chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MENVEO given 02-15-16. Left arm. IM. Patient and mother came to office 02-18-16 to report the site has been red, raised, hot to touch and itching since arriving home 02-15-16. Alternating TYLENOL/ibuprofen as needed. Tried some BENADRYL. Area is getting better, but still 3 inches by 3.75 inches - red, slightly raised. Cool now and much less itching.
I took all 3 shots. My pneumonia and flu shot in my right arm and my shingles shot in the left arm. Both my arms were really sore and couldn't hardly lift my arm. Had a really bad rash on both arms, and also really sore under my arm pits for several days and ran fever also.
friend who had Pfizer booster, diagnosed with Bullous Pemphigoid; can not walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 20230717306.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunisation series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PEMPHIGOID (medically significant), outcome "unknown", described as "friend who had Pfizer booster, diagnosed with Bullous Pemphigoid"; GAIT INABILITY (medically significant), outcome "unknown", described as "can not walk". Clinical course: 8 months after a friend who had Pfizer booster, diagnosed with Bullous Pemphigoid, she had blisters all over her, spending her life savings to get help not covered by her health Ins, can not walk, using diapers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported to pharmacy that his arm had localized redness, pain and swelling encompassing about 6 inches of the arm where he was vaccinated. Follow up with patient on 10-3-17 showed these symptoms began to reside. No issues with itching or breathing.
information has been received from a certified medical assistant concerning a 51 year old male with high blood pressure, obesity and no known allergies or adverse drug reactions reported. On 25-JAN-2007, the patient was vaccinated intramuscularly in the right deltoid with 0.5 mL of Pneumovax (lot#654977/0888F). At the same time, the patient received influenza virus vaccine (unspecified) in the left arm. Concomitant therapy included LOTREL. The following day, the patient developed a high fever, aches and swollen right arm. It was reported that the patient was also "nauseated". The patient sought unspecified medical attention. The patient received an injection of DEPO-MEDROL and an order for MEDROL DOSEPAK. the symptoms had resolved. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
On 03-30-2020 patients spouse spoke with PCP stating patient after Leaving the office on 12-11-19 she made it home but was unable to walk. She has improved but is still weak and feeling very tired.
This case was reported by a consumer and described the occurrence of injection site erythema in a 12-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema, injection site pain and allergy. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the allergy was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and allergy to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO in an unknown arm. This evening, a patient relative had reported pain and redness at injection site (arm). It had lasted several days. The patient had returned to the public health clinic and the nurses said it was an allergy through this was not clear. Its painful and worrisome enough for her mother that they called to reporter and asked what they should do. The reporter had suggested they speak with their pediatrician and referred them to the BEXSERO risks and side effects page on the web.
Menactra was administered 6/26/07. Patient had soreness in neck and stiffness in back later that day. Had temperature of 100 degrees the following day. She called physician who instructed her to notify us.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had no real issues with the first shot (1/4/2021).  Little swelling/redness.   2nd shot was  not as smooth.   Major arm pain.  Fever (highest was 100.9)
fully vaccinated and booster'd by Pfizer/tested positive for Covid; fully vaccinated and booster'd by Pfizer/tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "fully vaccinated and booster'd by Pfizer/tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller tested positive for Covid, was prescribed Paxlovid. Therapeutic measures were taken as a result of covid-19. Clinical course: Agent states caller has refused to provide demographic information, stating that he was already called and provided information and then was hung up on. Caller tested positive for Covid, was prescribed Paxlovid, finished the medication and now a week later he can't swallow and his throat feels swollen and he wanted to know how long this will last?Caller states a full week after finishing Paxlovid he began having an extraordinary bad problem swallowing and it feel like something was stuck in his throat. Caller states he went to an Urgent Care about it was told that his symptoms were due to Paxlovid causing tremendous digestive problems like acid reflux due to the acidity of the medications. Caller says he have to eat applesauce for a while.Caller ask if this was normal to experience this after he took the drug, a week later and if so how long will this last?Caller says this was awful, it's painful and he can't even drink water, that's how bad it was. Caller provided contact details. Caller says he does not feel well and does not want to continue to hold. Caller requested a callback. Successful callback attempt made 05May2022 at 3:11pm. Call recording disclaimer provided.Caller disconnected the line.Unable to offer survey. Agent AE duplicate with potential new details E-transmitting. Caller was a male unable to ask age.Caller says he has a real problem with Pfizer and will file a formal complaint. He was a healthy male who is fully vaccinated and booster by Pfizer. Caller says, "This was truly ridiculous. He should have never been placed on this drug in the first place but that's an issue he have with his Dr."Caller later said, "He Just got off the phone with a Pharmacist who said she's had reports that this medication can linger in your body for two weeks.How is it the general public knows this but you guys say you know nothing about this? he need legal department to call him. He need to speak with someone in clinical department he want them to call him today.Caller hung up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist via Pfizer regarding a female patient of unknown age. No information was provided regarding relevant medical history and concomitant medications. On 13-MAY-2016, the patient had received PREVNAR 13. On 25-MAY-2017, the patient received PNEUMOVAX 23 for prophylaxis (dosing details not reported). On 25-MAY-2017, the patient experienced pain and was unable to move her arm where the vaccine was administered. The pharmacy would be sending the patient to get medical attention. Outcome of the events was reported as not recovered. Causality of the events was reported as related. Additional information has been requested.
elevated temp mom said 103.6 2 hrs p/MMR vax - dizzy, h/a, rt ear pain, fatigue; temp @ office on 9SEP92 100.4 oral; mom said fatigue before MMR;
Arm swelling in diameter of five inches of injection site, red and warm started day of injection and resolved without intervention three days later.
