chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Injection site pain; headache; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Historical vaccine included BNT162B2, first dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain, headache and body aches. The clinical outcome of events was unknown.  Information about lot/batch number requested.
8 days after vaccine I had a shingle like reaction at the injection site that lasted 24 hours before becoming just a regular rash. I took a picture. Also some muscle pain in my left thigh & calf that lasted a few days.
Got YF shot on the 26th. About PM of 5/30 both patients had a rash on YF site. One patient's was smaller but more sore. Other patient's was larger but did not hurt. Both had an ADACEL shot on that arm 5/29.
Patient experienced tingling in hands and anxiety after first dose of COVID 19 Vaccine (Pfizer). Patient was monitored for 30 minutes and did not require medical treatment.
Left arm swelling after vaccines on 9/29/20, no pain, slightly sore, warm to touch
2 days after receiving vaccine, I am experiencing severe "ringing" in my ears. (Tinnitus)
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 18-year-old male patient who received BEXSERO. On 29th January 2018, the patient received the 1st dose of BEXSERO. On 29th January 2018, less than a day after receiving BEXSERO, the patient experienced influenza-like symptoms, chills and myalgia. On an unknown date, the outcome of the influenza-like symptoms, chills and myalgia were recovered/resolved. The reporter considered the influenza-like symptoms, chills and myalgia to be related to BEXSERO. Additional information was received as follows: This case was reported by the patient's mother. The case has been linked to the case US2018051277, reported for same patient. The case has been linked to the case US2018051278 and US2018GSK057910 (brother's case), reported by same reporter for the patient from same family.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R009409, expiry date 29-MAR-2020 (also reported as 31-OCT-2018) subcutaneously for prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14 F (9.3F) for 5 hours and 2 minutes. Previous temperature excursions were detected: 15 F to 46 F (41.5 F) for 84 hours. Digital data logger was involved. No adverse effects were reported.
Information has been received from doctor of pharmacy concerning a 73 year old female patient with an unspecified list of allergies to medications and other products, who on 30-SEP-2010 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck) (Lot # 665311/1310Y). The pharmacist stated that on 02-OCT-2010 the patient experienced swelling, itching, and redness at the injection side. At the time of the report, the patient had not recovered. There were not laboratories performed. The patient sought unspecified medical attention. Additional information has been requested.
patient developed a hot, red swollen area on here posterior lateral Right thigh 4 days after she received vaccines in that leg.  Of note clearly she only got 2 vaccines - but 3 were documented to have been on that side.  She was seen in the ER and diagnosed with an abscess, tx with clindamycin.   clinically improved.   however did have persistent nodule palpated there even after completion
Within a week of receiving a booster dose of C-19 vaccine, I developed severe diarrhea (>6 liquid stools/day) with abdominal cramping and flatulence. Based on biopsies collected via colonoscopy, I was diagnosed with "microscopic colitis" about a month later after numerous tests to rule out infectious causes. The symptoms are slowly resolving after 2 months on oral steroids and a limited diet.
Painful swelling at injection site. About 4 inches in diameter on 10/28. Hot to touch. On 10/29 swelling is starting to go down but is still over 2inches and remains hot and painful.
Initial information received from a healthcare professional (allergist) on 04 November 2013. An 11-year-old male patient received FLUZONE, lot # U472AA (not a valid Sanofi Pasteur lot number, to be confirmed) at a pediatrician's office (date, route, site and dosage of administration were not reported). The patient's mother reported the patient experienced shortness of breath, hives, and itchy and watery eyes after vaccination. The reporter saw the patient for a consult for "allergic reaction". Treatment details were not reported. The patient has a history of egg allergy in that if he eats eggs, he vomits. Further details were not available at the time of this report. The patient outcome is unknown. Documents held by sender: None. Follow-up information received from a healthcare professional on 02 December 2013: The patient had received fifth dose of FLUZONE vaccine, lot number: U4772AA, intramuscularly in left deltoid on 05 October 2013 at 9:30 hours. The patient had laceration at right knee at the time of vaccination. He had no adverse event following prior vaccination. The patient on his right knee had cut right knee. He developed laceration at right knee (2.5 cm) with 3 mm wide and 2 mm deep. The patient referred to urgent care for suturing and supportive care. He received EMLA cream that was applied to skin around laceration with occlusive dressing at 12:00. No concomitant medications were administered. The patient complained of scratchy throat. He had frequent dry hack. He had cough 30 min after flu shot. The patient had possible anxiety induced coughing episode. The patient received Albuterol 90 mcg, 2-4 puffs inhaler, 4-6 hrs prn for cough and tight chest. He was given ORAPRED 60 mg and BENADRYL 37.5 mg.
