after Benadryl is administered.
?Janssen COVID-19 Vaccine EUA? - Right after I received the shot I initially had a wave of dizziness, which passed after 15-20 min. so I left and went back to work.  Since I received the shot I've had dizzy spells daily.  It happens all throughout the day and typically lasts for 15 minutes to an hour each time, multiple times a day.  I contacted the pharmacy at the Health Services on 4-9-21 to ask if they had heard of anyone else having dizziness like I'm having and they said no.  Told me I could take over the counter Meclizine to help with the dizziness and suggested I check in with my PCP - I have an appointment scheduled May 5th, so I planned on waiting until then unless it becomes worse.
Immediate arm pain and muscle cramping around left side of body specifically the diaphragm. Twelve hours past vaccination: Chills, Extreme Body Aches, Muscle Pain, Chest Pain, Shortness of Breath, Headache, Dizziness, Nausea, Extreme Fatigue, Burning Hot but no registered fever.
10/23/12 2:40pm Pt. c/o dizziness, cheeks flushed and c/o stomach "hurt" - states he vomited (not witnessed). Layed down on cot at school and flushing improved and stated stomach was better. Talked with mom today 10/25/12 and he is "fine" did feel "tired" the evening of flu shot. Mom states he is ok today (10/25/12).
pain at the injection site; Intercepted drug administration error; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and intercepted drug administration error. On an unknown date, the outcome of the injection site pain and intercepted drug administration error were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vacination was not provided. The age group of the patient was not reported but selected as an adult as per vaccine indication The , patient received 1st dose of Shingrix and experienced injection site pain. The reporter reported that, after vaccination with 1st dose, the nurse asked to return for 2nd dose in 1 month. The patient would called to doctor office and reschedule for at least two months for 2nd dose of Shingrix, which led to intercepted drug administration error.
patient came into the pharmacy stating that he had gotten his vaccine on 7/15/19, and he was experiencing some head aches that were on an off. Tylenol seemed to help. I examined the injection side and it appeared to be normal with no signs of redness or swelling. He also mentioned that his heart started racing when he went home after getting the vaccine. Since he had a cardiologist appointment 2 days ago he brought up the concern. His cardiologist did and EKG, found nothing to worry about. He continued to mention about the head aches that come and go. I advised patient to f/u with pcp if his head aches did not improve. I also went over the side effect of shingrix with him.
Suddden onset of feeling very hot in my face and neck..  I went to bathroom and looked at my face  no swelling noted. My neck had a pouch  of fluid accumulating with small redden areas on my neck and upper chest area.  No other symptoms noted. My breathing was good.
unable to hold down any food; severe nausea; vomitting; lost 25 pounds since then; feels very weak; dealing with GI periodically since then; unable to hold down any food; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then) and ASTHENIA (feels very weak) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then), ASTHENIA (feels very weak), GASTROINTESTINAL TRACT IRRITATION (dealing with GI periodically since then) and FEEDING DISORDER (unable to hold down any food). At the time of the report, DIARRHOEA (unable to hold down any food), NAUSEA (severe nausea), VOMITING (vomitting), WEIGHT DECREASED (lost 25 pounds since then), ASTHENIA (feels very weak), GASTROINTESTINAL TRACT IRRITATION (dealing with GI periodically since then) and FEEDING DISORDER (unable to hold down any food) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment included Phenergan and Zofran.
On the night of vaccine administration, the pt developed erythema on the left upper extremity. No fever noted. Ice compress was applied to the area.
pt recv vax 5MAR98 & 1APR98 lab eval revealed that pt had transient hep B-Ag positivity;f/u info from MD reported tha transient hep B-Ag positivity wa snot verified on repeat;
This spontaneous report was received from a male patient concerning himself of unknown age (age reported as 76 (units unknown). On 28-APR-2014 the patient was vaccinated with ZOSTAVAX 1 time vaccine, in the left arm (route and dose unspecified). Concomitant therapies included LIPITOR. On 29-APR-2014, the patient experienced pain at site of insertion after getting ZOSTAVAX vaccine, in his left arm. On 02-MAY-2014 the patient started getting an intermittent pain in his back. He described this was painful to the touch, which has not gone away. There was no product quality complaint (PQC) involved. Patient sought no medical attention. The outcome of pain at site of insertion after getting ZOSTAVAX was unknown. The outcome of started getting an intermittent pain in his back was reported as not resolved. Causality assessment was not provided. Additional information has been requested.
