chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her lymph node in her breast is killing her; breast pain/ she is not sleeping well due to the pain; thought she pulled a muscle at first; tired; not sleeping well due to the pain; This is a  spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number:  EL9267), via an unspecified route of administration on the left arm, second dose on 17Feb2021 at single dose, for COVID-19 vaccination. The patient's medical history was not reported.  There were no concomitant medications. Patient took the first dose of Pfizer-BioNTech COVID-19 mRNA vaccine (Lot: EL9264) on 27Jan2021 for COVID-19 vaccination. Patient got her second dose of the Pfizer Covid vaccine 17Feb2021 and experienced side effects such as painful lymph node and breast pain on 18Feb2021. She said that her lymph node in her breast is killing her on the side that she had the vaccine. She clarified that it is very painful and her breast itself is very painful. She said that she did go to the doctor to be sure that is what it was. She further reported that by Thursday night (18Feb2021), it started bothering and her breast started bothering her. She thought she pulled a muscle at first. She said that it has progressed and got worse and that Sunday night she was in agony. She called the doctor Monday for her left breast that hurts.  She said that she is taking ibuprofen (ADVIL, Lot: DJ6716, Expiration: Dec2022), taking 3 of them at a time, but it is not really helping. She had no reaction at the injection site. It is not red and you cannot see anything there. She said that is why she is not even sure. She said that there was no pain at all there. She said that there is nothing wrong with her and she does not feel sick, she just hurts. She said that she was tired because she is not sleeping well due to the pain. Patient wants to know what pain medication she could use that will not counteract the vaccine. The outcome of the events was not recovered.
25MAR93 1230PM mom called to report pt fell asleep after immun was hard to arouse; pt was very sleepy w/dec responsiveness the rest of the day & evening; today pt has been awake but is less active; t101;
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (lot # L022447 with expiration date of 09-JUN-2018; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Diagnosed by local Emergency Room with cellulitis after patient presented with redness and swelling in arm she received both vaccinations (patient had received both in same arm per her request) - patient was then prescribed a 10 day course of cephalexin 500 mg four times daily to treat
Hot and cold chills diarrhea started March 9, 2021  for 3 weeks now my loose stools  is loose and  I am having diarrhea never had a bowel problem before until i took The Pfizer vaccine on March 9 it is now May 5 and I still have the problem and weight loss Doctor is sending me for more testing  because I never had a problem before to find out why this is happening to me it Hass to come from the vaccination shot that?s when everything started happening to me
father states child ran temp 105;had sz was taken to ER & adm to hosp x 1 noc;was dx w/throat infect;had not had any sx before day of vax nor any day of vax;father reports child had been eating, sleeping normally, no complaints;
Skin prepped with alcohol. Given band aid applied. Pt cried; tolerated well. Double checked by LPN.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 19-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion below 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49. 1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA003310: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003311: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335: US-009507513-2202USA003592:
pt recvd vax; p/ 12 mins, rt arm a raised welt appeared at site of inject;was sent to er by MD;
Pt. Received Pfizer 5 yrs - 11 yrs in error recently turned 12 years and had received previous age group. Parents informed.
Not sure if attributable to this injection, but in July, as indicated in earlier section, developed a clot in right leg, great saphenous. Worth noting that this is the same leg in which I had a DVD in 2017 following emergency surgery for a broken hip. (Fun times.)
Headache, Myalgia, NauseaVomiting, Chills, lethargic
Frozen shoulder with multiple attempts for physical therapy 2 steroid injections (2/24/2020 and 5/5/2020)
Injection 1/17. Elbow, wrist, and shoulder joint pain severe to moderate ever since injection till today 2/4.
This spontaneous report as received from a certified medical assistant (C.M.A.), refers to a 12 month old female patient. On 13-AUG-2012 the patient was vaccinated with the first dose of VAQTA (Lot # not reported) (0.5ml, route not reported) and the second dose was administered on 13-AUG-2012 (Lot # not reported) (0.5ml, route not reported). No adverse event reported. Additional information has been requested.
Urticaria @ shot site DTP, LD 10 x 14 cm w/pseudopods, pt stable no systemic sx;
Child woke up covered with red rash from head to toe.  Some red blotchy areas per dad.
About twelve hours after receiving my vaccine, I got out of bed and I could not bear weight on my right leg and foot. The pain was excruciating. It was from the sciatic all the way down. I called my doctor to make an appointment, but my son drove me to the ER. While I was in the hospital they gave me a shot of a pain killer ( I cannot remember the name) and provided me with IV fluids because of minor dehydration. I was able to walk from the doors to the car, but it was still a tad painful. I was taking ibuprofen to help with the pain too. Day by day, I started to feel better. I was given a referral for physical therapy.
Woke up on 7/22 from severe sore throat,  later that day then got mild runny nose and body aches. Took Ibuprofen 800mg, Airborne 6 gummies (throughout the day), hot bath, Benadryl 25mg before sleep; 7/23 runny nose, towards the night developed moderate chest congestion, cough. Took Ibuprofen 800mg, Airborne 6 gummies (throughout the day), Benadryl 25mg before sleep; 7/24 severe cough, nausea, axillary lymphadenitis on the right. Started taking Musinex Fast-Max Day during the daytime, Musinex Fast-Max Night before sleep, warm compress to painful lymph node,  cough drops. 7/25 no more runny nose, still cough, laryngitis, almost unable to speak. Continue with Musinex, warm compress; 7/26 wasn't able to work - still cough and unable to speak, painful lymph node.
