chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild soreness in arm lasting 3 weeks; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 03Apr2021 at 06:00, the patient experienced mild soreness in arm lasting 3 weeks. Has n. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mild soreness in arm was recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: 22K-163-4510288-00. A 53-year-old female patient received BNT162b2 (BNT162B2), on 04May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years intramuscular for COVID-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, single, Route of administration: Intramuscular), administration date: 29Mar2021, when the patient was 52-year-old, for COVID-19 immunisation; BNT162b2 (dose 2, single, Route of administration: Intramuscular), administration date: 19Apr2021, when the patient was 52-year-old, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "Shoulder discomfort". The action taken for adalimumab was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-PV202200050135 same patient/drug, different dose/event;
after 6 days, rash on chest and back,  puss filled blisters that turn into open sores, then Sinus infection bloody green snot for 3 weeks bloody nose every night, sore throat, swollen glands right side of neck only, right ear ache,  then hives on my extremities that immediately filled with puss and popped and turned into an open sore. After three weeks the dr allowed me into the office to treat my draining sores and sinus infection. he said it was impetigo. and gave me Bactrim
Loss of vision in left eye for several hours, large hematoma at injection site and arm/shoulder pain.
Strange taste in my mouth; My tongue and lower lip was tingling; My tongue was swelling and it did not feel normal; This is a spontaneous report from a contactable consumer (patient) and other HCP. A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported, Expiry date: unknown, Age at the vaccination: 73-year-old), via an unspecified route of administration in Arm Left on 17Mar2021 17:15 as dose 1, single for covid-19 immunization at pharmacy or drug store. Medical history included diabetes, lots of allergies, Anaphylactic attacks due to Sulfa, Erythromycin and penicillin. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE; SITAGLIPTIN]) at 50/1000 mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Mar2021, the patient reported, within 1-2 minutes from the injection, strange taste in mouth, waited 25 min and went home at which time her tongue and lower lip was tingling. At that time, she had to go to ER because her tongue was swelling, and it did not feel normal. Treatment received was at hospital the doctor gave her Benadryl 50 mg, Prednisone 20 mg, 3 times a day (total 60 mg per day) and Pepcid 20mg twice daily for 3 days all of them. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 was no. Outcome of events was recovering.  Information on the lot/batch number had been requested.
A consumer reported that her 26 month old son received a 3rd dose of Prevnar vaccine on 2/13/02 when he was 15 months old. According to the mother, the child began to show symptoms of autism at 18 months of age. He has been seen by a physician and a specialist, but has not yet been diagnosed with autism. The mother states the child does not yet talk, slaps hands, attracted to spinning objects, will only eat 2 different food items, no imagination, and bites himself on his hand. Laboratory tests include nuclear magnetic resonance imaging (results unknown). This case was serious since this event was considered medically important for this case (OMIC). No additional information was available as of the date of this report. Follow up info received on 4/4/03 from physiican. Physician confirmed consumer report and reported additional concomitant vaccines were administered on 2/13/03. Physician reported that child was seen for 15 month well check on 2/2/03. According to the physician, at that visit the child was "noted to have delyaed expressive speech" and therefore showed "the earliest signs of autism at the time of vaccination with Prrevnar, 3rd dose." The physician also reported "these vaccinations also could not be rationally responsible for the child's developmental delays." A consumer reported that her 26 month old son received a 3rd dose of Prevnar vaccine, 1st dose of MMR II and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed on 2/13/02, when he was 15 months old. According to the mother, the child began to show symptoms of autism at 18 months of age. He has been seen by a physician and a specialist, but has not yet been diagnosed with autism. The mother states the child "does not yet talk, slaps hands, attracted to spinning objects, will only eat 2 different food items, no imagination, and bites himself on his hand." Lab tests include MRI. This case was serious (OMIC) since these events were considered medically important for this case. No additional info was available as of the date of this report.
Rash noticed by mother at 7 pm. Started on L side of abd. spread to other side then arms and legs. Temp of 103. Rash increased until pm of next day. Mother called after hours clinic. Nurse told her there was nothing they could do. Baby checked at dept on 1/12/03 patches of light red rash on abd and legs. No fever.
pt recvd vax & subsequently exp numbness, tingling & difficulty walking; pt recovered in approx 2 wks;
I woke up my whole bed and my clothes were sweaty, my bed was sweaty; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,Lot Number: EW0179 and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient stated that he just had the shot on the 25May2021 and the last night, the first night after he got the shot on the "26th" (further not clarified) he did the same thing. The patient stated that when he was sleeping and he was awake and had sweating so much in his bed and had protective pad underneath his sheet and it was soaked wet. He woke up his whole bed and his clothes were sweaty, his bed was sweaty and second night the same thing happened. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
25 pts recvd Engerix-B & 24 exp immediate severe burning @ local inject site (3rd shot for 80%); w/in 2 minutes event abated-no sequelae x/minor soreness;
headache and body ache began within 45 minutes of the injection, headache was intense. the concerning symptoms tho began the next day. i could feel areas of chronic injury flaring up -- my right IT band and knee from jogging, my neck from a car accident 2 years ago, ankles, wrists, and a muscle in my lower back/upper buttock. it was as if the vaccine triggered an over-active immune response in all places where i have chronic pain/injury. my right knee swelled and is still slightly swollen and hurts to walk on it, even today. my dad told me he had similar reactions from the 2nd pfizer vaccine, fyi.
drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination
General body aches, compressed feeling. chills, second day big headache  , cold and hot feeling , pain in lower neck and  spine, today minor headache and tired. sore arm all days.
