chrisvoncsefalvay/vaers-outcomes huggingface dataset:
of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; of low grade fever, pain at injection site and malaise on the first few days. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia; This is a spontaneous report from a contactable physician. A 61 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown since misplaced/discarded) via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. The patient had dengue fever in 2018. The patient concomitant medications were not reported. Caller requested information for her husband who received the Covid 19 vaccine. Vaccine recipient was "asymptomatic" with a report of low grade fever, pain at injection site and malaise on the first few days in 2020. On day 7 through day 10, recipient reports a high fever of 101.8 and severe myalgia. Caller stated her husband tested negative for Covid, flu and rsv post vaccination and blood work comes back good in 2020. Caller wanted to know if her husband should get the second dose of the Covid 19 vaccination.   Information on the Batch/Lot number has been requested.
Patient took 1st pill on 2/23/06, 2nd pill 2/25/06, at 2pm 2/26/06 developed hives all over body with difficulty breathing, took BENADRYL. Saw PMD on 2/27/06, rash and breathing problems gone. D/C last 2 doses.
dragging her arm around / unable to move her right arm back to put a jacket on; could not sleep due to this arm pain; injection site pain in her right arm never resolved / getting worse; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th February 2021, the patient experienced insomnia. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the insomnia and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, insomnia and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient reported injection site pain in her right arm never resolved and was  now getting worse. The patient was dragging her arm around. Last night from day of reporting she could not sleep due to this arm pain and she was trying to massage her arm. She was unable to move her right arm back to put a jacket on.  Reporter did not consent to follow up.
Administration Error: Immunocompromised Female patient 23 years old, receives as a third dose booster dose of 0.25ML due to omission of information by the patient at the time of interview.
This spontaneous report was received from a Licensed Practical Nurse refers to a 17 year old Hispanic female patient. There was no information about patient's pertinent medical history reported and concurrent conditions. No concomitant medications were reported. On 12-APR-2017 at 9:37 am, the patient was vaccinated with improperly stored dose 2 of VARIVAX (lot # M037642) via subcutaneous route in the left arm, for prophylaxis. She received the first vaccine dose on an unknown date.    This is one of three reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002753: US-009507513-1706USA002207:
When I went to sleep on 1/19/10, my left shoulder, where the Boostrix and Polio booster were injected, was really sore. When I woke up on 1/20, my stomach ached, so I prepared a bowl of cheerios with rice milk and bananas. About 5 bites in, my body told me to stop eating. I couldn't tell if I was going to faint or if I was nauseous, so I headed for the restroom. When I got there I had to sit down on the side of the bathtub because I couldn't stand up. For about 5 minutes I found myself in a cold sweat, dizzy, and unable stand. After 5 minutes, I was able to stand and went back to bed. I took my temperature, which was 99.8 degrees F, and noticed my body ached. Throughout the day my temperature yo-yo'd from 99.5 up to 100.8 F and down again. My stomach continued to have an achy, burning feeling, my head ached, I had little to no appetite, and I slept a lot. I was not nauseous, nor did I have any respiratory symptoms, except that my abdomen hurt when I breathed. I think this is more related to the stomach pain. Today is 1/21/10, and the total-body aching has subsided a lot, but I still remain fatigued, have little appetite, my stomach and head still ache, and my temperature has fluctuated from 99.1 to 100.1 F. I have had to take 2 sick days because I do not feel well enough to work.
Uncontrollable crying all night until 7:30 AM with no fever, then at 3:00 PM on 4/12/05 had a fever of 103.
