chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced an allergic reaction after getting the second dose of the Pfizer BioNtech COVID-19 vaccine; Chest pain; Dizziness; Rashes/rash is better in some places and has went away and then the rash comes back in other places; Lips are swelling; Hands are swelling; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (Patient's mother) or other non hcp. A 17-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0177, Pfizer NTEC), via an unspecified route of administration on 06Jun2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Lot: ER8736) on 16May2020 (at the age of 17-yesr-old) via an unspecified route of administration for COVID-19 immunisation. On unknown date, the patient experienced an allergic reaction after getting the second dose of the Pfizer BioNtech COVID-19 vaccine. Mother stated that the son started experiencing chest pain, dizziness, and as of yesterday he has been experiencing rashes, but after taking Benadryl the rash healed, and now his lips and hands are swelling. Mother clarified that her son's rash has not healed completely from the Benadryl, but it has made the rash better in some places it has went away and then the rash comes back in other places, like it is moving around. Caller clarified that the reason she was calling was to find out if this reaction to the vaccine was normal or if her son should be seen. The caller stated that she could not tell if it was the letter R or D but she thinks that it was the letter R. Caller requested a transfer for Medical Information, so limited information was able to be obtained for the report. No further details were obtained or provided for the report. Therapeutic measures were taken as Benadryl for rash. The outcome of the events was reported as unknown.  Description of Product Complaint: Caller reporting an AE on the Pfizer BioNTech COVID-19 Vaccine. She mentioned her son had a rash and used Benadryl. Her son's rash has not healed completely from the Benadryl, but it has made the rash better in some places it has went away and then the rash comes back in other places, like it was moving around.  No further information obtained, due to caller requesting MI transfer.
I stated having a small tickle in my throat so I decided to take a home COVID-19 Test that came back positive. I went to my local testing sight and had a PCR COVID-19 Test that came back positive, I went back two more times because I just couldn't shake this. I had a bad taste in my mouth and kept smelling this horrible smell. My doctor diagnosed me with acute sinusitis and prescribed me antibiotics.
Left arm numbness and pain post injection, post 2nd Pfizer injection.   Felt very tired and fatigue. No chest pain or SOB or cough or rash or edema. Was given Loratadine 10 mg x 1 by another health-care provider at the clinic.   Felt Fine Saturday April 24/2021.  On Sunday April 25/2021, really tired and fatigue still. Did report a fever of 102 F on Sunday evening.
At noon April 7 2021 I could walk up my stairs.  At 3:00 PM same day I could not walk up my stairs without pulling  myself up  with the help of my  banister.    Next morning so fatigued I needed I needed an energy drink to stay awake enough to read or watch TV. Am seeing cardiologist, both a neuo Dr and a neuro surgeon, rheumatologist, and  hemotologist.  10 months later I am stronger  and less fatigued, but I am not back to normal (March 2021).
Slept all day, was hard to wake. Fever started creeping up, then started crying inconsolably for hours upon hours. He was finally admitted on 3/4/2010.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 07-MAR-2019, the patient was vaccinated with improperly stored GARDASIL 9 (via intramuscular, lot #: R020948, expiration date: 04-MAY-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The GARDASIL 9 was exposed to 31.6 degree Fahrenheit for 40 minutes and 47.8 degree Fahrenheit for 20 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA006961: US-009507513-1903USA006952: US-009507513-1903USA006953: US-009507513-1903USA006954: US-009507513-1903USA006955: US-009507513-1903USA006956: US-009507513-1903USA006957: US-009507513-1903USA006958: US-009507513-1903USA006959: US-009507513-1903USA006960: US-009507513-1903USA006285.
My arm pain was significant enough that I could not sleep that night. I kept waking up.  The next day my arm was still in a great amount of pain. I had taken so me BC powder and Tylenol. It wore down when I applied ice to my shoulder.
pt recv vax & 2 days later devel an inc in bilirubin levels;bilirubin levels subsequently returned to nl;
Dtap/IPV/HIB Pentacel vaccine was expired when it was administered to patient. Vaccine expired on May 22, 2021.  No adverse event occurred to patient
Pt received the second dose of Varicella vaccine within the first 15 minutes after receiving the second dose she began to feel dizzy and nauseous and began to develop urticaria on face, neck and chest. Denies SOB, denies difficulty breathing or swallowing. Vitals were stable  25mg Benadryl was given orally STAT(1437). 10 minutes later she reported a headache with 4/10 pain and a throbbing feeling in her Right Arm, she was given ice for her arm and drip drop. aprox 1545 pt stated she was feeling better.
