chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health care professional via a company representative and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date (reported as "recently"), the patient was vaccinated with GARDASIL 9, 0.5 ml, once for prophylaxis (route of administration, dose #, lot # and expiration date were not provided). On unspecified date, the patient and had a raised red bump the size of a quarter at the injection site and that it was painful. The outcome of the events was not reported. The causality between the events and the GARDASIL 9 was not provided.
Several hours after flu shot, began to have severe coughing and itching, rash.  Then tongue became swollen.  Went to doctor who ordered antihistamine, aderol, flonaise, prednisone.  Several hours later had chills, fever of 100.7 and nausea.  Next day symptoms improved but also had swelling under eyes causing dark circles and itchiness.
Pt received flu shot at renal clinic and developed tremors 5 min after flu shot. BG 211. Pt denied neurologic disorders. Was sent to ED for monitoring. Symptoms dissipated after 2 hours. Discharged home with follow up in 2-4 days.
Narrative:  Immediately after receiving the Covid Injection, pt report he felt like he was going to pass out" . CODE BLUE called to vaccine clinic. Patient was sitting in the chair pale and diaphoretic. Patient stated he felt like he was going to " pass out" prior to receiving his first COVID vaccine shot and informed the staff. After being transported to Urgent Care pt's color returned, and non-diaphoretic. Pt remain with tingling sensation to upper extremities. Per MD monitored pt without any interventions. Reassurance provided along with coaching of breathing. After about an hour and half, pt reports he is ready to go home. Tingling sensations resolved. Patient was discharged.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 14:00 (Lot number: ER8730) at the age of 71 years as dose 2, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FINASTERIDE; ATORVASTATIN; METOPROLOL; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose 1, single Lot number: EL9266, arm left, Time: 14:00), administration date: 27Feb2021, for COVID-19 immunization. The following information was reported: APHTHOUS ULCER (non-serious), ACNE (non-serious) all with onset 01Oct2021 12:00, outcome "not recovered" and all described as "Canker sores continual since October 2021. Pimples on scalp Oct, Nov, Dec2021. Curious if these are related to vaccine". The event "canker sores continual since October 2021. pimples on scalp oct, Nov, Dec2021. Curious if these are related to vaccine" and "canker sores continual since October 2021. pimples on scalp Oct, Nov, Dec2021. Curious if these are related to vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of aphthous ulcer, acne. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The reporter considered the events as non-serious. Hospitalization prolonged was reported as no. Follow-up attempts are completed. No further information is expected.
vaccination from a facility five days after the expiration of the vial; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and EXPIRED PRODUCT ADMINISTERED (vaccination from a facility five days after the expiration of the vial) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and LOVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccination from a facility five days after the expiration of the vial). At the time of the report, PAIN IN EXTREMITY (Sore arm) and EXPIRED PRODUCT ADMINISTERED (vaccination from a facility five days after the expiration of the vial) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
With first dose (03/04/2021; lot#029A21A) only sore arm. With second dose (03/29/2021) tired, a little dizziness, a little nausea day of vaccine and slight fever (100.1 highest) in morning of the next day. Fully recovered within 26 hours after 2nd vaccine dose. SIX months later, developed shingles: pain started 09/24/2021, noticed rash and went to urgent care where diagnosed with shingles 09/26/2021. (I had planned on getting the shingles vaccine soon, but didn't get a chance before getting shingles.) I received the V-safe 6-month followup text 09/27/2021. I reported shingles. They said to report to VAERS. I still have a rash and am still recovering from Shingles (10/05/2021).
Tdap (ADACEL) given on 6/12/14. 4 hours later patient experienced rash and swollen tongue. Issue resolved with 1 dose of BENADRYL, patient took herself.
This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (after the first dose she had insomnia and a headache for that day and the next day) and HEADACHE (after the first dose she had insomnia and a headache for that day and the next day) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Previously administered products included for Product used for unknown indication: FLUZONE (flu shot 14 days before taking the booster). Past adverse reactions to the above products included No adverse event with FLUZONE. Concurrent medical conditions included Pollen allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INSOMNIA (after the first dose she had insomnia and a headache for that day and the next day.) and HEADACHE (after the first dose she had insomnia and a headache for that day and the next day). At the time of the report, INSOMNIA (after the first dose she had insomnia and a headache for that day and the next day) and HEADACHE (after the first dose she had insomnia and a headache for that day and the next day) had resolved. 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. Patient Concomitant medication reported as blood pressure medicine. No treatment information was provided by the reporter. This case was linked to MOD-2022-533591 (Patient Link).