This spontaneous report as received on 06-MAR-2017 from a female pharmacist, refers to multiple unknown patients (age and gender unknown) who on unknown dates were administered M-M-R II for prophylaxis. The patients' pertinent medical history, concomitant medications and drug allergies were not reported. The pharmacist reported that multiple unknown patients have been administered MMRII that "has been stored in the tube system for approximately 1 hour then administered by the nurse" on multiple unknown dates. No adverse effects reported. No further information was reported. Additional information has been requested.
patient lost consciousness at about 1038 am, I laid him down on the floor called ems, he came to I had him rest for a few minutes and sat him up, gave him some water he stated he had not had anything to eat that morning EBS cam took vitals and released him. he said he felt fine waled around the store for a few minutes and drove himself home. I told him if he had any other problems to call 911
Redness, swelling and warm to the touch (no pain) below injection site on left arm. Iced several times/day the 18th, 19th, and 20th. Marked improvement April 21, 2021.
After receiving the PPV23 shot I have symptoms of Left arm pain around the Left shoulder joint. Limited range of motion in left shoulder. Constant shooting pain up left arm. Tingling sensation in the fingers of the left hand.
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 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Lumbar/cervical stenosis" (unspecified if ongoing); "factor V Leiden" (unspecified if ongoing); "history of DVT/PE" (unspecified if ongoing); "history of DVT/PE" (unspecified if ongoing); "narrowing of spinal cord" (unspecified if ongoing), notes: narrowing of spinal cord. Concomitant medication(s) included: DULOXETINE; WARFARIN. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine"; Rocephin, reaction(s): "KNown allergies: Recephin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Normal; Heart rate: (20Jul2022) 100, notes: going up to 140 simply walking 20 yards; Oxygen saturation: (10Jul2022) 88-89; (20Jul2022) 88-92. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was suddenly exhausted and after about two hours, she began to notice congestion (which she did not have during the time she was taking Paxlovid), muscle aches, and joint pain. The doctor prescribed another round of Paxlovod, but after personal research, she decided against taking it. On July 10th, she went to the emergency room because she had chest pain, tightness, and my oxygen was 88-89. she had a CT scan and crays and both were normal, so she was sent home with instructions to follow up with her doctor. To date, she was still experiencing low 02 (88-92), extreme fatigue, and a resting heart rate over 100, going up to 140 simply walking 20 yards. Patient recovered with lasting effects and the treatment was received such as steroids, antibiotics, albuterol nebulizer and inhaler.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Bells Palsy of left side of face developed starting the day after shot #2 and getting worse over the course of a week
Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 07:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 13Nov2021. Vaccination history included: Bnt162b2 (dose 1 (tris), single, administration time=07:00, vaccine location=Left arm, lot number=FK5127), administration date: 08Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 01Dec2021 07:00, outcome "recovering", described as "Vomiting". The event "vomiting" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vomiting.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 48 hours after vaccination child was vomiting. Doctor prescribed nausea meds as treatment for the adverse event.  No follow-up attempts are possible. No further information is expected.
I did not have a reaction to the vaccine. On 12/06/2022, I began not feeling well with a cough, congestion and nasal drainage. As the day progressed my symptoms got worse, so I tested for COVID-19 with a home test, and it was positive.   I contacted my doctor by telehealth visit and was give the prescription Paxlovid.
ACTHIB reconstituted with 0.9%NaCl; Initial information received on 18-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health care professional via call center.  This case involves a 12 months old male patient who reported acthib reconstituted with 0.9%nacl while receiving vaccine Hib (Prp/T) Vaccine [Act-Hib].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included  (Hepatitis Vaccines) for Prophylactic vaccination; Varicella Zoster Vaccine (Varicella Vaccine) for Prophylactic vaccination; and Pneumococcal Vaccine Polysacch 23V (Pneumovax) for Prophylactic vaccination.  On 17-Mar-2022, the patient received a  dose of suspect Hib (Prp/T) Vaccine at dose of 0.5ml (formulation and strength: unknown)(lot number: UJ524AA and expiry date: unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 17-Mar-2022, the patient reported a Act-hib reconstituted with 0.9%nacl (product preparation error) following the administration of Hib (Prp/T) Vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product preparation error.    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.
