chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist who reported for her daughter, and then from a contactable physician. A 18-year-old female patient received first dose of TRUMENBA (lot # J29203x6116), intramuscular in left deltoid, on 11Jun2015 at 03:30 pm, at 0.5 ml single. Relevant medical history included appendectomy in 2009, urticarial on 30May2013 and allergy to AMOXIL. Concomitant medication included ALEVE as needed when she had her cycle. On 11Jun2015 injection site was hurting and it swelled up very bad, it was very painful, the patient had chills and temperature rising (it had not hit 100, she did not measure at that time, she had broken out in rash and had also elevation of white blood count. Nausea and really bad headache developed on 12Jun2015 at 02:00 am. The patient was taken to the Emergency Room at the hospital because headache was so bad and the temperature did not go down. The patient had unspecified laboratory work in the emergency room on 12Jun2015 that revealed she did not had any infection. Full blood count on 12Jun2015 revealed elevation of white blood count. The patient was then discharged. On an unknown date the patient also experienced urticarial. The patient too ADVIL on 12Jun2015 at 07:00 am but it did not help for headache and put little bit of liquid in. The patient was given also BENADRYL, and TYLENOL. Rash went away and swelling went down and she was pretty sure that she was reacting to vaccine. The doctor put her on prednisone when she was returning to normal. Pharmacist mentioned that eh patient was recovering. The pharmacist mentioned that all the side effects (tenderness, swelling, nausea, headache, chills and temperature rising) that the patient had were all because of vaccine. The patient was brought to the pediatrician on `3Jun2015 and he also agreed that the meningitis vaccine did it. The physician considered that meningococcal group b rlp2-086 had a causal effect to the adverse events and that there were no adverse reactions related to ibuprofen. Follow-up (29Jun2015): New information from a contactable physician included: reporter's assessment. Follow up (06Jul2015): new information received from a contactable physician includes: TRUMENBA lot# updated, treatment updated, medical history updated, causal relationship updated. Follow-up attempts. No further information expected.
Tremors the morning after vaccine..ended up falling, also tremors every morning next two mornings. "Uncontrolled Tremors"
Patient alerted me he had trouble with passing out or dizziness in the past.  I gave the vaccine and patient immediately laid on the floor with legs up.  He felt better, then dizzy again.  Then better.  When he went to stand up a third time he got dizzy and passed out in the chair.  Another helped me lay him on the ground and he immediately came to.  We stayed another 25 minutes in room and another 20 minutes out front.  Gave a bottle of water but no medications.  Patient felt good after that and left.
pain and swelling at the injection site/ swelling in the arm; pain and swelling at the injection site/ pain in the arm; fever; CHILLS; DIZZY; FATIGUE; HOT; increased heart rate; NAUSEA; Sweating; burning up; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation. On an unknown date, the outcome of the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain, fever, chills, dizziness, fatigue, feeling hot, heart rate increased, nausea, sweating and burning sensation to be related to Shingrix.  Additional information was provided as follows: The reporter was the wife of the patient. The patient had vaccine in an unknown arm. The first symptoms that presented on the day of the vaccine in the early evening was pain and swelling at the injection site. The patient woke up in the middle of the night with all the other symptoms.  The patient had hot symptom and was described as he was burning up and sweating. The reporter consented to follow up.
I apparently was alergic to the vaccine; The 2nd made me very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization.  The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "I apparently was alergic to the vaccine"; ILLNESS (non-serious), outcome "unknown", described as "The 2nd made me very ill".  Additional information: The patient wanted to let know that patient took the 2 doses of the vaccine. The 2nd made patient very ill. Patient apparently was allergic to the vaccine because patient had been very ill as a result. Patient had not taken any more since then, none of the boosters. Patient had been afraid to. Patient know it was difficult to confirm that problems were caused by the vaccine, but know it to be true. Just one of the unfortunate ones that it disagreed with. Thought should know. Patient know that patient was not the only one.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After receiving PNEUMOVAX and ZOSTAVAX pt developed throat constriction 20 minutes later - resolved in 1 hour after antihistamine. Next am awakened with facial swelling (L) arm (upper) swelling (site of ZOSTAVAX) and hives lower arm. Pt reported on 7/25 these reactions which were almost resolved by antihistamine use. Never came in day of shots or called 911.
Mother report approx 4hr after 1st pfizer covid vaccination patient started with red spots around bilat eyes, she took patient to ER and was diagnosed with adverse reaction to covid 19 vaccination. ER chart notes not present during the visit,  Discharge paperwork indicated patient was dc'd home on cetirizine
25 minute seizure - generalized. Temp 37.7 prior to seizure. Seizure was gen. tonic-clonic. Required ATIVAN x 2.