Information has been received from a physician through a pregnancy registry concerning a 14 year old female who on 11/19/04 was vaccinated with a dose of varicella virus vaccine live. The physician believes that the patient conceived on 11/20/04. LMP was approximately 10/29/04 and the patient's EDD 8/7/05. Unspecified medical attention was sought. At the time of this report, there was no information provided about the present status of the patient. No product quality complaint was involved. Follow up information was received from the physician containing outcome information about the 14 year old patient. It was reported that the patient gave birth to a normal live born infant on 8/1/05, 38 weeks from LMP. The birth was by cesarean section for fetal distress. It was also reported that the patient had routine prenatal diagnostic testing, including an ultrasound on 3/23/05 which was WNL. Also noted was that the patient had one previous pregnancy and one previous full-term birth. Upon internal review, the fetal distress was determined to be an other important medical event (OMIC). Additional information is not expected.
The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 16 September 2013. An adult patient had received 0.24 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Five hrs post vas, pt devel h/a, dizziness, nausea, & left work; Next day devel markedly elevated temp, swelling of hand & feet, dyspnea, slow heart rate; rxn lasted nine days;
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date at 0.5 ml, single. The patient medical history and concomitant medications were not reported. The patient experienced celiac disease and abdominal pain on an unspecified date. The outcome of the reported events was unknown at the time of this report. The reporting pharmacist questioned about the ingredients of PREVNAR 13.
Patient received 1st dose injection approximately 4:40pm. Patient fainted after administration. Supportive care provided. Patient was feeling better a few minutes later. After 15 minute monitoring period patient left with guardian. Guardian called in to pharmacy approximately 1 hour post injection and stated that patient was feeling weird (difficulty swallowing and shaky). Guardian indicated no difficulty in breathing and no increase in respiration. Guardian was to continue monitoring for worsening symptoms. Symptoms worsened a few minutes post phone call and patient was taken by ambulance to hospital for treatment.
Left sided facial numbness, I got an mri on my head and on my neck to rule out cancers, ms, etc, my neurologist said it is nothing structural causing the numbness and that it is sensory issues and due to the vaccine. I have not had any head injuries and nothing wrong with my brain scan.
Shaking hands, leg weakness, head ache, night sweats, stomach pain and upset, unusual bowel movements, gas, burping, TSH CHANGE, WEIGHT LOSS.
When the first shot was given to my daughter on 11/22/06, she started feeling short of breath, had a hard time swallowing & had an iron taste in her mouth. They Doctor was notified & they monitored her for 30 minutes to see if the symptoms would worsen. The symptoms slowly went away & they noted the reaction in her chart. When she had the 2nd shot on 2/16/07 she had the same symptoms but not as severe, her biggest complaint was the iron taste in her mouth. Again she was monitored for 20 minutes until the symptoms went away. She had the last of the shots on 7/27/07 & again had the iron taste in her mouth & the trouble swallowing but no shortness of breath. She was monitored for 20 minutes until the symptoms went away. Also on all 3 occasions about 10 to 15 minutes after the shot was administered she came down with a headache. The last shot's headache was the worst one, the headache lasted her most of the rest of that day & was more severe.
This case was reported by a Other Health Professional via sales rep and described the occurrence of headache in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis and Flu Seasonal TIV Quebec (Flulaval) for prophylaxis. Concomitant products included Men ACWY-CRM NVS (Menveo), Men B NVS (Bexsero) and Flu Seasonal TIV Quebec (Flulaval). On an unknown date, the patient received the 2nd dose of Menveo, the 2nd dose of Bexsero, Meningococcal B Vaccine Pre-Filled Syringe Device and the 2nd dose of Flulaval. On an unknown date, unknown after receiving Menveo, Bexsero, Meningococcal B Vaccine Pre-Filled Syringe Device and Flulaval, the patient experienced headache, drug dose administration interval too short and extra dose administered. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the drug dose administration interval too short and extra dose administered were unknown. It was unknown if the reporter considered the headache to be related to Menveo, Bexsero, Meningococcal B Vaccine Pre-Filled Syringe Device and Flulaval. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was not reported. The patient was given 1st dose of Menveo, Bexsero and Flulaval then 6 weeks later was administered another dose of each Menveo, Bexsero and Flulaval. The patient received 2nd dose of Menveo early than recommended which led to shortening of vaccination schedule. The patient received 2nd dose of Flulaval, which led to extra dose administration. The patient had ongoing headaches for weeks after 2nd administration. The reporter consented to follow up.
