chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore upper left arm and unable to lift the whole arm to touch top of head; tingles down the left arm; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. On 02Apr2021 at 11:45, the patient experienced very sore upper left arm,almost was unable to lift the whole arm to touch top of head and had tingles down the left arm. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcomes of the events very sore upper left arm, unable to lift the whole arm to touch top of head and tingles down the left arm was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, joint pain, chills, fatigue, dizziness, shortness of breath
So within ten minutes of receiving the vaccine, my chest area was completely covered in hives. It started off small and then covered my chest, I walked over to the nurses and they called the EMTs. They checked me and my throat to make sure it wasn't closing up. Within twenty minutes it started to go down (the redness). In an hour I had some tingling all over my body. I spoke with my PCD the day after the vaccine and then physically saw her. Now we are much after the vaccine and I see a neurologist suggested by my PCD, because I have random numbness in my fingertips and body and I also experience a lot of fatigue, very tired regularly. I also had a delayed menstrual cycle for about a week. I also felt cramping on my fingertips and toes.
Diarrhea started 4-5 hours after the vaccine and presented multiple times daily for the following 4 weeks.  Diarrhea currently occurs multiple times weekly and formed bowel movements are not the same consistency as prior to the vaccine.  Lower energy since the vaccine has also been experienced.
Patient was given live vaccines while taking Ilaris, which should not be given/taken at the same time. Patient/guardian is not reporting any adverse effects.
Severe fatigue (two days), injection site soreness (two days), dizziness (for several hours after vaccination).
This spontaneous prospective pregnancy report was received from a physician assistant and refers to a currently (at the time of reporting) 17 year old female patient. The patient's concurrent condition included asthma. The patient had no concomitant medication nor drug reactions or allergies. On 07-MAR-2017, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneously, lot # M031969, expiry date 30-JUN-2018, for prophylaxis. After the patient received VARIVAX, the patient's chart was "reviewed" and it was noted that the patient was pregnant at the time of the VARIVAX administration. The patient's last menstrual period (LMP) date and estimated date of delivery (EDD) were not reported. The pregnancy outcome was pending. There were no lab diagnostic studies performed. Additional information has been requested.
no adverse event; MMR II was improperly stored and administered; This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  Since 08-JUN-2021, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) was stored at 55 Fahrenheit (product storage error). The vaccine had no other previous temperature excursion. On 06-JUL-2021, the patient was vaccinated with this improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) for prophylaxis (strength, dose, and route of administration were not reported; lot number S037497 was verified to be valid lot number, expiration date was 20-NOV-2021). No additional adverse event was reported. The vaccine was stored at 55 Fahrenheit until 03-AUG-2021.
pt devel chronic diseases 3 days post vax asthma;NOV97 juvenile diabetes;allergies to everything (between 92 & 97);
Red hard area approximately 1.5 x 1.5 inches. Itching. Significant pain- child limping. Swelling of site.
was given Moderna COVID-19 Vaccine on 1/20/2021 for her 1st dose of the vaccine, when she came back for her 2nd dose she received Pfizer COVID-19 Vaccine on 2/24/2021.  was followed up after the medication error. No signs or symptoms were reported during follow-ups
On April 13th, 2021 a 16 year old came into our facility to receive a Moderna vaccine. Her parents had signed her up, ignoring our walls that prevent anyone below the age of 16 to register for the vaccine, and made an appointment for her. They also put the wrong date of birth to show that she was 19 years of age. Our medical staff realized that she was 16 years old after she received the vaccine. The staff monitored her to make sure that she was alright for a while after the vaccine. The parents were contacted to explain the situation and to ask them to monitor her closely over the next few days. They were also instructed to take her for an appointment to her PCP. Moderna was also contacted to explain the event. They directed me to keep in contact with the family to ensure that she is alright. Moderna also mentioned that they were not overly concerned about the event.
Let me start by my wife also works at Tech and got the shot right before me.  So, I was comparing my symptoms to hers.  We both complained about pain and swelling at the injection shot but my swelling was much worse than hers.  You could tell that my shoulder was swollen just by looking at my arm with my shirt on.  So, I knew from talking to everyone that took it that my injection shit should hurt for a couple days so I thought that everything was normal.  Then after about a week it had not gone away and even started to hurt worse.  I have gotten to the point that when I have any type of physical activity my shoulder starts killing me.  It's real sharp pains that cause me to stop what I'm doing and sit down and hold still until the pain fades.  So after about 11 days from the day of the vaccine my wife walked into the kitchen where I was trying to make dinner and had stopped and closed my eyes standing there in pain.  She said, if it hurts that bad you need to see a doctor.  So the next day I visited my doctor and he didn't really know what was causing it .  It had been 12 days since the injection and you can still slightly feel the  place in my arm.  He gave me a medium dose of  steroids and a antibiotic to see if something like that will help.  Early on I was putting ice packs on it and taking hot showers with the  hot water stream directly on my shoulder.  One strange thing about it is  it only hurts after/during activity and the pain is at other locations like running up my neck  and around the back of my shoulder.  I feel like it's something  with the joint or nerves because of that.  The only thing that seems to help is my not moving it.