Tenderness at injection site. Below the injection site, area was red and warm and itchy. PA recommended CLARITIN and hydrocortisone cream.
Extreme hip and knee, joints pain and stiffness. Pain 9 out of 10 difficulty walking. Could climb stairs one at a time pulling myself up. Left foot first one step at a time.
Information has been received from a consumer concerning her 18 year old daughter with a history of unspecified allergies, who on 02-JAN-2007 was vaccinated with Varivax (Merck), and subsequently, on 03-JAN-2007, developed fever, diarrhea and nausea. Concomitant therapy included fexofenadine hydrochloride (ALLEGRA). The patient's fever and diarrhea and nausea persisted, and were not recovered at the time of this report. Lab diagnostic studies were not performed. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Flu like symptoms, throat and neck pain, back pain, rash on lower face on third day
fully vaccinated with Pfizer x 2. Tested positive for Covid on 01/25/2022. Admitted to Medical Center, on 01/25/2022. Expired on 02/19/2022 while still hospitalized.
My longstanding tinnitus worsened noticeably since I received my booster shot. I have also noticed that my hearing has worsened.  I was not anticipating any sort of side effects so I didn?t note when the changes occurred.
She knows that it is Shingles; Soreness at the injection site; Developed a lesion on skin; Lesions are painful; Lesions burn; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received vaccine on an unknown date).   On 23rd September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced shingles, injection site pain, skin lesion, pain and burning sensation. On an unknown date, the outcome of the shingles and skin lesion were not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the pain and burning sensation were unknown.   It was unknown if the reporter considered the shingles, injection site pain, skin lesion, pain and burning sensation to be related to Shingrix.  Additional details were received as follows: The patient received the 1st dose of Shingrix and experienced soreness at the injection site. The patient also developed lesion on her skin, the lesions were painful and burn and patient knew that it was Shingles because she has had Shingles in the past. The patient consented to follow up.
Pt developed hives and itching of trunk, arms and neck. She then developed swelling of the left lip and eye. No airway distress.
15 month old infant presented to office on 1/4/22 for well-visit.  MD ordered Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB), and DTaP vaccine less than 7yo IM (INFANRIX) to be given during visit. CMA prepared and administered the following immunizations:  Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) IM to patient's LVL (LOT # EM2364), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) IM to patient's RVL (LOT # U013278), and DTaP vaccine less than 7yo IM (INFANRIX) IM to patient's LVL (LOT # 7EC55). On 1/8, parent sent message to office noting "huge lump on patient's left thigh".  Lump was non-tender and didn't seem to bother patient. Patient returned to office on 1/11 for fluoride treatment.  MD noted "1 cm diameter nodule in right thigh from vaccine injection site, no redness, overlying swelling, no drainage" on 1/11.  Patient had been afebrile. System lists local injections site reaction including "Pain at injection site, erythema at injection site, swelling at injection site, tenderness at injection site".
On 9/17/20, the patient presented with a very red and warm to the touch arm.
I didn't initially tie things together but wanted to report this in case it is related to the vaccine. Shortly after receiving the vaccine I started having back problems. I was unable to identify any event that would have caused them. The symptoms first appeared a week or 2 after my first vaccine and worsened a week or 2 after my 2nd. I continue to have back pain and have been paying attention more and have noticed that I have additional joint pain.
Within 28 days of the MMR, Varicella and Polio vaccines, my son developed a swollen groin gland (inguinal) and then a week long rash that recycled all over his body.  Then he got a fever of 102 degrees for four days, during which time, his cervical gland swelled and the skin around his eye swelled.  There was some green pus for a short time. once the fever broke, he got hives for three days.  In that time he was tested for EBV, Lyme Disease with a Western Blot, ANA, Sed rate and two CBCs.  His blood work all showed normal results, but his glands have continued to stay swollen 6 months later now!  I had to pay a deductible for all of these tests and still nothing has been determined!  I still don't know if anything else will now develop as a result of this.  the swollen glands are an indication though, that the body is still trying fight something, for 6 continuous months!