No additional adverse event; Nurse called to inquire about the need for VAQTA revaccination for a 5 year-old female patient. According to Nurse, Patient is coming to HCP office today, 10JUL2023 for vaccinations, and their EMR alerted them that the patient requires a second dose; This spontaneous report was received from a nurse and refers to a 5-year-old female patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 24-SEP-2018 at age of 1 year old, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and anatomical site of injection were not provided) and received the second dose of hepatitis a vaccine, inactivated (VAQTA) on 13-MAR-2019 as prophylaxis (strength, dose, lot #, expiry date, and anatomical site of injection were not provided) (11 days earlier than recommended dosage interval of 6 months between first and second dose) (inappropriate schedule of product administered). The nurse was inquired if the patient needed a re-vaccination. No additional adverse events.
My liver enzyme level have increased to upward of 4 times the normal level since receiving my 5th dose of Moderna. I did have increased levels before this dose but never this high, so I had to see my hepatologist in regard to these elevated levels. The reason I knew they were elevated was due to the required blood work that I have done due to a medication that I'm on for other things.  When I had the appointment with my hepatologist, she consulted with her attending doctor who advised that I would need another liver biopsy but a trans jugular biopsy and also a hepatic venography. In addition to my elevated liver enzymes, the doctor ordered blood work to see if I have an auto immune liver disease. The blood work came back positive for an auto immune disease that I do not already have and they are currently trying to figure out what exactly it is.
Allergies: Pneumococcal Vaccine - Hives,Swelling; Swelling; Hives; This is a spontaneous report from a contactable physician.  A 56-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: pneumococcal vaccine - hives, swelling on an unspecified date with outcome of unknown.   Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.
The patient mentioned having slight light-headedness immediately after the vaccination was given, which was followed by temporary loss of consciousness about 2 minutes after administration.  He regained consciousness within a minute.  He had fallen to the floor, where we laid him out with his head slightly elevated on a bag of rice.  His pulse was detected during the initial response following syncope.  His face had a pale complexion and his body had tensed up before he became responsive again.  We allowed the patient to continue to lie down until he felt better.  We slowly sat him up on the floor and slowly helped him to a nearby chair, which was about 15 minutes following syncope.  Within a couple of minutes, patient stated feeling light-headed again, so we slowly moved him back down to the floor to lie down again.  He rested there for approximately 20 minutes, then we helped him to the chair to sit again.  The patient was offered water and a snack bar.  He sipped on the water a couple of times while seated in the chair.  The patient was stable enough to leave the pharmacy about an hour after vaccination administration.  EMS was called when the incident occurred, but the patient refused to have them come to the pharmacy to check on him.  The day after the incident, the patient stated having a headache and feeling a little tired.  But, overall, he is doing fine.
Patient presents with bilateral lower extremity redness/swelling in addition to itchy skin and eyes that began approximately an hour after she had a live zoster vaccine injection. Patient denies any associated chest pain or difficulty breathing. Denies any fevers. ER treatment included Benadryl and dexamethasone IM. Beginning 6/21 AM, take prednisone 40mg once a day for next 3 days.
During 15 minutes post-monitoring period: Patient complained of facial itching, lip swelling, throat itching/tightness   Gave 50 mg Benadryl PO 945 am  Pulse ox at this time as 98% Still c/o worsening swelling of throat Patient administered her own EPI pen 950am Called 911 OMD advised and came to assist Pulse ox dropped 88% Administered 2L NC went up to 98% Heart rate 130 after EPI pen EMS arrived and took over
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The nurse stated that the patient who previously received a Hepatitis B series showed a non reactive titer to a recent blood test, which led to therapy non-responder. Lab Comments: On an unknown date hepatitis B antibody was measured.