Patient reported swollen lymph nodes in his throat several days after second shot.  It is mild and ongoing, and will follow-up is worsens or doesn't go away.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:17 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 75.58.  Concomitant medication of the patient was not reported.  Batch number 022M20A underwent temperature excursion on 17-Feb-2021 with temperature of 22 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 11-Feb-2021 and beyond use date for the vials was reported as 13-Mar-2021. The vaccines moved to clinic on 17-Feb-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and a brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case : 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910: Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA009929: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
Had headache, fatigue, brain fog for 3 days also very sore arm. On day 8 after the vaccine my arm became red with an area the size of a silver dollar , below the injection site. My lymph nodes under my arm were swollen and sore and also lymph nodes above my clavicle on the right. I still feel fatigued and I have a full feeling around the area of my right upper abdomen ( liver), I dont have a gallbladder. Otherwise, I am OK. Just wondering about the 2nd dose. Lymph node still slightly swollen above clavicle.
CHILLS 3-4 HR DURATION,FATIGUE.AND MUSCLE ACHES
Pt's daughter called to report her father's reactions after dose 1 of pfizer vaccine.  about 4 hours after receiving the vaccine, he started to experience a headace,  facial swelling, puffy, watery eyes, and nausea.  This morning his symptoms have worsened to severe headache, continued facial swelling and double vision.  Daughter was advised to bring pt to the ed for evaluation.  Allergy consult has been requested.
This spontaneous report as received from a physician refers to currently 11 years old male patient with low Immunoglobulin A (IgA). On unknown date (as infant), the patient was vaccinated with a dose of haemophilus b conjugate vaccine (manufacturer unknown) (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. Physician reported that the patient received a complete haemophilus b conjugate vaccine (manufacturer unknown) series as infant and "now" (July of 2012) had a low "hib" titer of 0.21 (units not reported). No treatment information was reported. At the time of report, the patient's outcome was reported as not recovered/not resolved. The relatedness for the patient's event was not reported for Haemohilus b Conjugate Vaccine (manufacturer unknown). Additional information has been requested.
That evening, body aches and by 09:30pm I had a fever of 102-103. I was hurting and I was fatigued. When I woke up the next morning, I=it hurt to move, breathe, or even sit. Every muscle and joint hurt. By 03:00 that afternoon, my fever went to 103.1. I had a horrible pounding headache, too, the whole time. I stayed in bed all the day. When I woke up the next morning after that, fever was gone. I was still aching - muscles of upper arm  (bicep) and thighs, knees,  hip, ankles, hands. They weren't hurting as much as they had the day before but still  hurting. But the joint pain never went away - I have a flare up every two or three weeks when muscles hurt again, too. In my joints in my fingers, they stay swollen  - like when I have an osteoarthritis flare up. Those joints have really never gone back down to size since then. They've stayed swollen. My feet have hurt the entire time. It literally hurts to walk some days - every muscles and joint in feet hurt. Knees and hips - those really hurt badly.  I never had this achiness before. I had to have a reason for it before (achiness)  - with hard work I do on the farm but now it's all the time of feeling achiness. I was taking three Ibuprofen three times a day. I had to stop that because I developed two ulcers. I have had to stop and take turmeric which doesn't help as well. Every day there is a continuing ache in my joints. The back of my  hips - the lumber spine - hurts - it is always there....part of that is that I could have worn that out. I'm still hurting. I was told to take Naproxin when it gets really bad. I want the Ulcer to heal so I don't take that very often. I take a low dose aspirin and ginger capsule and the Turmeric currently.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 384 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
missing second scheduled dose resulting in deviation from IMOVAX schedule for pre-exposure with no adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA349373(CLUSTER).  This case involves a 35 years old male patient who missed second scheduled dose resulting in deviation from RABIES (HDC) VACCINE [IMOVAX RABIES] schedule for pre-exposure with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient missed second scheduled dose resulting in deviation from RABIES (HDC) VACCINE for pre-exposure due to his dose leaking with no adverse event (routine immunisation schedule incomplete) (Powder and solvent for suspension for injection) (unknown latency) (Frequency = ONCE) (Strength = standard) (lot V1E121M and expiry date: 04-Oct-2024).   It was reported that "Caller reporting a dose of IMOVAX leaked while the nurse was preparing for use, "the plunger came apart from the syringe and all of the vaccine leaked out of the back" of the barrel of the syringe. The leaking occurred while the nurse was "drawing up" the vaccine, the plunger separated from the syringe and all of the vaccine leaked out the back of the syringe by the plunger stopper. The vaccine then ran down the nurse's arm and onto the floor. Unknown to caller if the plunger came all of the way out of the barrel of the syringe. No other doses available at clinic. patient received first dose on 30-OCT-2023 and missed second on 06-Nov-2023."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. On 2nd May 2018, the patient received SHINGRIX. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema were unknown. The reporter considered the extensive swelling of vaccinated limb, injection site itching, injection site warmth and injection site erythema to be possibly related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. On 4th May 2018, the patient experienced injection site swelling with diameter more than 100 mm, itching, warm and redness. Duration of adverse events were reported as 3 days, however event outcome were reported as Unknown.