Headache, sinus congestion, productive cough, sore throat beginning 9/19/12 (night of administration).
Information has been received from a physician concerning a 13 year old patient who on 19-OCT-2010 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Merck) (Lot # not reported) instead of VARIVAX (Merck). No adverse symptoms were reported. Additional information has been requested.
PT SAYS HE STARTED HIS DAY BY WAKING UP AND FALLING HITTING HIS HEAD ON THE DRESSOR IN HIS BEDROOM. HE CHECKED HIS BLOOD PRESSURE RIGHT AFTER AND IT WAS 90/48. PT STILL CAME IN AND GOT VACCINATED AND FELT REALLY FAINT, PT LOOKED PAIL, AND HIS HANDS WERE COLD. BLOOD PRESSURE CHECKED WAS 78/42. HAD PT LEAN FORWARD, BUT COULD RAISE BLOOD PRESSURE FOR 30 MINUTES OF TRYING. ASKED PT IF HE WANTED AMBULANCE, HE FINALLY AGREED AFTER 30 MINUTES.
phlegm in throat; Headache; Dry cough; It just made her uncomfortable; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL1284), intramuscular on the left arm on 04Jan2021 15:01 (she would say 15:01 because they told her to wait 20 minutes after receiving the vaccine and she left at 15:21) at SINGLE DOSE for COVID-19 immunization. The patient stated that she might be a little obese. There were no concomitant medications. When she got the vaccine on Monday (04Jan2021), she felt okay. The next day, it seemed like she had phlegm in her throat. She also had a horrible cough and headache. She don't know if it's the vaccine or what. It was mentioned that the phlegm in her throat was no longer horrible went away by the same day of 05Jan2021. The patient also stated that she took two acetaminophen (TYLENOL) for the headache and it went away last night (05Jan2021). However, she has the headache again by 06Jan2021. It was also mentioned that her dry cough that just won't go away, it's persisting. She can't cough, because people don't like that- they get uncomfortable. The patient mentioned that she didn't see any of these side effects on the paper she was given. It just made her uncomfortable, she didn't know what was going on with her body. Outcome of the events of productive cough and headache (initial occurrence) were recovered in 05Jan2021; recovering from dry cough; not recovered for headache (recurrence) while unknown for the remaining event.
The night after the client received the Zostavax vaccine, she woke up at 4:30 - 5:00 AM with a swollen arm, difficulty breathing and a feeling her throat was swelling.  She took a benadryl and drank some water.  This episode lasted about 20 minutes, she began to feel better and went back to sleep. When she woke up on Wednesday morning about 2 hours later, she felt fine except for some slight swelling in her arm.  She wasn't sure if this was something she needed to tell us or not, and when someone mentioned she should call us and report it, she did.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dosing details were not reported). There were several previous temperature excursions. Time frame and temperature excursion were not reported, but the reporter stated that the temperatures the vaccine were exposed were above the range and the range was back. There were prior excursions reported. It was unknown if the call was due to data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Headache     started thursday  ? Chills ? Cough ? Nasal Congestion ? Generalized Body Aches
Patient visited local ER after shoulder pain resulting from flu immunization did not resolve in 1-2 days. MRI was performed at ER, patient was prescribed tramadol for pain on 9/4. I followed up with the patient on 9/7 and she stated the shoulder pain had resolved.
Vaccine administered at 11:30, patient had unexpected syncopal episode resulting in head trauma with laceration to mid left forehead, patient kept on floor in recovery position sterile gauze applied with ice, brief neuro assessment by NP EMS notified at 11:35, while waiting for EMS mild pressure applied to head wound. EMS arrived at 12:10 and brief report given; EMS performed brief Neuro assessment and transported patient to hospital for treatment.