Vital signs: Blood pressure: 105/63, temperature 98.4. Increased redness to bilateral upper legs. Increased swelling to injection sites. Skin intact. Areas tneder to touch. Denies pain.
Swollen hands,numbness, pain in fingers & wrist aching, weakness, difficulty turning on or holding phone. At night hands fall asleep & splints worn for 2 wks & 2 days. Dx Carpal Tunnel synd. middle finger still numb.
Patient was initially administered only half dose (0.25 milliliters) of the recommended (0.5 milliliters) moderna bivalent dose. Approximately 6 hours later, the additional 0.25milliliters was administered. No adverse reactions reported.
First dose on 21Mar2021, second dose on 05Apr2021; heart pain; Headache; Pain in my chest like left side of my chest; My body started to ache; My arm aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE; CONCERTA; FINASTERIDE. Vaccination history included: Bnt162b2 (first dose), administration date: 21Mar2021, when the patient was 18 years old, for COVID-19 immunization, reaction(s): "little swelling in the arm". The following information was reported: ANGINA PECTORIS (medically significant) with onset Apr2021, outcome "unknown", described as "heart pain"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "Headache"; CHEST PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Pain in my chest like left side of my chest"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "My body started to ache"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "My arm aching"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Apr2021, outcome "unknown", described as "First dose on 21Mar2021, second dose on 05Apr2021". Therapeutic measures were not taken as a result of angina pectoris, headache, chest pain, pain, pain in extremity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated,  BP dropped, HR wnl, After about 20 mins, I felt fine.  Went to work, did develop a migraine afterwards, some body ache and fatigue.
Approximately 1 1/2 hours after injection, severe pain in left shoulder. Injection was given very high-into my shoulder. It has been 16 days and I still have serious pain in my left shoulder. I have never had trouble with either shoulder previously..
Sharp shooting pain in head above temple. Intermittent symptoms for 1 week. Arthritis flare up in hands and muscle weakness in arms and legs. Low grade fever 5 days after injection of high dose FLUZONE.
patient inquired, could they go ahead and get the Twinrix vaccine because it contains both the Hep A and Hep B components to count as the Havrix portion and to start the Hep B series.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received HAV (Havrix adult) for prophylaxis.   Previously administered products included Havrix adult (1st dose received in 2015).   On an unknown date, the patient did not receive the 2nd dose of Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced incomplete course of vaccination (Verbatim: patient inquired, could they go ahead and get the Twinrix vaccine because it contains both the Hep A and Hep B components to count as the Havrix portion and to start the Hep B series.). The outcome of the incomplete course of vaccination 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:24-AUG-2023 Pharmacist called to inquire the how to proceed. Do we need to restart the whole series of Havrix Or can the patient get the Twinrix vaccine to have the combo Hep A and Hep B. RPH stated the Adult patient received the first dose of Havrix back in 2015 and came back to complete the Havrix series. But the patient inquired, could they go ahead and get the Twinrix vaccine because it contains both the Hep A and Hep B components to count as the Havrix portion and to start the Hep B series. At the time of call, Havrix and Twinrix has not been administered, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Employee received the vaccine on 9/7/2023, reports feeling symptoms on 9/9/23. Describes symptoms of bilateral arm & leg weakness, tingling bilateral wrists, severe migraine & nausea that started on 9/12/23. Nausea is persistent, has a loss of appetite. Employee presented to Employee Health office 9/14/23 after appointment with occupational medicine made 9/14/23.
Right after the dose I got an immediate headache, dizzy and light headed. About an hour later I became nauseous and my face became very flush red and hot. I went to bed and woke up feeling like I got hit by a truck and was very tired with a sore arm. By the next day I was better. The following week I began with a red hot circle on my arm where the shot was given, it had a ring around it. That lasted for about a week. I then started to get stinging sensations in that part of my arm like I was being stung by a bee. These lasted for about 2 days. I then started getting muscle rolls/spasms in the same spot on that arm. They lasted about 3 days. I then started having pain in that arm like I had just gotten the shot and as I was rubbing it, I noticed a large indent in my arm. I went to the doctor, and they said they had no idea why it happened but if I get more symptoms to come back. The doc appt was on 4/12/21. It has been over a month of these side effects. Doctor not sure if it will be a permanent disfigure.