Diagnosed with fibromyalgia; Joint pain; This case was reported by a pharmacist via sales rep and described the occurrence of fibromyalgia in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHingrix (1st dose received in December 2019).   In March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, between 1 and 2 months after receiving Shingrix, the patient experienced fibromyalgia and joint pain. On an unknown date, the outcome of the fibromyalgia and joint pain were unknown.   It was unknown if the reporter considered the fibromyalgia and joint pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 56 or 57 years old. A little over one month after 2nd dose, patient started experiencing joint pain and had since been diagnosed with fibromyalgia. Patient called doctors office wondering if there was a potential that her joint pain was a lasting side effect from Shingrix immunizations. Blood work and testing had been done to determine what could be causing the patients recent on set of joint pain. Nothing had been determined as a cause. The reporter consented to follow up.
Extreme muscle soreness that has gotten worse as time went on.  After two months I contacted my Dr. and if it doesn't subside in a month will follow up with her.
This spontaneous report received from a registered nurse referred to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M025864, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
INJECTION SITE SORENESS IN LEFT DELTOID; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced injection site soreness in left deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness in left deltoid on 12-MAR-2021. This report was non-serious.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 17-AUG-2015, when the patient was 13 years old, was vaccinated with GARDASIL (lot # K010215 with expiration date of 17-JAN-2016, for prophylaxis) (dose, route of administration, and anatomical location were not reported). On 06-SEP-2017, when the patient was 15 years old, was vaccinated with GARDASIL 9 (lot # N010497 with expiration date of 15-JAN-2020) (dose, route of administration, and anatomical location were not reported). No adverse effects were reported.
Patient presented with itchy, red rash. She was advised to take an antihistamine such as Benadryl until she could see her provider later in the afternoon. Patient visited provider who prescribed the patient hydroxyzine for the itchiness.
12/3/08 pt started with "strangled cough" and body aches. 12/12/2008 Had severe vomiting and diarrhea- extremely weak and barely could walk-no stool cultures done. Pt prescribed anti-nausea and anti-diarrheal med. 12/17/2008 Pt achy, tired, and cough returned. 12/21-12/22/2008 Couldn't walk up steps describes legs feeling like jelly. 12/23/08 extreme pain in back and all extremities, but pain only at night. 12/24/2008 Burning electrical pain continued but only at pm. 12/26/08 pt to emergency room-no reflexes present in lower extremities. Admitted to ICU. Seen by neurologist and diagnosed with Guillain Barre Syndrome. Pt had lumbar puncture, MRI, nerve conduction tests. Given IVIG for total of 5 days. 2/6/09 Pt still has residual weakness and compacted feeling in hands.  2/11/09 Received hospital medical records of 12/26-12/31/2009. FINAL DX: Guillain Barre syndrome; cervical spinal stenosis Records reveal patient had stomach flu approx 2 wks prior to admit w/N/V/D that resolved after 3 days.  Developed weakness/numbness of limbs, difficulty walking, & pain in her back x 3 days prior to admit.  Neuro consult done.  Areflexia & loss of sensation of legs.  LP done.  Tx w/IVIG x 5 day w/improvement.  D/C to home w/outpatient PT.  2/16/09 Received CSF results.
Hearing loss; This is a literature report.  A 78 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunisation.  The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss". The event "hearing loss" was evaluated at the physician office visit.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
11:30 starting feeling chilled for about 20 minutes, then it stopped. 1:00 p.m. chills again and dizzy, then stopped after about an hour. 3:00 pm  headache and minor body aches, fatigue, which got increasingly worse.  9:00 p.m. more severe body aches. Fever of 101.3, severe body aches, and chills, shaking lasted from 1:00 a.m. to 1 p.m when chills stopped. Fever, sore arm, and severe body aches went on for about 36 hours, when sweats broke out and then the fever was suddenly gone. Fatigue and malaise continued for another 48 hours and when I woke up suddenly it was like nothing had ever happened. It went away that fast.
I woke up the next morning with fever, body aches, sore arm, chills, and fatigue. Two day later, I developed painful sores along the roof of my mouth, and it became difficult to eat. I called my doctor and she believed it was an inflammatory response to the vaccine. She offered a medicine to reduce to reaction, but I declined. They finally went away after 4 days.
Narrative: A 48yo obese male with PMH of multiple medical problems which  include Hyperlipidemia, DM, Traumatic Brain Injury, Mild cognitive Disorder,  Traumatic Arthritis, Arthralgia of ankle and foot, Chronic Back Pain, Chronic  PTSD, Asthma and Sleep Apnea. He received his first Pfizer Covid - 19 vaccine  per protocol at the hospital, on October 6, 2021, Per Primary Care Secure messaging  to the ADR reporting Unit's Clinical Pharmacist, on October 14, 2021 ; The  patient reported Pfizer Covid -19 vaccine induced ADR of Facial Numbness,  Trouble Breathing and Spiking blood glucose level.
