chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to a 14-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 28-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit (F) and the higher was 54 (F) for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
itch 9APR;rash, itch, swollen, warm told to call clinic & instructed to take DPH;15APR97 problem resolving w/DPH;
This spontaneous report was received from a registered nurse refers to a 18 year old patient(unspecified gender). The patient had no prior vaccination history. On an unknown date, the patient was vaccinated with a first dose PROQUAD (merck), (lot number, expiration date and route was not provided). No concomitant medications reported. Additional information has been requested.
Pt is complaining of painful swelling in right arm after receiving PNEUMOVAX 23. He states that the pain has spread up his neck and it is hard for him to turn around in bed and he needs assistance to get in and out. He tried OTC products but nothing has helped. Pt is planning to go to ER.
PT VACCINATED WITH RUBELLA VACCINE C/O COLD LIKE SYMPTOMS & ONE CONVULSION; RESULTS UNKNOWN; PT GIVEN COMPENSATION PROGRAM ADDRESS.
Vaccine administered at 10AM. At 1015 observer noticed she was feeling anxious patient walked to high observation area for further evaluation. Patient stated she was feeling anxious and that the light was bothering her, she used her inhaler prior to moving to high observation also stated the light triggered her epilepsy. Patient transfered to dark private area by high observation nurse to decrease stimuli. Patient stated she felt like a seizure was going to happen layed on her left lateral side vs 135/83 p 118 rr20 temp 36.7 sat 88%. Patient going in and out of sudden repeated episodes. 1035 ems activated.
Burning in chest, Throat closing / tightening up, difficulty and popping while trying to swallow, Dry mouth and throat, slight swelling of tongue, slight dizziness, elevated heart rate, redness of skin on hands, neck and face, shakiness / trembling.  And for some reason I felt angry as if something quickly changed my attitude. I was previously very happy with how easy the shot went and thought I'd be out within  :15 minutes.  I was told by a nurse they could administer an epipen of benedryl If needed.
Patient reports onset of rash and itching accompanied by fever (he did not take his temperature) on the evening of Monday, 10/31/2011. patient took Tylenol and Benadryl at home, and saw a physician the next day, who prescribed Prednisone for the symptoms and told patient the reaction was likely from the flu vaccine, since no other cause could be determined.
Pt had a anaphylactic reaction after his vaccine shot today and (PA-C) evaluated him. EMS called  at 9:50 am, they arrived her at 10:04. Vitals: B/P -120/787 (left arm)- R/R- 16; H/R- 115/ 02- 97.
Sudden death 17 hours after vaccine shot.  Ambulance to Hospital.  Unable to resuscitate.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Jun2021 (Lot number: EP6955) at the age of 13 years as dose 2, single and intramuscular, administered in arm left, administration date 27May2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. Relevant past drug history included name of drug was reported as no and reaction was allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has been tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Abbott BinaxNOW : Positive / PCR: Positive"; COVID-19 (medically significant) with onset 25Dec2021 18:00, outcome "unknown", described as "Abbott BinaxNOW : Positive / PCR: Positive/ sore throat/Stuffy nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab; (28Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
I was vaccinated nine days ago.  I have consistently been having chills, a dull headache and fatigue.  I was really sick by the end of the day after the vaccine.  The fatigue, initially, put me in bed for a few days.  It is not as severe now.  It is mild to moderate.  I feel week sometimes.  It comes and goes.
pt recvd vax in SEP95 & pt found it hard to concentrate;subsequently pt called the MD ofc & was told that had ben given 10x recommended amount of the vax;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years 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: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no Known allergies. Patient received COVID 19 Treatment (Paxlovid) from 06Jul2023 to 11Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300251297 Same patient, different drug, different event;
Less diluent was added to the vaccine. A .3 of the sterile diluent was added to the vaccine instead of 1.3ml of diluent
Pt received moderna vaccine on 03/05/21 and 04/02/21. During pt's rehab hospitalization, pt developed a temperature. Pt was tested for COVID on 12/10/21, which came back positive.
Paralysis - Guillain-Barre Syndrome. Hospitalized 10/20/09. IMG, plasmapheresis TRT, PT.
Patient presented for D2 of Pfizer and disclosed after D1 she went to hospital for c\o "throat closure" and received Epi and Benadryl. Uncertain which hospital and how long stay was.
Pfizer-BioNTech COVID19 Vaccine EUA.   Evening of 3/31/21 was normal.  Morning of 4/01/21  felt body aches and tired. By 6 pm, chills set in.  Shivered for 4 hours (est.) even with two blankets on me and a space heater near by.  Had hot  tea and oatmeal to warm body core. May have had temperature but didn't take it.  Slept under extra comforter and was too hot in middle of night. Peeled off covers until later when I was too cold.  Pulled covers back up.  Sluggish at first in morning.  Feeling fair now.