Patient complained of burning sensation down the arm (left) the shot was given yesterday. Today it looks raised and patient complains of irritation. They were consulted to put ice on the area and take BENADRYL.
Swollen lips and a extreme soreness of the skin on the inner lips. Areas of the inner lip skin seemed to blister as if burned and sloughed off. No, I have never had lip fillers, botox or other lip injections. My care provider prescribed a 6 day steroid pack. The swelling stopped  and reversed shortly after the first dose was taken. My inner lip skin healed and was normal after 5 days. I would like to know if your recommendation as to whether I should get the second shot or not? I'm sure I could get the steroid pack in advance in case I have a similar reaction to the second shot.
heart palpitations; she feels like a bumble bee on crack; some chest tightness; heart racing; very hipper as if she used a inhaler and steroids; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), FEELING ABNORMAL (she feels like a bumble bee on crack), CHEST DISCOMFORT (some chest tightness), PALPITATIONS (heart racing) and FEELING ABNORMAL (very hipper as if she used a inhaler and steroids) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PALPITATIONS (heart palpitations), FEELING ABNORMAL (she feels like a bumble bee on crack), CHEST DISCOMFORT (some chest tightness), PALPITATIONS (heart racing) and FEELING ABNORMAL (very hipper as if she used a inhaler and steroids). At the time of the report, PALPITATIONS (heart palpitations), FEELING ABNORMAL (she feels like a bumble bee on crack), CHEST DISCOMFORT (some chest tightness), PALPITATIONS (heart racing) and FEELING ABNORMAL (very hipper as if she used a inhaler and steroids) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported
patient had rash and swelling starting day after vaccination; patient had rash and swelling starting day after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "patient had rash and swelling starting day after vaccination".  Additional information: Reported Event: patient had rash and swelling starting day after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
local rxn to DPT lt deltoid IM; no fever 2 1/2" to 3" circumference red, warm to touch & tender;
Myalgia, Fever, fatigue; abdominal pain and bloating Narrative:  Employee reports, "I received my first dose of the vaccine (from work) on 12/31/2020. I had about 24 hours of aches and pains, but then felt better. On 1/12 and 1/13 I then had what felt like an autoimmune flare (I have a history of Crohn's Disease). Body aches, extreme fatigue, and abdominal pain & bloating. Very slight elevation of temp, nothing too severe, but not typical of my condition in the past 10 years (I've been in remission). 1/14 back to normal.
I received the first dose 1/9/21 and the second dose 1/29/21.   I stopped taking BC pill (YAZ) in Dec. 2021. I started having abnormal vaginal bleeding in April 2021. I  was seen by GYN. In April I had a vaginal US that was negative for CA, no masses. I had spotting April, July, and August of 2021. I August I had endometrial BX that was negative. I was advised to restart YAZ which I restarted on 9/2/2021. On 9/2/2021 I started to have heavy bleeding (more than just spotting) with clots. I have bleeding the entire month of Sept/Oct 2021. Finally, in November of 2021 the bleeding stopped and I continued with BC (Yaz).  I received the booster on 12/18/2021 Walk in.  On 12/31/2021 I started to have spotting again which has lasted 30 days. I reported the bleeding this time on the v-safe check in app. I received a call from CDC advising to report the bleeding to VAERS. She advised me that the bleeding was a new symptom since the vaccine and I should report .  I have followed back up with my GYN and have a repeat vaginal US scheduled to next week. I will also have a D&C if the bleeding continues. I was given a higher dose BC to try. I will try to start it next week.  Below are the first two vaccines which I received. 1/9/2021 Lot #EL1284 1/29/2021 Lot #EL 3248
I developed shingles rash and pain in the left thigh and hip. I was prescribed acyclovir for 10 days. During this time I also had lip swelling and needed to be prescribed benadryl and predisone. I was not getting better so my husband took me to the hospital ER on June 20, 2021. I was admitted with concern over a delayed and continual reaction to the vaccine.
Vomited x 2 today, dizziness x 2 since yesterday, chills, loss of appetite, headache x 1 day, loose stool x 1 today. Patient has been drinking water.
