chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash, red, raised w/ small lesions; Back is quite itchy; small lesions; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced red rash, pruritus and skin lesion. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the red rash, pruritus and skin lesion were unknown.   It was unknown if the reporter considered the red rash, pruritus and skin lesion to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the shingles vaccine and about a week later he/she developed a rash (red,raised with small lesions).  The right side of back in a strip quite itchy.  The patient applied Hydrocortisone cream which helped some.  The reporter wanted to know could you get the virus 7-8 days later. Additional Supportive Information: The follow up would not possible as no contact details were available.
The injection site was red for a while; Her arm hurt a little (L arm); Arm is swollen (L arm); Her armpits and the right arm began to hurt; Headache; Cold (chills); General tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt a little (L arm)), PERIPHERAL SWELLING (Arm is swollen (L arm)), AXILLARY PAIN (Her armpits and the right arm began to hurt), HEADACHE (Headache) and CHILLS (Cold (chills)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE (General tiredness). On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt a little (L arm)), PERIPHERAL SWELLING (Arm is swollen (L arm)), AXILLARY PAIN (Her armpits and the right arm began to hurt), HEADACHE (Headache) and CHILLS (Cold (chills)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (The injection site was red for a while). At the time of the report, PAIN IN EXTREMITY (Her arm hurt a little (L arm)), PERIPHERAL SWELLING (Arm is swollen (L arm)), AXILLARY PAIN (Her armpits and the right arm began to hurt), HEADACHE (Headache), CHILLS (Cold (chills)), FATIGUE (General tiredness) and VACCINATION SITE ERYTHEMA (The injection site was red for a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Muscle pain - "felt like I had glass in my muscles" which lasted for 48 hours.  Joint pain to bilateral shoulders and hips which has been ongoing for >2 months.  I now have an orthopedic referral pending. I have a history of arthritis and joint pain but the pain was significantly exacerbated immediately after (within 24 hours of) the 2nd vaccine dose and has become debilitating.
Pt brought by father was brought in this morning to catch up on vaccines due to parents delaying immunizations. Patient came in to receive DTAP, MMRV, and HIB I prepared vaccines and noticed after vaccines where given, when inputting in system I made a mistake. I informed my office manager, Father and Dr. as well. I contacted Human and resource to inform and to get advice on what next step I needed to follow. Dr. spoke with parent as well. I monitored patient and there was no reaction to the extra DTap vaccine given. Patient left with parent and I also contacted Mother to inform of the mistake.
Palpitations off & on over period over about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations off & on over period over about 5 days) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A, 051F21A and 02Apr2021) for COVID-19 vaccination.     The patient's past medical history included Cardiac catheterization (6-7 yrs ago. Dx: Stress-related).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PALPITATIONS (Palpitations off & on over period over about 5 days). At the time of the report, PALPITATIONS (Palpitations off & on over period over about 5 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-385842, MOD-2021-386519 (Patient Link).
She is just not feeling well; flare up of her environmental allergies (sneezing, itchy, watery eyes.); Sneezing; coughing; congestion; itchy; watery eyes; headache; fatigue/She sleeps 10 hours every night and she does not feel rested; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN5318) via an unspecified route of administration in left arm on 02Feb2021 (at the age of 45-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history included seasonal allergy, allergic conjunctivitis, environmental allergies. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced very intense flare with sneezing, coughing, congestion, itchy, watery eyes. Patient reported that she remembers she took it that evening. she got it through her job and she was able to go after work and immediately she felt fatigue on 02Feb2021. She was  sleeping that whole night and that has continued she has had the same level of fatigue since then. She sleeps 10 hours every night and she does not feel rested. She had headache that started the next morning wednesday on 03Feb2021. It's like headache, head pressure and she know that's expected and she would say it's been the same level of intensity until about saturday or sunday slowly getting less but it's still there. She had a question of duration and is this normal symptoms and how long they last and the agent said she doesn't have the information for the first dose. She has seasonal allergies, environmental allergies and she had a break for a couple weeks and did not have any kind of flare, they were under control with medications then thursday. She started having a very intense flare sneezing, coughing, congestion, itchy, watery eyes, things she would normally take meds for, the meds are not working. She takes over the counter or prescribed meds she has still been taking them but she is flared up more than usual these past few days. She names of medications, she can check know the Allegra. It was reported that patient spoken 2 different people but she was calling reporting some of side effects that were listed but then she have had some questions about duration of some of them after the first dose. She have had other symptoms that were not listed on the list and she was wondering if there were connections to the vaccine. She was just not feeling well, she did called her doctor but saw the number on the fact sheet and she wanted to called pfizer as well. Patient took medications such as flonase for her nose and the lot number is AB1350A expiration May2022, Allerfex for her eyes lot number is 0FR0350 and expiration Jan2022. The new eye drop she has been on for 2 weeks is Ellistat, the eye drop lot number F0904 and expiration Sep2021. The outcome of the events headache was recovering, fatigue was not recovered and other events was unknown.  Follow-up attempts are completed. No further information is expected.