Patient did not developed any adverse event, instead patient was given the wrong  vaccine. Patient received Regular Covid-19 vaccine instead of Bivalent Covid1-19 vaccine.
Swelling started 4/6/07 with swelling of the earlobe on one rt side of face.Swelling moved from front of ear to ear lobe straight across cheek bone dropped in jowls/ neck. Rash in temple area.
Intussusception 3/1 - 3/2/ 2014. Enema reduction. ? Rash on the face 24 hours after vaccine. Resolved in 2 days.
Following vax pt exp fever of 106 taken in hosp, rash, pain in joints, screaming which lasted for several hrs, hypotonic, hyporesponsive episode;
Large, red area near injection site. No pain. Was hard, but improved some. Advised patient to contact her physician.
she sees her neurologist every 3 months for migraines; shot in Jan2021 and in early Feb2021 and got boostered in Jul2021; scoliosis; fibromyalgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date Jul2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "INFLUENZA VACCINE" (unspecified if ongoing), notes: gets the flu shot every year and other boosters. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 2), administration date: Feb2021, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "she sees her neurologist every 3 months for migraines"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "shot in Jan2021 and in early Feb2021 and got boostered in Jul2021"; SCOLIOSIS (non-serious) with onset 2021, outcome "unknown", described as "scoliosis"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "fibromyalgia".  Additional Information: Caller states she had her shot in Jan2021 and in early Feb2021 and got boostered in Jul2021. Caller would like to know if there is any information regarding emergency authorization for a second booster? Caller states it has been 6 months and she believes in these shots. Caller states she gets the flu shot every year and other boosters. Caller states she side effects to any of the vaccines. Caller states she sees her neurologist every 3 months for migraines and has a primary care doctor and orthopedics. Caller states she is in a location where she believes we were doing some research in which is 20 miles from her house. Caller states she is willing to go into a testing protocol. Caller states she would be more than happy to be a test subject but states she does not want the placebo and she wants the real thing. Caller states she is willing to be a participant in the clinical trial? Description of Potential AE I live in (State and city name) and I got my Pfizer Covid vaccine very early last year and got my booster in July. I want to know if there will be a second booster. I want to get in a trial if there is one. I have migraines, scoliosis and fibromyalgia. I have done a trial before for migraines and I think that big pharma helps but I think the government is trying to scare everyone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
THREW UP THE THIRD DOSE; This spontaneous case report was received from a pharmacist (PVX2019-553) on 28-Feb-2019. The report describes a 54-year-old female consumer who "threw up the third dose". The consumer was receiving Vivotif capsule for an unknown indication.  It was reported that the consumer took the third dose of Vivotif on 28-Feb-2019, and threw it up after 1 hour. She saw the capsule in her vomit.  The action taken with Vivotif with respect to the event "threw up the third dose" was unknown.  The clinical outcome of the event "threw up the third dose" was unknown.  Company's Comment: In this case, a 54-year-old female consumer "threw up the third dose" following administration of third dose of Vivotif .There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif was assessed as possible. The event is known to occur with Vivotif and is labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, a 54-year-old female consumer "threw up the third dose" following administration of third dose of Vivotif .There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif was assessed as possible. The event is known to occur with Vivotif and is labelled as per CCDS.
Patients wife reports injection site erythema 1" by 1" blotchy redness, swollen, warm to touch. Soreness & chills.
This spontaneous report as received from a pharmacist refers to a 2 year old patient. On 31-JUL-2013 the patient was vaccinated with PROQUAD (Merck), full dose, subcutaneously (lot# and exp date unspecified), and VARIVAX (Merck) full dose subcutaneously (lot# and exp date unspecified). No adverse effects was reported. This is one of two reports from the same reporter. MARRS: 1308USA002722. Patients outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the first of three reports.  A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced Bell's palsy. The outcome of Bell's palsy was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.          Follow-up (06May2021): This is a follow-up report to notify that the case 2021345756 and case 2021507291 are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 2021507291.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345757 same reporter, product, and event; different patient.;US-PFIZER INC-2021345758 same reporter, product, and event; different patient.
He had a fever and possibly a sore throat. The only treatment was TYLENOL and MOTRIN to manage the fever. He had a fever all of 08/08/2022 and most of 08/09/2022. He has not had a fever today. He tested negative for COVID-19, Flu and Strep. Doctors just thought maybe he caught something viral from somewhere. He has been going to daycare recently (first time ever) so we feel like it may be mostly related to that.