Initial report was received on 22 October 2010 and 26 October 2010 from a health care professional. A cluster of four unidentified male and female mixed patients "over the age of 65", had received FLUZONE HIGH-DOSE No Preservative 2010-2011 (lot number, date, route and site of administration not reported) and an unspecified amount of time later they experience chest tightness, chest pain and shortness of breath. All four patients were evaluated in the emergency room to rule out cardiac problems due to age. One patient was hospitalized, but it was determined that the patient had gastric issues that were causing the symptoms. It was reported that none of the other three patients were hospitalized. Treatments were not provided. No further information was available at the time of the report. The patients' outcomes were not reported. Documents held by sender: none
I95.9 HYPOTENSION 4/15/2023 PNEUMONIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/21/2023 PNEUMONIA R09.02 HYPOXIA 4/15/2023 PNEUMONIA
Fever, fatigue, headache,lung congestion,eye pain,hand and feet pain(cramps needle/pins poking)eyes blurred,sleepness
48 year old man recieved pfizer vaccine at 9:45am and began experiencing symptoms at 9:48am. Pt presented diaphoretic with drool dribbling from his mouth with eyes rolling back, staring straight up with beats of horizontal nystagmus slumping in his chair. Pt did not respond to verbal or tactile stimuli. This episode lasted ~20 seconds. After this episode pt was AOx3 with eyes open. Pulse remained regular throughout the entire encounter. Denies: SOB, CP / dyspnea, HA, N/V, trauma, numbness, tingling, erythema. EMS was called to monitor vitals. Pt was transported via EMS to hospital (as per patients request), pt agreed to be transported. EKG was unable to be obtained due to chest hair.    PMH: HTN, hyperlipidemia PMH: HTN, hyperlipidemia, Anxiety Meds: amlodipine, metoprolol, simvastatin, remapril, pepcid, lexapro Allergies: Penicillin (rash)   Patient was advised for second dose of Pfizer to request to be laying down while getting the vaccine in case of a repeat episode or vasovagal risk.
Went to bed chills; Fever 101.7; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient went to bed with chills, treated with paracetamol (TYLENOL) and also experienced fever 101.7; both on an unspecified date. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
Information has been received from a healthcare worker concerning a 10 year old female who on  10/9/04 was vaccinated with MMR (lot # 647648/0318P). Subsequently, the patient had difficulty breathing and turned blue. The physician administered nebulization and epinephrine. The patient was taken to the hospital by ambulance and was shortly released. The patient was reportedly doing well. It was reported that the office manager said that this must be a bad batch of MMR and should be removed. Upon internal review, difficulty breathing and turned blue were considered to be other medical events (OMIC). It was also reported that another patient had an adverse event (WAES0410USA02277). Additional information has been requested.
The day after the shot I had a swollen lymph node in my left armpit. I also had a rapid heartbeat and didn't  feel well. Three days after that, from Wednesday  thru Saturday, I developed crushing chest pain and thought I was having a heart attack. I was unable to work or do anything. The pain was felt in my extremities as well, fingers and toes. I also had a migraine, and pain in my jaw and teeth, lots of fatigue.  I still have not recovered 100% and continue to experience slight  chest pain randomly.
**NOTE: Medication error without adverse drug reaction. No harm to the patient.   A patient who should have received the full 0.5mL dose of Moderna received the booster dose of 0.25mL.
First shot I got a giant red rash 7 days after on my arm.; This is a spontaneous report from a contactable consumer (patient herself ). A 36-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on unspecified date as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia, asthma. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient is not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. After the First shot she got a giant red rash 7 days after on my arm. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 09Mar2021. The patient visited physician office. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
PATIENT SAID SHE WOKE UP AT 3 AM ITCHING ALL OVER HER BODY, HAD SPOTS EVERY WHERE AND BURNING PAIN ON BOTH LEGS AND FEET. I TOLD HER TO TAKE A BENADRYL AND GO TO URGENT CARE OR SEE HER PCP AS SOON AS POSSIBLE. SHE SAID ONE LEG STARTED TO GET BETTER BUT THE OTHER LEG STILL HAS SPOTS. SHE WILL CALL HER DR ON MONDAY WHEN THE OFFICE IS OPEN.