patient received a higher dose for the second vaccine of COVID; dose administered was a higher dose.; The patient's were administered with LOT# FK9729; Fever; pain in the point of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 8 year-old male patient received BNT162b2 (BNT162B2), administered in arm left, administration date 11Feb2022 (Lot number: FK9729) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 11Feb2022, outcome "unknown", described as "children received a higher dose for the second vaccine of COVID; dose administered was a higher dose."; PYREXIA (non-serious) with onset Feb2022, outcome "unknown", described as "Fever"; VACCINATION SITE PAIN (non-serious) with onset Feb2022, outcome "unknown", described as "pain in the point of injection"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Feb2022, outcome "unknown", described as "The patients were administered with LOT# FK9729". Therapeutic measures were taken as a result of pyrexia, vaccination site pain.  Additional Information: It was reported as "One of my friends reported to me that his patient received a higher dose for the second vaccine of COVID and that they are experiencing fever and pain in the point of injection. The second dose, the dosage that was wrong. Patients, 8 and 10, the dose administered was a higher dose." This is the case for 8 year old child.  They are both taking only children's Tylenol (Clarified taken as Treatment) at this time (Intent: Treatment), Tylenol for patients. They are taking it for discomfort. They are not on any kind of therapy or medication. The patient did not have any prior vaccination within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Patient with hx of multiple medical problems lung cancer on chemo, colon and renal cancer, obesity , COPD, former smoker and Oxygen dependent was recently discharged from hospital d/t Covid-19 infection, presented back to ED on 10/07/2021 with confusion, tremors, and found to be in acute renal failure, severely dehydrated and was uremic.  Patient was admitted to ICU.  CT scan revealed cavitary lung lesion on right lower lobe, known to be squamous cell CA.  On 10/18/2021, patient remained minimally responsive, comfort measures in place.  Patient expired on 10/18/2021.
Severe lymphadenopathy on both sides; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 07Apr2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 08Apr2021, the patient experienced severe lymphadenopathy on both sides that had lasted 2 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe lymphadenopathy on both sides was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
he suffered a mini stroke 2 weeks after; congenital hole in his heart between the atrium; in which 2 days later he got the Covid virus; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 42-years old male patient (husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date in Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The pharmacist reported that on an unspecified date in Mar2021, two days after vaccination, the patient got the Covid virus due to an unknowing prior exposure and that once he got over the Covid virus. On 04Apr2021, he suffered a mini stroke two weeks after receiving the vaccine. She stated that while her husband was in the hospital, they found a congenital hole in his heart between the atrium which was the reason why he had a mini stroke. Her husband is scheduled to receive his second dose the next day and asked for any guidance on whether he should receive the vaccine at that time. She stated that she had spoken with his cardiologist, in which they believe it is best to hold off until after surgery to receive the second dose, just in case. Outcome was unknown for all the events.  Information on the lot/batch number has been requested.; Sender's Comments: Based on current information available, the event stroke and congenital atrial septal defect represented intercurrent condition in this patient unrelated to Bnt162b2. Covid19 was considered related. However, full immunity is only expected 1 week after the second dose.   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 RAs, Ethics Committees, and Investigators, as appropriate
Diagnosed with Shingles-  symptoms (tendernous and rash) began two days after 2nd Covid vaccination.
Since 10 days I have heavy dizziness, vertigo, blurred vision (not all the time) and chills (not anymore last 2 days). The first 5 days I had also low fever. I still don't have appetite. I am drinking a lot of water and taking vitamin C and D.
Started to itch with hives on 1/29 on thigh. within three days hives covered 60 -70% of my body. All around the thighs rear end, arms, chest, back , hands, head ,neck including my ears and face.  Horrible itch.  On 2/1/21 Dr.s office gave me a Cortisone shot, and a Benadryl shot to calm the itch , also Triminolonie Acetonide Cream 0.1%. Not much help after two hours of receiving these. On 2/4/21 Prednisone 20mg tablets  for 7 days was ordered for me. This began to finally work. On 2/11/21  I'm greatly improved.