When she received injection it hurt her arm. She came in a few days after and complained of arm to sore to lift above shoulder. Then she came back and complained of also having tingling in arm.
7/13/05; R arm 15 x 10cm red , swollen and tender.
swelling and redness to left thigh 2 days after shots no treatment needed use ice and advil for pain
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 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Lot number: EL9269), on 21Feb2021 as dose 2, single (Lot number: EL9269), on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 18May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "Limited Scleroderma" (unspecified if ongoing), notes: Limited Scleroderma; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LEVOTHYROXINE, start date: Nov2010. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: days after negative test 1 week after completion of treatment I tested positive; (Sep2022) Negative, notes: Tested negative 3 days after Paxlovid completed. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patients father who is a Pediatric Physician  wrote the incorrect birth date on the consent, the error was not caught and the 4 year old received the Vaccine meant for 5-12 year olds.  The father was contacted and he stated the child had no adverse reactions to the vaccine.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt was instructed to lay flat during injection administration due to him saying he has once fainted but it was a long time ago. However, pt sat up after vaccine without resting and said he no longer needed to lay down. Once he was sitting in the clinic chair, LVN noticed pt was pale, clammy and was in and out of consciousness. Pt had a vasovagal response after vaccine administration. NP was notified immediately. EMS was activated. Pt was stable after 15 mins. No harm or falls in clinic.
Red circle; raised welt at injection site bigger than original mark. Painful bruise feeling, like the original shot, for 3 days, then just itchy and tender for 17 days.
100 - 102.3 degree Fever starting at 11 PM day of vaccination and continuing until 6 PM next day. severe chills for approximately 3 hours from 11 PM to 2 AM on day of vaccination (04/15/2021). Headache and body aches starting at 11 PM day of vaccination and continuing until 6 PM next day. Took 1000 mg of Tylenol at 1 AM on day following vaccination (04/16/2021)  to treat fever and headache
the administration of Boostrix instead of Infanrix to a 17 month old female patient; 17 month old patient recevied Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10-NOV-2024) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: the administration of Boostrix instead of Infanrix to a 17 month old female patient) and inappropriate age at vaccine administration (Verbatim: 17 month old patient recevied Boostrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 14-AUG-2023 The reporter stated the administration of Boostrix instead of Infanrix to a 17 month old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration. The healthcare professional asked how to proceed with this patient. The reporter consented to follow up.
This female subject was enrolled in an open label study title FLUARIX, FLULAVAL, FLUARIX Quadrivalent, FLULAVAL Quadrivalent Pregnancy Registry: a prospective, exploratory. cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX Quadrivalent or FLUVLAL or FLULAVAL Quadrivalent during pregnancy or within 28 days preceding conception. The subject received FLUVIRIN on an unknown date.  On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX.   Additional information received: Consumer's initials and date of birth were unknown. The Consumer was about to receive the vaccine. The reporter was first calling to see if the vaccine contains mercury and stated the Consumer has walked away. She stated she would inform Consumer to contact GSK if she finds out she is pregnant. Consumer may be pregnant. She is trying to become pregnant and doesn't know if she is pregnant. The healthcare provider didn't have any additional information.
Patient complained of "I cannot breathe." She could not speak and she was pointing to her throat.