Day of swelling and redness at site.  Went away after a few days .  8 days later hot , red swelling spreading outside circle drawn by doctor.  Entire arm aching .
Transverse Myelitis; This is a spontaneous report from a contactable physician, the patient.   A 66-years-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 12Jan2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced transverse myelitis on 22Aug2021. The patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 23Dec2020 as single for covid-19 immunization. The patient was asking if there had been reports of this diagnosis this far out from the Pfizer COvid-19 doses. He knew it can usually occur in the first few weeks to months after vaccination, from his understanding. The outcome of the event was unknown.  The patient was advised by his neurologist as well as PCP and other physicians not to receive the booster dose of the Pfizer Covid-19 vaccine, but is wanting Pfizer's recommendation on this decision.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of transverse myelitis cannot be excluded.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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Received vaccine about 9AM, 07/12/2004, school entry physical exam.  Awoke 1AM with pain, fever of 101.4 degrees and swelling.  Patient reports tiredness and throbbing arm, despite Ibuprophen 800 mg every 8 hours.  Prescribed cephelexin 500mg 1 a day for 7 days.
Initial report received from a consumer on 06 February 2014. A patient (demographical details was not reported), whose medical history and concomitant medications were not reported, had received FLUZONE (batch number: UH889A, Exp. Date: 10 JUN 2014, route of vaccine administrtaion was not reported) in the right arm and had received Pneumococcal (Polysaccharide) ( 23 Sereotypres) vaccine; pneumonia shots (batch number, route of vaccine administrtaion was not reported) in right arm, both on unspecified dates.  On an unspecified date, the patient experience arm to swell and was red with fever in it. As a corrective treatment, the patient put ice on it for the swelling and it  hurts for 5 days. Laboratory data were not reported. As of 06 February 2014, the outcome was unknown. Documents held by sender: none.
Neck swelling began the day after receiving the vaccine.  Vaccine was given the left arm, swelling was in right side of neck.  He presented to the ED approximately 48 hours after vaccination with profound swelling in right neck.  CT scan showed swelling of submandibular gland without any abscess or sign of infection.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 18-FEB-2014, the patient was vaccinated with a dose of PNEUMOVAX 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 degrees Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status as reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "refrigerator (R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient felt nauseated and then passed out very briefly. He seemed confused for a couple minutes and at one point looked like he might have been having a seizure. His eyes rolled and arm started twitch. It only last a few seconds. He was sweating and very warm. His blood pressure before EMTs arrived was 75/41 with a pulse of 55.  EMTs came and checked him out. His blood sugar was 130. His blood pressure returned to normal after a few minutes and he started feeling better. He declined going to the hospital and the EMTs walked out with him when he was ready to go to make sure he was ok.
On 03/16/2005, same day as Pediarix shot, temperature of 104.7 and baby started having seizures.  Upon going to the hospital, patient's mother was told patient possibly had a reaction to Pertussis which is in DTAP.  Patient will return for follow up visit on 08/23/2005.
sore at inj. site; breaking out on legs and top of feet; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), via an unspecified route of administration on the left arm, on 28Jan2021 at 14:15 at single dose for COVID-19 immunisation. Medical history included diabetes and allergies, both from an unknown date. Concomitant medications included unspecified "regular meds." On 29Jan2021 at 19:00, it was reported that the patient experienced sore at inj. site and breaking out on legs and top of feet. No treatment was received. The events were considered as non-serious by the reporter. The events did not lead to death, life-threatening condition, hospitalization, disabling/incapacitating, or congenital anomaly. The patent has not been diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior. The outcome of the events was unknown. The patient was vaccinated at a hospital.   Information on the lot/batch number has been requested.
Pfizer Bivalent booster was given in error, patient had the Janessen/J&J COVID shot first.
arrived to  post observation after his first dose of Moderna. Pt stated he was dizzy. Pt appeared pale. Pt was A+Ox4. Medics were called and initial BP was 88/40. Pt states hx of syncope after shots. Pt was given juice and water and was able to speak during his entire time in post observation. Pt began to state he was feeling better but just wanted to sit for a while. Pt was clammy and states "I knew this would happen". Pt BP and HR rose to WNL. Pt standing without dizziness. EMTs  released Pt at 1650  to continue monitoring a bit longer.   1630 Vitals BP 88/40 HR 50 RR 18 O2 sat on RA 98%  1635 VS BP 90/50 HR 70 O2 on RA  99%  1640 BP 108/62  1645 VS BP 112/60 HR 72 O2 Sat on RA 98%
Burning and itchy almost immediately; 3 inches in diameter red, raised area, warm at injection site and took aleve; on 10/29/16 2 other red, raised areas on arm with soreness in armpit.
Chronic Spontaneous Urticaria & Dermatographia?symptoms include hives, itching, writing like red marks on the skin.