08/11/23 Patient was given a kinrix (which has Dtap and polio)and a IPV opposite legs.  patients parents were informed immediately and provider was informed and spoke with the mother about possible side effects and if needed ice to injection sites and tylenol for pain.   08/16/23 I spoke with mother and she states child had no adverse effects.  Was acting normal and small lumps under Kinrix site on left and proquad site on right.  Which is normal she states.
postherpetic neuralgia; vision issues; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently 65-year old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 21-SEP-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues. The outcome of herpes zoster, postherpetic neuralgia and visual impairment was not reported. The reporter considered herpes zoster, postherpetic neuralgia and visual impairment to be related to zoster vaccine live (ZOSTAVAX).
pt recvd vax 24AUG93 & noted to be taking steroids; 23SEP93 pt seen by MD because of cough, sore throat, & pruritic rash; PE heard rhonchi; pt had blisters; pt later determined to have toxic epidermal necrolysis; also oliguria; pt comatose
she felt like it went all over to all different places inside her arm; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (she felt like it went all over to all different places inside her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ANXIETY (she felt like it went all over to all different places inside her arm). At the time of the report, ANXIETY (she felt like it went all over to all different places inside her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2021-028888 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-028888:Husband case
pt started experiencing a small red mark (dime size) about 3 inches below injection site 2 to 3 days after administration. She just notified us today 1/29/2021 small spot has now increased to rash 3 inches from injection site about 1 inch wide and 3 inches long. No other issues reported
This case was reported by a physician via sale representative and described the occurrence of alopecia in an infant male subject who was vaccinated with ENGERIX. Previous and/or concurrent vaccination included ENGERIX B; unknown; unknown given on unspecified date. On an unspecified date the subject received 2nd dose of ENGERIX B (unknown). At an unspecified time after the vaccination with ENGERIX B, the subject developed alopecia. The subject did not complete the series and never received a 3rd dose of ENGERIX B. The reporting physician, who was not the subject's caregiver at the time of the event, was inquiring about ENGERIX B causing alopecia. It was unknown which manufactured Hepatitis B vaccine the infant subject actually received. The subject is now in middle school. At the time of reporting the event was resolved.
ON 1/21/21, DEVELOPED FATIGUE, BODY ACHES, AND INCREASED WEAKNESS
Swelling at site, raised and red day after vaccine. Next day, entire left upper arm to elbow swollen and red, warm.
COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "COVID 19 Treatment". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient also received treatment with Paxlovid from 07Oct2023 to 11Oct2023 for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336347 Same patient, different product, different dose/event;
Pt to ED 8/28 for abdominal pain, constipation x 2 weeks, and nausea. COVID+ 8/28, respirations even and unlabored, denies chest pain or shortness of breath. 8/29 pt denies dizziness, SOB, and chest pain, has fever of 101.3. 8/30 pt to start patient on oral Augmentin, requesting prn med for cough. Pt discharged 8/31.
This is a spontaneous report from a contactable Nurse via Pfizer Sales Representative. An 87-year-old male patient received PREVNAR 13 at single dose, FLUZONE at unknown dose, both via an unspecified route of administration on 16Oct2018 at different arms for immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, ongoing current smoker. The patient's concomitant medications were not reported. The patient came for physical, healthy. The patient administered high dose FLUZONE and pneumococcal 13-val conj vac (dipht crm197 protein) on different arms 16Oct2018. On 22Oct2018, the patient was taken to ER (emergency room), could not get out of bed, had a cough and discharged same day with antibiotics, diagnosed as bronchitis at ER. Returned to clinic for follow up on 25Oct2018, the patient was still generalized weakness (Oct2018), still had cough (Oct2018), fever of 101 degrees with chills the night before on 24Oct2018; also low blood pressure at time of visit on 25Oct2018. Dr. diagnosed as septic after review lab culture from ER, which indicated gram positive cocci on 25Oct2018.The outcome of 'Bronchitis/Cough' and 'Generalized weakness' was not recovered, the outcome of other events was unknown. Sender's Comments: Bronchitis/Cough and Sepsis with lab culture indicative of gram positive cocci are associated with the incurrent bacterial infection secondary to the underlying chronic obstructive pulmonary disease unrelated to PREVENAR 13. Hypotension, fever with chill and asthenia are compatible with the symptoms of sepsis. 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.
Pt had previously had COVID in late Oct/early Nov 2020. Pt received both Covid 19 Pfizer vaccines, on 3/1/2021 and 3/22/2021. Pt went into labor at 36 weeks and was tested as part of routine admission on 3/31/2021, this SARS-CoV-2 test resulted positive. Pt was reported to be asymptomatic. Pt completed a normal, healthy, vaginal delivery.