Information has been received from a published article, title as stated above. This literature case was initially reported to foreign health agency on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient # 30 of 32, a 28 year old female. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccine in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 28 year old female on an unspecified date was vaccinated with the first dose of RECOMBIVAX HB (lot number, route and site not reported). Concomitant therapy included typhoid vaccine (unspecified). One day after vaccination, the patient developed uveitis. On an unspecified date the patient experienced meningitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of headaches and lymphadenopathy. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 TO WAES 1004USA02354, WAES # 1004USA02356 TO WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
We waited 20 minutes after vaccine was given and no reaction.  About 40-45 minutes later he began coughing a tremendous amount and his skin took on a bright red color that looked like he was sunburned.  His lips and ears swelled and he developed hives.  He was able to breathe but said he felt like he wasn't getting enough oxygen.  All the symptoms happened within minutes wiht the cough starting first.  We took him immediately to the ER.  They gave him an Epi shot, Benadryl, Zantac, Solumedrol (steroid), and a nebulizer treatment.  They monitored him for 5-6 hours.  He recovered nicely. They sent him home with prescriptions for Epi Pens, steroids, Benadryl and Zantac.  His discharge sheets diagnosis said allergic reaction to vaccines.  The ER doctor said he had an anaphylactic response.
Positive for COVID - home test 9/11/2022. Physician confirmed 9/12/2022.
Varicella - Information has been received from a healthcare proessional concerning a 25 month old male who on 19 Feb 1999 was vaccinated with one dose of varicella virus vaccine live (site unknown).  On 07 Apr 2000 the patient developed chicken pox with 20-25 lesions.  The patient sought unspecified medical attention.
We didn't notice child is under 5 yrs old and we gave the Covid 5-11yrs Pfizer Vaccine. He had no symptoms after administration of vaccine. Dr. spoke with patients guardian. Dr followed up with them on 8/2/22 still has no symptoms.
I woke up at 4:30am to shower.   Once in the shower I got lightheaded, yelled for my husband, and as he was getting there I fainted in the shower.   I came to, rested a second but when he helped me up I fainted a second time.   Laid in bed for several hours.   Took blood pressure/heart rate around noon and heart rate was 115.
Patient was given Rotavirus at her 9 month visit instead of her 6 month visit. Provider was informed; checked with parent and the patient and they both were fine.
Vaccine given 11/25/11, 11/26/11 swelling eye lids O.U., throat scratchy, dry. Eyelid edema persisted 11/27, 11/28/11. Rash 11/29/11 face, chest, back.
Patient had a vasovagal reaction and fainted after the vaccine. He fell sideways out of the chair and hit his head.
Nausea, sick feeling - sudden onset - patient remained seated and drank water and recovered, pt. has been getting the flu shot before, no problems reported last year.
One week after injection; Left arm swollen, rash, extreme arm pain and arm felt as if it was burning.  Entire body was itching, developed sore throat, headache, fatigue, night sweats and chills for approximately 48 hours.
Hurts a lot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   The reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-DEC-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received the first dose of shingles vaccine and its hurts a lot. The patent also stated that it's worth it.
Teeth clenching; Persistent dental pain; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 30Mar2021, (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy, hand osteoarthritis and overweight. The patient had no known sllergies to medications, food or other products. Concomitant medications included pseudoephedrine hydrochloride (SUDAFED), guaifenesin (MUCINEX), salbutamol (ALBUTEROL), butalbital, caffeine, paracetamol (FIORICET) and hydrocodone bitartrate, paracetamol (VICODIN) all from unknown date, for unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in right arm on 09Mar2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 the patient experienced fever, chills as expected, but accompanied by (apparent) teeth clenching, resulting in random but persistent dental pain in both upper and lower teeth continuing till this reporting. (The patient has been seeing her Doctor of Dental Surgery (DDS) every 6 months for cleanings and preventative care. Dental health good for age. The patient has 6 crowned teeth and she was missing 2 teeth). No therapeutic measures were taken as a result of reported events. Event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events teeth clenching, fever, chills and persistent dental pain was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This is a spontaneous report from a Physician who reported for 3 patients and from a nurse via a sales representative. This is the second of three reports. A patient of unspecified age, gender and ethnicity received a single dose of PREVNAR13 at single dose on unspecified date. Patient medical history and concomitant medications were not reported. On unknown date the patient experienced swelling of arm, redness and pain. The outcome of the events was unknown. One of the patients called back to the doctors office to report the side effects and took a picture to show the reaction and sent it to the office. According to the reporter there was a reasonable possibility that this events were related to the suspect product.
WEAKNESS AND CONFUSION, SLEEPINESS, DIALTAED EYES, "LOOKING HIGH" ACCORDING TO WIFE AND DAUGHTER.  PARAMEDICS CALLED TO HELP LIFT PATIENT FROM THE FLOOR AS WIFE COULD NOT.  PARAMEDICS TOOK PATIENT VITALS AND STATED THAT THEY WERE NORMAL. PATIENT WAS NOT TRANSPORTED AND PARAMEDICS FELT HE WOULD BE FINE AT HOME.  PATIENT STILL HAVING MALAISE DAYS LATER.
Initial HCP report received on 08 Dec 2009: This patient (16 months old) was vaccinated with FLUVIRIN (batch unknown) on 08 Dec 2009. No other adverse event was reported. Following an internal review done on 11 Feb 2010 of the data received on 09 Dec 2009 following correction was made: The event off label use was coded.