Did not have any anaphylactic reactions, or other reactions. Patient received Moderna and  is under 18 years old.
2nd dose greater than a year?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter asked for if 2nd dose greater than a year, which led to incomplete course of vaccination.
On 9/28/2022, I tested positive for COVID-19 via a Binax hometest.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Medium
Information has been received from a nurse concerning a 9-year-old female patient who on 30-AUG-2008 received the second dose of 0.5ml VARIVAX (Merck) (lot # 658176/1011U) via subcutaneous route in her left arm. Subsequently, the patient developed "two ruddy discolored patches" with uneven borders which were not elevated above the injection site. The patient came to the office to seek medical attention on 02-SEP-2008 with "two ruddy discolored patches" still presented. At the time of reporting, the patient was not recovered. The patient received the first dose of VARIVAX (Merck) on 19-APR-2008. Additional information has been requested.
Information has been received from a physician concerning a 73 year old female with no medical history and penicillin allergy who on 16-APR-2007 was vaccinated SC on right arm with a single dose of Zostavax (Oka/Merck) (Lot 3 656412/1476F). Concomitant therapy included 10mg/20 mg once daily ezetimibe (+) simvastatin (MSD). On 05-OCT-2007 the patient developed shingles on her "bottom" which was described very painful to sit. The patient was prescribed valacyclovir hydrochloride (VALTREX), prednisone and hydrocodone for her symptoms. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. The patient's experience was considered to be disabling by the reporter. Additional information has been requested.
3Sep07 pt received 3rd anthrax. Oct 5, 07 pt had bulging left eye with puffy upper and lower lid and severe left eye pain. The eyelid puffiness resolved in one week. The bulging left eye decreased in one week and resolved in one month. Pain was constant until Jan09. On Oct 7, 07 pt had total body tremors which lasted about one hour--no LOC, no loss of bowel/bladder control. No SOB, pt was nauseated. BP was high when checked. Continues with intermittent tremors in hands and left leg. Oct 26, 2007 pt had substernal chest pain/pressure (8/10), left arm and bilateral leg tremors, pain left shoulder, radiating to the left arm and left fingers. Pt states her fingers were red. Pt also had "tightness in left side of neck". Oct 31, 2007 pt started with frontal headache. Pt continues with intermittent left eye pain, headaches, chest pain, left arm pain. Symptoms can occur with rest or activity.
dev.  vomiting and diarrhea within 48 days after admin. of 2nd ROTAVIRUS  vaccine at 4 mos well check on 11/07/08.   Was tx at hospital ER, with IV fluids and ZOFRAN
The same day I had swelling in my right shoulder I went into the clinic and they said it was normal..today I have tingling in my fingers there is a noticeable lump on my right shoulder and I am having severe pain. I went into the office again today and he said it's all in my head. The right side of my upper body is swollen (shoulder & collar bone) my fingers are tingling I am unable to hold a piece of bread in my right hand. SOMETHING IS VERY VERY WRONG WITH ME AND IT IS NOT AN IMAGINATION.
Pt post (covid) vaccination felt warm/dizzy. reclined in medical tent, gave h20 v/s felt better, released. Moderna 047a21a 12:20 136/113 p88 r20 12:32 122/76 p84 r16
3 hours after receiving vaccine, pt. became ill, tired, dizzy. Pt. did not feel like himself. Pt. was unable to maintain a conversation. Pt. was in bed for 24hr, not eating. Reaction lasted 36-48 hr. Full recovery.
pt devel a fever of 105 on 17APR93; taken to ER, given a tepid bath & APAP suppository; examined by ER MD & sent home; fever returned to 104; pt seen in MD office 19APR93 dx OM;