Right arm between shoulder and elbow became swollen about 6 cm and heated to touch per dad.
Within a few hours of receiving the Bexsero vaccine Friday late afternoon, his right arm was in extreme pain (not normal vaccine ache/tenderness like his left arm was having) to the point of not being able to lift his right arm. It continued to hurt so badly he was taking 2 advil several times a day to help. Ice did not help alleviate any of the pain. There was no redness, swelling or marked heat in the area of the vaccine. On Monday, Tuesday, Wednesday, and Thursday of that week he could barely write to get through school. Thursday, Friday and Saturday the following week he continued to have pain but it began to decrease each day. There was still intermittent pain for at least 2 full weeks after he received the vaccine.
VARIVAX was administered following temperature excursion.; No adverse effects or symptoms following administration; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided by the reporter.  On 15-MAY-2022, the vaccine underwent a temperature excursion of 6 Fahrenheit (F) for 7 minutes. There was no previous temperature excursion. Following the temperature excursion, on 23-MAY-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, lot# U020244 with expiration date 28-JUN-2023 (strength and route of administration was not reported), administered for prophylaxis. No adverse effects or symptoms following administration.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001549: US-009507513-2206USA001561: US-009507513-2206USA001318: US-009507513-2206USA001331: US-009507513-2206USA001347: US-009507513-2206USA001558:
Said she had muscle weakness was in bed from 830pm to 830AM (couldn't get out of bed) - layed in bed for 12 hours. Fast heart beat. Shortness of breath; also low blood sugar reading in the am, the next day.
Information has been received from a physician concerning a 16 year old female patient, who on 04-OCT-2010 was vaccinated with a first 0.5 ml dose of GARDASIL (route and lot # not reported) and on an unspecified date received her second 0.5 ml dose of GARDASIL. Concomitant  therapy included hormonal contraceptives (unspecified), "oral contraceptive". The physician reported that on 16-DEC-2010, after the second dose of GARDASIL the patient experienced chest pain. The patient saw her Pediatrician and her Pediatrician suggested her to see a Cardiologist. The patient was diagnosed with Raynaud's disease. The patient's Cardiologist strongly suggested not getting the third dose of GARDASIL. At the time of the report, the patient's out come was unknown. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008621, expiration date 04-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
after 10 minutes patient had loss of consciousness with spontaneous recovery evaluated by telehealth physician and sent to ED at hospital in stable condition for further monitoring and testing as needed.
Small numbers of chicken pox Lesions beginning within two days and ongoing since vaccine. Body aches after shot and headache    Rash Clears but returns and is basically ongoing on extremities   I was not tested for antibodies which has been done in the past and have not needed the vaccine in other places  but was not give. as an option at that time or in this state I was told it would just be better to ?make sure?
Upon check-in the patient presented and reported she was due for a Pfizer vaccine.  The patient confirmed in the exam room prior to vaccine administration she was presenting for her 2nd Pfizer.  The Pfizer vaccine was counseled and fact sheet provided.  After administration of the vaccine it was discovered that the patient had received Moderna, not Pfizer, as the first dose.
General fatigue, slight fever,  swelling around both sides of my neck/collarbone area. This occurred about 10 days after 2nd vaccine.
Small lump in the head; This is a spontaneous report from a contactable pharmacist (patient's husband) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14May2021 (lot number: EW0179; expiration date: 31Aug2021) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her 1st dose of BNT162B2 on 14May2021. The pharmacist can't remember the date for the 2nd dose. The patient was feeling good and was not experiencing any side effects. However, the one thing that the patient was experiencing was a small lump in her head. The pharmacist explained that the you can feel the small lump in the patient's head but you can see it. This showed up once she took the 1st dose of the vaccine. The pharmacist stated that the exact date for the event was 2-3 days prior to the time of the report, on the 18th or 19th of May but he was not sure. The outcome of the event was unknown.
This spontaneous report as received from a pharmacy technician refers to a 6-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 30-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
On October 7th, I started getting a chest cold with lot of coughing, when sitting got worst and go to pneumonia. Sunday afternoon, October 9th, I went to the clinic, I was giving antibiotics and inhalator and breathing treatment.