Redness/warmth left deltoid. Some itching. Local allergic reaction vs. cellulitis. Placed on Keflex for conservative management.
Within a few minutes of receiving the flu vaccine (mandatory by facility) I began to feel dizzy, lightheaded, extremely dry mouth, throat felt like it was tightening up, short of breath, and heart beating fast. I also was itching and had a rash all over. I was immediately taken to the emergency room. My blood pressure was elevated 150/104, heart rate 118, oxygen sat 100% on room air. I was given IV fluids, steroid, ZANTAC, and an antihistamine while in the ED. I developed chills as well. I was discharged home on steroids and BENADRYL. I had to follow up at facility due to being work related.  I continued to have breathing problems for at least 2 to 3 weeks after reaction.
Injection site red and swollen.  Pain in the injection arm, diarrhea, fever, stomach malaise and patient's primary care doctor indicates that patient developed a cellulitis.
Patient was given 3-year old Flu dose (0.5mL) instead of 6-35 month (0.25 mL) Flu dose for 2nd due Flu shot. Parent was informed immediately by phone after patient left. No adverse symptoms occurred with patient in the clinic.
dose of ROTATAX 02/14/2022, On 4/22/2022 they administered Rotarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number L4NH3, expiry date 23rd July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE (ROTATEQ) for prophylaxis.   On 22nd April 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 14th February 2022, the patient received ROTATEQ. On 22nd April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-AUG-2022 Reporter's comments: The reporter reported that, a patient was vaccinated with a dose of Rotateq on 14th February 2022.  The patient was then administered with the Rotarix and second dose was not administered yet. The reporter did not consent to follow-up. Additional Supportive Information: As patient first received Rotateq followed by Rotarix, which led to Interchange of vaccine products. Note: As the discrepancy in vaccine name Rotatax, the Rotatax was considered Rotateq conservatively.
Patient not eligible for Janssen based on age.  RN vaccinated not knowing age restrictions.
Pt developed a "fever" at 14:00 and a rash on her arms and legs in the evening. Mom took her to ER. On 5/2/00, her temperature was 101 and she was given Benadryl to take until rash susided. Was instructed to PP give any further vaccines as they believe pt has allergic reaction to a vaccine. Rash subsided on 5/4/00. States daughter is ok now, 5/9/00.
This spontaneous report as received from a registered nurse via a company representative refers to 2 patients of unknown age (siblings). No pertinent medical history or drug reactions/allergies were provided. On 21-JAN-1999, the patients were vaccinated with their first dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided). On 24-FEB-1999, the patient were vaccinated with their second dose of RECOMBIVAX HB 5 MCG/0.5ML (route and lot number not provided). No co-suspect or concomitant therapies were reported. The nurse reported that, on an unknown date in 2005, both patients had negative (not immune) hepatitis b titers, and on 10-MAY-2013, the patients received their dose of RECOMBIVAX HB 5 MCG/0.5ML, lot # H017304, expiration date 11-JUN-2015 (route not provided). At the time of the report, the outcome for the event "Both patients had negative (not immune) hepatitis B titers" was unknown. Additional information has been requested.
Have a scratchy voice; I experience the swelling of my eyes; They became bloodshot; Felt incredibly irritated; Have a scratchy voice; They burned along the lash line.; I had an incredibly stuffy and runny nose; Runny nose; I now feel like feverish; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration, administered in right arm on 26Mar2021 at 16:45 (at the age of 22 years) as dose 1, single for covid-19 immunization. Medical history included irritable bowel syndrome, acid reflux. The patient's concomitant medications were not reported. The patient previously took witch hazel and experienced allergy. Patient had no other vaccine in four weeks. The patient did not test COVID-19 positive prior to vaccination. On 27Mar2021, at 02:30, the patient experienced the swelling of her eyes. They became bloodshot and felt incredibly irritated and they burned along the lash line. it hurt to close her eyes and she had an incredibly stuffy and runny nose then she felt like feverish and had a scratchy voice and her eyes were still swollen. The patient received for the events scratchy voice, ocular hyperemia, swelling of eyelid, eye irritation, and rhinorrhea with Benadryl and flush her eyes and did a compare. The patient was not tested for COVID-19 since the vaccination. The outcome the events was unknown.  Information about Lot and batch number requested.