Patient had sore arm on the day of vaccination. Per patient's nephew , the next morning patient experienced body pains, aches, headache . Onn Tuesday patient had fever.  Patient's condition  progressively got worse. He had difficulty breathing by Wednesday night. He had low oxygen levels at 80 per pulse ox reading. Patient was coughing up blood. Family took him to hospital on Thursday morning due to breathing difficulty and patient died 2.18.21 at 10 am
Pt. got shot on 5/25 but started feeling real bad arm pain on day 2. The pain got worse in arm and patient reached out to pharmacy questioning arm pain to which he was told it was an expected side effect of the shot but because he was still in pain he made an appointment with his doctor on the coming Monday, but unfortunately, he passed away on Sunday 5/30/21 and was found by neighbors. Brother wants to report death because he took the vaccine
Fever; Chills; Lack of appetite; Tired; Pain in the arm; It looks normal just little tender around the injection site; Injection arm swollen, red, and sore; Injection arm swollen, red, and sore; Temperature going up and down; This is a spontaneous report from a contactable consumer (patient).A 67-years-old female patient received BNT162B2, first dose via intramuscular, route of administration in Arm Left on 16Apr2021 11:00 (Batch/Lot Number: EW0169) as first dose, 0.3 ML single for covid-19 immunization. The patient Medical history included ongoing chemotherapy and did have COVID-19 Virus in Dec2020.Concomitant medications included everolimus 7.5mg and  Aromasin 25mg(both will take for the rest of her life).The patient takes a lot of vitamins to keep her immunity up. On 17Apr2021 the patient experienced fever, chills, lack of appetite, tired , pain in the arm it looks normal just little tender around the injection site, injection arm swollen red and sore , temperature going up and down. Caller waited three to four days. Then looked in a mirror and saw her arm was all red and swollen. Waited another day to see what would happen and it got worse. Went to urgent care. Doctor had seen some bad reactions, but stated caller's was the worst. Maybe a week ago, her arm was back to normal. Second dose COVID-19 vaccine was scheduled for tomorrow and she wants to know if this was too soon. Stated she was also on a chemo pill. Doesn't know if that has anything to do with it. She was taking a lot. Week after the COVID-19 Vaccine, she went to urgent care because her arm was still sore and swollen. Doctor prescribed Benadryl, antibiotic, and a cream. Cream was to put on the swelling part of her arm. Unable to provide product name of cream. Just finished the antibiotic four days ago. If she presses on the spot, it was still a little tender, but it wasn't like before where she couldn't even touch it. She would say five to six days prior to today, her arm was back to normal. About 4 days ago patient finished her antibiotics. Her arm just went down. The First noticed she was sick when she had chills and couldn't get warm. Was very cold. Turned up the heat and was under blankets. Temperature was 102 and was thinking about going to the emergency room. Got out of covers and took a cool bath and her temperature went down. Next day, 18Apr2021, temperature was back up to 102. Was taking an aspirin and drinking water trying to get her temperature right. Had five to six days of temperature going up and down. By the time she went to urgent care, which was seven days after the vaccine, she wasn't having fever or chills. stated chills coincided with the fever. Recovered completely from fever and chills and Loss of appetite as long as she had fever and chills, she wasn't hungry. Had it for about 5-7 days. Recovered somewhat. She still has an appetite, but was not eating s much. Stated she was overweight. On 24APR2021, outcome of events pyrexia, Chills, Lack of appetite, Tired and Temperature going up and down was recovered and outcome of other events was unknown.  Follow-up attempts are needed. Further information is expected.
Shaking, he was very stiff, eyes rolled back, ringing in ears, urination. Laid him back, removed needles from bed, yelled for APRN, blood pressure, APRN evaluate him. Sent him to ER. Went to give pt. his MENACTRA and Hep A. Pt. was nervous at first and had his mom on his (L) side. I first injected HPV and the HepA in the R IM deltoid. As soon as I removed Hep A pt. started to seize on me. Mom had son in her arm and we laid him down. After we laid him down, I grabbed the needles so he would not get stuck again from seizing. Ran out the door and hollered for APRN. When APRN entered the room patient was still seizing but only for a few seconds when he stopped. When he came conscious patient knew where he was but had ringing in his ears and could not hear. He also urinated on himself. Pt. was sent to ER per APRN.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020). On 28th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on the left deltoid. The pharmacist has denied permission to contact their pharmacy.
soreness at site of injection; lethargy; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not unknown) via an unspecified route of administration on 17Mar2021 at 09:45 (at an age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included spherocytosis and spleen removed at age of 2. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received one dose of ADVIL on Mar2021 (previous week) within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 11:00, the patient experienced tiredness, lethargy and soreness at site of injection. The patient did not receive treatment for the reported events. The clinical outcome for the tiredness, lethargy and soreness at site of injection was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.