Moderna COVID?19 Vaccine  Fever (highest 101.1), sweating, body aches, headache, nausea
"regular side effects"; difficulty breathing; "long haulers syndrome"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT ("regular side effects"), DYSPNOEA (difficulty breathing) and POST VIRAL FATIGUE SYNDROME ("long haulers syndrome") in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MDA) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced ADVERSE EVENT ("regular side effects"), DYSPNOEA (difficulty breathing) and POST VIRAL FATIGUE SYNDROME ("long haulers syndrome"). The patient was treated with PREDNISONE ongoing since an unknown date for Dyspnea, at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT ("regular side effects"), DYSPNOEA (difficulty breathing) and POST VIRAL FATIGUE SYNDROME ("long haulers syndrome") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: negative (Negative) negative. In January 2021, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, X-ray: showed long haulers (abnormal) showed "long haulers syndrome".     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included prednisone and inhalers.
Information has been received from a consumer concerning her 18 month old daughter with no pertinent medical history or drug allergies who on 04-OCT-2005 was vaccinated with a dose of VARIVAX (Oka/Merck). There was no concomitant medications. On that same day 12 hours after vaccination, the patient experienced fever, vomiting and rapid heartbeat. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The symptoms lasted for about 1 week and the patient subsequently recovered. No further information was reported. There was no product quality complaint. No further information is available.
While I was having my blood pressure taken we noticed skipped heart beats.  We decided to visit Dr. our cardiologist who provided a heart monitor which I wore for 2 weeks.  Ventricular tachycardia and supraventricular tachycardia were both diagnosed from the heart monitor data.  As time progressed the incidence of skipping heart beats disappeared.  I received a booster in February of 2022.  The skipping heart beat problem reappeared.  I am hesitant to get any more vaccine injections for covid 19 because of my reaction.  It is now October 2022 and I have no symptoms.
Brain Fog. Shortness of breath, pulse ox levels 90-92%. BP way up. Blood sugar levels 300-400 ranges. Fatigue. Night sweats. No taste or smell.
12-year-old female given pediatric dose of Pfizer despite being old enough to receive the adolescent/adult dose. Pediatric dose administered again for two doses of pediatric Pfizer. No adverse effect.
VERY LG RED AREA OVER RIGHT THIGH. IRRITABLE, BUT CONSOLABLE. CRYING
Approximately 3-4 minutes after vaccination the patient was seated and fainted and fell over. Her husband caught her so she did not hit the ground. She remained unconscious for approximately 3-4 minutes and appeared to be shaking/trembling. 1 dose of epinephrine (0.3mg/ml) was given into lateral left thigh and patient immediately regained consiousness. She exhibited confusion and has no memory of the event. She reported chest pain and severe nausea, without vomiting and extreme thirst. EMS arrived and checked the patient out with no remarkable findings.  The patient was still experiencing chest pain and advised to go to the hospital for examination
He said he wanted to report a drop in his blood pressure the next day and his normal blood pressure is 120 or 125 over 70 and his blood pressure went down to 70/50.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First booster dose, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: BLOOD PRESSURE DIASTOLIC DECREASED (non-serious), outcome "unknown", described as "He said he wanted to report a drop in his blood pressure the next day and his normal blood pressure is 120 or 125 over 70 and his blood pressure went down to 70/50.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Calling about the Covid-19 second booster shot. The reporter said he wanted to report a drop in his blood pressure the next day and his normal blood pressure is 120 or 125 over 70 and his blood pressure went down to 70/50. reporter said no when asked to complete report and said he just wanted to let Pfizer know. reporter declined to complete a report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-2022) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 31-Jan-2022, Date(s) of administration of vaccine 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 31-Jan-2022 the vial was initially stored in the refrigerator. The vials did not undergo any temperature excursions.   This case was linked to MOD-2022-525860, MOD-2022-525834, MOD-2022-525851, MOD-2022-525860, MOD-2022-525866, MOD-2022-525870, MOD-2022-525874, MOD-2022-525880, MOD-2022-525890, MOD-2022-525893, MOD-2022-525896, MOD-2022-525903, MOD-2022-525906, MOD-2022-525912, MOD-2022-525915, MOD-2022-525918 (Patient Link).
about 5 minutes after receiving, patient experienced tingling in fingers, which changed from one finger to another then also down outer aspect of palm of right hand. Shortly after, legs started feeling cold sensation in them and then started feeling "achey " in legs; called physician, who recommended patient wait longer than typical wait period, which patient did...waited one hour after shot. assisted her to standing and walked to vehicle. followed up with a phone call to her twice through out day and patient was ok.