I do not have the exact manufacturer listed on the chart. The onset of the allergic reaction was 4 days after the administered vaccine, 7/9. Redness in the area below the injection site - about 4" where the injection site was. It started with red patch and slowly got bigger each day. I have taken photos of the area about 3 days into the reaction - 7/12. The last dimension I recorded was about 3 x 5.5". To this date, I still have redness further down in my left arm and am still treating it with ice compress and some Aloe Vera to alleviate the itchiness - which started Thursday, 7/13. The clinic prescribed an anti-biotics called Cephalexin (Keflex)on 7/10,  since my Primary Care Clinic cannot accommodate me at that time. The provider's diagnosed was Cellulitis. Without improvement on that Monday, I called the Clinic again, Tuesday, 7/11 and the available nurse said to go to the Urgent Care to have the shot site seen by a Medical Doctor. I went in the Urgent Care first thing in the morning of July 11 at around 10:00 and the attending doctor from reading the previous diagnosis said that it is indeed a Cellulitis. There were conflicting information I am receiving so I went back to the clinic the following morning, 7/12, to try to resolve my concern. This time I am still not able to see my Primary Care since they cannot accommodate me. The attending PA in the Clinic prescribed a different antibiotics to help alleviate the redness and swelling. Right after this appointment, I decided to go to my Primary Care Physician Doctor's clinic without any appointment and begged to be seen by any nurse present in the clinic with the hope that it will call the attention of some doctors in the clinic. I was finally seen by my Primary Care Doctor and he examined the affected area. His diagnosis is that he is sure that it is not an Infection but rather a local reaction to the TDAP Vaccine and it is more of an inflammation rather than a infection.  The reaction has slowly subsided but the back side of my left arm is still a little swollen. The area is taking some time to get back to its normal size and appearnace. I continued to take the Cephalexin that I started. I was prescribed to take it 4x/day for 7 days.
Severe Fatigue and muscle pain, I had COVID 19 so it felt like a milder case for one day
Information has been received from a 48 year old female registered nurse with no pertinent medical history or allergies who was inadvertently vaccinated on 19-SEP-2000 with a one time dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (lot # reported as "4903") while preparing for an employment physical. There was no concomitant medication. Within 24-48 hours, approximately 20-SEP-2000, of the vaccination, the nurse noticed she had begun to stumble while walking. "It was like I wasn't able to roll of my toes any longer." The nurse stated that she was later found face down on the floor of her hotel room. She was sent home to from one city to another and was admitted to the hospital for dehydration. She was discharged and her condition continued to decline to the point where she could not walk. She stated that she was told she had "irreversible nerve damage from the neck down." On 22-APR-2002 she had unspecified "titers" done which were 374. In August 2003, the nurse was admitted to a nursing home/rehabilitation facility where she learned to walk again. She was discharged from the facility in May 2004. The then had to stay with her sister "for some time and continue to rehab." The nurse stated that she currently has to use a walker to ambulate. She stated that she has "tingling in her fingers and toes, like my hands are asleep. I only have deep feeling. When someone gives me a shot, I can't feel it, but I know they're pulling my skin." She stated the nerve damage "feels like I'm wearing a tight body suit." She stated follow-up information may come from her primary physician, who did not administer the vaccination. Began to stumble while walking, dehydration, could not walk, irreversible nerve damage from the neck down, tingling in her fingers and toes and hands are asleep were considered to be disabling. Additional information has been requested.
Pt developed varicella 2/11/07 despite receiving Varivax 7/20/06, no NO way known contacted varicella or Zoster.
Patient thinks her heart issues that developed approximately 4 months after her second moderna vaccine could be related. Her heart issues, which began approximately 8/30/21 include her gaining approximately 85 extra pounds in just excess fluid, developing a heart flutter, shortness of breath, easily fatigued and loss of appetite. Patient developed these symptoms and was having a hard time doing daily activities, patient then proceeded to the hospital, 10/1 to 10/9 of 2021. She had a seriously increased heart rate of 156 when she checked in. After checking out of the hospital she still has elevated resting heart rates, typically 90/95 BPM. Patient said she had absolutely no prior heart issues prior to receiving the Moderna Vaccines.
administration of Boostrix to a 16 month-old male patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 03-NOV-2024) for prophylaxis.   On 12-MAY-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Boostrix to a 16 month-old male patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-MAY-2023. It was reported a nurse called in to report the administration of Boostrix to a 16 month-old male patient which led to inappropriate age at vaccine administration The HCP asked for safety information regarding this situation. The reporter did consent to follow up.
Her husband on Monday came back positive with covid/Her 17 year old daughter is also in the house was also vaccinated; This is a spontaneous report from a contactable consumer (parent). A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient's father was tested positive with COVID-19 and the patient was also in the house. The clinical outcome of the event was reported unknown.  Information about lot/batch number is requested.
pt recv vax 4SEP96 & same noc pt devel raised, red rash patches on anterior forearm;