Eight days after receiving my first Covid 19 vaccine I woke up with a bright red, raised, warm to the touch, area around the injection site. It continued to enlarge over a 3-day period. It expanded from a 2" inch area to approx. 6" wrapping around part of my left arm. It was slightly itchy, mildly uncomfortable. It did not decrease in size or redness for 8 days. Now what you can see is a faint mark where the redness occurred. Doctor prescribed a double dose of benadryl for 3-4 days plus pepcid every 6-hours. This did not seem to make an appreciable difference.
hives on my neck and above my ear/few sparse hives; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received bnt162b2 (BNT162B2) lot number and expiration date were not reported, via an unspecified route of administration on 16Dec2020 at 07:15, 0.3 ml single dose for immunization. Medical history included seasonal allergy and seasonal asthma. The patient's concomitant medications were not reported. The patient stated that she received the product this morning (16Dec2020) at 0715. She mentioned that she took a shower this evening, 13 hours later, and observed hives on her neck and above her ear. She confirmed that she was not having an anaphylaxis and there are no other symptoms. She also denied any soreness at the injection site or pain. She stated that she has no other symptoms and no pain, no soreness. She added that she received vaccine on 16Dec2020 and wondered if there was a side effect of some hives, she meant that she was not having an allergic reaction and she got the vaccine at 7:15 this morning and she have been fine, but she just have like a few sparse hives at 20:30. When asked about causality, the nurse stated "Yes I do. I have never had hives before." She did not think that she needed treatment but she was wondering if it was common or she wasnot having any anaphylactic reaction and they were sparse. She doesn't have it on her trunk, she just have some on her neck and there was like one above her ear. She put BENADRYL cream on them, they are fine, and they don't itch. She was just like preemptively treating them because of her high risk for work.  Therapeutic measures were taken as a result of hives on my neck and above my ear (urticaria). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Extreme Dizziness (fell twice - no injuries) Lasted past Midnight. Rest. Will report this to my MD on Monday.
Within 1 min of receiving vaccine, child fell to right side, pale, eyes rolled back, brief body tremors/jerking (5 seconds). Given O2 and sugary drink. Pt monitored 30 to 40 min. then discharged.
8-10-09 Received varicella vaccine. 8-11-09 Site became red and swollen and stayed that way. Area involved in oval shape-approx 1 1/2 x 2 1/2 inches with raised area around perimeter. 8-22-09 A few pox appeared on abdomen. 8-24-09 More pox on face and body.
Rash and itching, primarily on my shoulders, upper arms, neck, and head. Some relief via antihistamines and anti-itch creams.
A few hours after receiving 2 vaccinations pt noted tenderness in area - left upper arm. Red raised and pain emanating from injection site down arm, to axilla, radiating to shoulder/neck.
About 45 minutes after my shot the left side of my face began to get tingly and numb.  (Like when you have had dental work and the feeling is coming back) This continued for about 3 days.  I also had a very bad headache Thursday-Friday and then a low grade fever Friday afternoon.  I never have a fever.  I cannot tell you the last time I had a fever.  I contracted Covid in October and did not have a fever then.
CDC reports: 2 yo child developed fever 101.2 & approx 30 min p/immunization began crying & vomited 5 or 6 times, also became drowsy, nausea tx Dramamine syrup, duration of illness 2 days.
The patient had an acute neuromuscular toxicity reaction. She was seen in 5 hospitals after the symptoms of progressive weakness and paralysis started in her feet and moved to her head and neck. She was tested for Gillian -Barre and other viral illness and all were ruled out.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 26-NOV-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013859, expiration date: 14-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Fever, chills, nausea, severe headache lasting about 5 hrs. Headache lasted longer, pt. slept all day on 8/18/11. All symptoms resolved by 8/19/11.
Double vision - diagnosed as 6th nerve palsy in right eye.  Could take up to 6 months for normal vision if then.  Have seen eye doctor and neurologist.  Have to wear eye patch.
Flushing of the face; Rapid heart beat; Elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, AMLODIPINE, PHENYTOIN (DILANTIN [PHENYTOIN]) and LEVOTHYROXINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 21-Feb-2021, FLUSHING (Flushing of the face), HEART RATE INCREASED (Rapid heart beat) and HYPERTENSION (Elevated blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included BENADRYL.
Case number PHEH2016US023525, is an initial spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 46 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 1618701, expiry date: April 2017) at a dose of 0.5 ml, intramuscularly on 10 Sep 2016. It was stated that, patient received FLUVIRIN following 1st time temperature excursion of 52.9 Fahrenheit for 1 hour and 25 minutes. No adverse event was reported following this medication error (incorrect product storage). Upon follow up the pharmacist reported, 5 doses were administered following first temperature excursion. FLUVIRIN vaccine underwent second maximum temperature excursion of 46.58 (units unspecified) for 10 minutes. No vaccine was administered after second excursion. Follow up report received from a pharmacist on 12 Sep 2016: Updated suspect drug information (expiry date) and pharmacist comments. Updated narrative accordingly.