10/24/2013 Mild other At noon the day of the immunization, patient said things were "spinning" for a few seconds and he felt dizzy. He said he felt like it was Meniere's disease but without the ringing in his ears he had a sore neck and shoulders, and felt light headed for the next two weeks. Client feels much better now (11/13/2013). Was instructed to follow up with his doctor.
This case was reported by a nurse and described the occurrence of cellulitis in a 4-year-old female patient who received FLULAVAL QUADRIVALENT (batch number PN75E, expiry date 31st May 2018). On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), pain in arm and mobility decreased. The patient was treated with antibiotics nos (Brand Names Not Known) On an unknown date, the outcome of the cellulitis, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the cellulitis, pain in arm and mobility decreased to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: On an unknown date on Friday morning, the patient received FLULAVAL QUADRIVALENT and in the evening, the patient had pain and could not move the arm. On Saturday morning, the patient's mother took the patient to the emergency room (ER). The patient was diagnosed with cellulitis. The patient was prescribed with antibiotics. The emergency room physician informed the mother that the influenza dose given was too high for her age. As per nurse, the patient was okay at the time of reporting.
pt recv vax AUG94 & 3 days post vax pt exp rash on legs, dizziness, back & neck stiffness, pain in arm (inj site), gen malaise;ER or MD visit was required;tx w/pred;
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
Low grade temp 99.9 F, myalgia and joint pain, especially hands and knees, fatigue.
acute anaphylactic shock; A.fib; blurry vision; swollen lips; Numbing sensation in her hands and lips; tingling sensation in her hands and lips; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (acute anaphylactic shock) and ATRIAL FIBRILLATION (A.fib) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ANAPHYLACTIC SHOCK (acute anaphylactic shock) (seriousness criterion medically significant), ATRIAL FIBRILLATION (A.fib) (seriousness criterion medically significant), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips). At the time of the report, ANAPHYLACTIC SHOCK (acute anaphylactic shock), ATRIAL FIBRILLATION (A.fib), VISION BLURRED (blurry vision), LIP SWELLING (swollen lips), HYPOAESTHESIA (Numbing sensation in her hands and lips) and PARAESTHESIA (tingling sensation in her hands and lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment for the events included diphenhydramine, metoclopramide, ketorolac, prochlorperazine and prednisone. The patient was advised not to receive the second dose of vaccine by her healthcare provider.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
After 2nd rabies vaccination, woke up in pool of sweat.  Noticed decreased ability to concentrate after 2nd, 3rd vaccination and shooting pain in left foot, and left hand and twitching all over in arm where vaccination given.  Intermittent twitching left calf after 3rd vaccination.  Muscle ache in left calf began on 10/25/2005.  Right foot twitching onset 11/25/2005.  Jaw tenderness onset 11/01-11/04.  Symptoms mostly resolved now except with slight jaw pain.
Extremely sore arm, 100 degree temperature, body aches, headache On 12/14/21, I woke with severe hives on left wrist and back. Photos available
Positive for COVID; Headache; lowgrade fever; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine and experienced headache, low-grade fever and a positive COVID-19 test.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (011J20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient started to experience headache and low-grade fever. It was reported that he had just received results of positive COVID-19 test. The date of test was not reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events headache and fever, a causal relationship cannot be excluded. The event Covid-19 is assessed as unlikely related to COVID-19 vaccine as the patient may have contracted the infection before receiving the vaccine.
Pt c/o left shoulder pain after 24 hrs of PNU immunization given.  On exam had left bicep with erythema and induration with streak on left axilla.  Starting at injection site.  DX with cellulitis and treated with antibiotic CEPHALEXIN.
A few hours after receiving the booster shot pain and swelling started to appear in the armpit of the arm where it was administered.  I'm experiencing fatigue, pain, physical weakness, fever and extreme sweating during sleep. I also can't sleep well. The swelling of the lymph knots continues. The Lymph knot right in the armpit is noticeably swollen and hard and condition doesn't seem to improve, even two days after. First two doses of the vaccine were not as intense.
first dose of Shingrix / November 22, 2019 / not received second dose yet; arm was sore the next day / arm was also sore / caused a sore arm too; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 22nd November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season (intramuscular) and PNEUMONIA VACCINE. On 23rd November 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced incomplete course of vaccination. On 24th November 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix in an unknown arm. After receiving 1st dose, the patient's arm was sore. The patient also received unspecified flu vaccine in the opposite arm and that arm was also sore. Pneumonia vaccine was administered in an unspecified arm and reportedly caused a sore arm too. The reporter did not consent to follow up. This case was linked with case US2020178102, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178102:Same reporter (husband´s case)
pt received kinrix and varicella immunizations on 1/10/2023. mom and patient noticed erythema and edema to L lateral upper arm 1/11/2023 in the morning... . which then increased significantly by 1/12/2023 [date of follow up visit at our office].. also c/o warm to touch, pruritis, and pain with pressure to area. pt reports multiple blisters that ruptured  (drained yellow pus). erythema surrounding location of kinrix administration.  Pt sent to hospital ER for further workup and evaluation. diagnosed with cellulitis. given one dose of abx and sent home with keflex (8ml TID x 7days).