Vaccine was at approximately 2:45 p.m.  Around midnight that night I developed cold chills and a headache.  Symptoms are persisting as of 1:00 p.m. on 12/23/21.
stroke 8 days after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke 8 days after booster shot) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke 8 days after booster shot) (seriousness criteria medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke 8 days after booster shot) outcome was unknown.            No concomitant medications provided. No treatment medications provided.  A consumer calling to report that their mother had an stroke 8 days after receiving the Moderna booster shot.  Company Comment : This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Cerebrovascular accident. The event occurred on an unknown date after the third dose of mRNA-1273 Vaccine which resulted in a Life threatening situation and Hospitalization. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Cerebrovascular accident. The event occurred on an unknown date after the third dose of mRNA-1273 Vaccine which resulted in a Life threatening situation and Hospitalization. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender who on unspecified dates 2 years ago "in 2010" was vaccinated with the first and second dose of GARDASIL (dose, route and lot numbers not reported). On 11-SEP-2012, the patient was in the office to receive the third dose of GARDASIL (dose, route and lot # not reported). No adverse effects were reported. Additional information is not expected.
2 pts recvd 3 doses of Engerix-B vax 21JAN91, 25FEB91 & 21AUG91 & it was determined that the pt did not respond to the vax series; A 4th dose of Engerix-B was given 15OCT91 & again it was determined that pt did not respond;
Case number PHEH2014US024280, is an initial spontaneous report received from a nurse on 02DEC2014, with a follow up received from nurse on 21JAN2015. This report refers to a 52 year old female patient. Medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 14511P, expiry date: MAR2015) intramuscularly into the left deltoid at a dose of 0.5 ml on 24NOV2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. The patient did not experience any adverse reaction due to the maladministration (incorrect storage of drug). No further information was provided. Follow up received from nurse on 21JAN2015: Updated site of vaccination and reporter comment.
Received vaccine on 1/6, mild fever/achiness on 1/7.  On 1/8 had some chest pain and SOB.  This continued to get worse on Friday.  By Saturday, patient felt she could not get comfortable and was more short of breath.  She went to the ER and after multiple tests they found multiple pulmonary emboli.  Of note, patient took a long flight on 1/6 and is on hormone replacement therapy.
death Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 03/08/2021. Patient died 03/09/2021. Medical examiner received report that patient was alert before a fall on the night of 03/08/2021. Death certificate will report death likely due to arrhythmia due to underlying CHF. Contributing factors include diabetes.
This is a serious spontaneous case from a physician in the USA involving asthma. The reporter causality is not related to FluMist. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. This is a spontaneous case report sent by a physician that refers to a female aged 10 years. The patient's past medical history included pneumonia in October 2003 and in the year 2002. She received FluMist on 12/10/03, the lot number and vaccine administrator were not recorded. On 1/19/04, the patient experienced fever, persistent cough, and shortness of breath. She was brought to the emergency department where she was reported to have decreased oxygen saturation. She was admitted to the hospital with a diagnosis of right lower lobe pneumonia confirmed by chest x-ray and asthma. Structural abnormality/reactive airway disease, and cystic fibrosis were ruled out. Triple IV antibiotics were administered and was placed on oxygen supplement via face mask for several days. During this hospitalization, the patient had episodes of oxygen saturation below 90% while sleeping. The patient has not been diagnosed with asthma before this event. The reporter felt neither pneumonia or asthma were related to FluMist, although he did consider the possibility. The patient has recovered but continues on a daily steroid inhaler and salbutamol as needed.
Per Walk In Clinic's notes: Patient 89 year old female presents today to clinic with complaints of    #Vaccine reaction - Located on right upper arm - Received shingles vaccine on 21 July 2021 and notes symptoms started a few hours later - Now has redness, painful lump and area warm to touch - Denies shortness of breath, chest tightness  Assessment and Plan: (T50.Z95A) Vaccine reaction, initial encounter  (primary encounter diagnosis) Plan:  - Discussed symptoms are a reaction to recent shingles vaccine - Outlined area of concern for monitoring - Recommend supportive home care; OTC Tylenol not to exceed 3,000mg/24 hours and cold compresses to the area - Will have clinic RN submit VAERS report - Follow-up with PCP as needed for concerns     Return precautions given for fever, chills, chest pain/tightness, shortness of breath, palpitations, abdominal pain, nausea/vomiting, numbness/tingling/weakness in extremities, symptoms that worsen or don't improve with treatment plan
Developed ringing in ears (tinnitus) 4 days after receiving the Moderna Vaccine - Shot #1
Today August 10, 2021 at 11:15am patient came in for her scheduled second dose of COVID-19 vaccine appointment which was originally scheduled at 4:50 pm under COVID Clinic. Patient came in to clinic front desk receptonist asking if Lab Supervisor can administer vaccine as she was comfortable with her giving it and has in the past received vaccines. Lab Supervisor then informed RN in regards to patients request and verbally gave RN patients information which moments later RN came with drawn vaccine which was Pfizer. Patient had received first dose of Moderna back in 7/13/21 and was to be scheduled for a second dose of Moderna.