Fever, arm pain, heart palpitations, arrhythmia, chest pain, nausea and severe stomach pain, inability to eat due to nausea/stomach pain. Ibuprofen and liquid diet. Still ongoing after almost 3 weeks since 2nd dose
Initial unsolicited report received from consumer on 02 November 2016. This case involves 10-month-old male patient who was vaccinated with a dose of FLUZONE QUADRIVALENT and dose of ACT HIB (batch number, expiry date, route and site of administration was not reported for both vaccine) on 13 October 2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported as unknown. Patient received one other vaccine as a concomitant six weeks prior but patient declined to say what it was. On 20 October 2016, seven day following the vaccination, patient woke up with numbness of right face which persists and was diagnosed with Bell's palsy. On an unspecified date patient was hospitalized. Lab data and corrective treatment was not reported. Patient was not recovered from events. List of documents held by sender: none. Sender's Comments: Bells Palsy is listed with INFLUENZA QUADRIVAL A-B VACCINE but unlisted with HIB (PRP/T) VACCINE. This is poorly documented case. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Face, shoulders, top of arms, and neck turned red; Lips tingled; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face, shoulders, top of arms, and neck turned red) and PARAESTHESIA ORAL (Lips tingled) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Face, shoulders, top of arms, and neck turned red) and PARAESTHESIA ORAL (Lips tingled). At the time of the report, ERYTHEMA (Face, shoulders, top of arms, and neck turned red) and PARAESTHESIA ORAL (Lips tingled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
7/19/02-Pt went out to car and returned complaining of feeling hot and difficulty swallowing. Pulse ox 95-98%; Lungs clear with good air movement; BP-124/74; Started to develope hives and was given Benadryl 25mg orally; After 15 min. no improvement; BP-128/72; Pulse ox 95-98%. Complained of all over itching. 0.2cc of 1:1000 Epi given. Hives at site of MMR injection. After epi, had immediate resolution of hives. 30 minutes later, itching throat and hives returning. Repeat epi 0.2cc, 1:1000 Epi. After 55 minutes, developed hives again. Admitted. Discussed with Peds I.D. fellow recommends giving steroid burst.
10min after vaccine was given patient c/o dizziness he has known HTN took is morning medication 1 hour ago. Did not eat breakfast. BP 198/90, HR 68,98%,18 patient given water and crackers put in supine position. Rechecked BP 170/88 then 160/78 felt well after 30 min and was discharged
injection site sensation of warmth; sensitivity to touch; injection site pain/whole left arm pain / arm soreness and tenderness; tenderness; extreme body pain; extreme fatigue; flu-like symptoms; feeling cold; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than an hour after receiving Shingrix, the patient experienced injection site warmth, touch sensitivity increased, pain in arm, tenderness, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent. The patient was treated with ibuprofen (Advil) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site warmth, touch sensitivity increased, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent were recovered/resolved and the outcome of the pain in arm and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site warmth, touch sensitivity increased, pain in arm, tenderness, general body pain, fatigue, influenza-like symptoms, feeling cold and appetite absent to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient experienced injection site pain with injection site sensation of warmth with sensitivity to touch.  Then within 6 hours, the patient started to experienced whole left with extreme body pain, with extreme fatigue with flu-like symptoms which includes feeling cold.  The patient also reported lack of appetite. The reporter was consented to follow up. This case was linked with case US2020028081, reported by the same reporter.
Pt said about 2 weeks after received vaccination he lost vision in one eye. He saw a doctor and they diagnosed him with MEWDS. According to doctor per pt, the vision may come back in a few weeks (it has not yet) or it may spread to the other eye and he may become completely blind. Dr believes the immunization could be the cause (but couldn't say for sure) because of patient's prior history of retinal detachment.
"Moderna Covid-19 Vaccine EUA"  - Swelling and redness with slight bumps on outside of left arm at the injection site.  No fever, no other issues.  Did not show up as an issue until 8 days after dose 1 injection.
2 inches below lowest site: warm, red, slightly swollen arm. She rested for 3 days and the swelling went down, warmth went away.
The pt experienced an elevated temp of 104, rash to entire body which started 7 days post vax. Went to the MD and Motrin was ordered. The parent was instructed to give child fluids and cool compresses to rash if continues.
I received my Moderna booster for COVID-19 on 12/4/2021. On 6/7/2022, I began to feel really run-down during the evening. I also developed a sore throat, hoarseness, and a headache. The symptoms continued into the morning of 6/8/2022. On 6/8/2022, I also had chills and fever; I don't know what my temperature was, since I was unable to find my thermometer. During that night, I developed body aches while I was in bed. By midday on 6/9/2022, the chills, body aches, and fever all dissipated. From that point, I just had sniffles, runny nose, fatigue, and no energy; I basically just felt like I had a cold. On 6/10/2022, I had a minor cough that lasted only briefly. On 6/10/2022, I took a home antigen test, which yielded a positive result. During the next couple of weeks, I had lingering cold-like symptoms like fatigue, lack of energy, runny nose, and headache. I felt better some days and felt worse on other days. The symptoms just waxed and waned. I finally felt like I had made a complete recovery by 6/22/2022.
UNFORTUNATELY, THE PATIENT RECEIVED UNDILUTED PEDIATRIC COVID 19 VACCINE, 0.2ML DOSE
Two minutes following administration of the Pfizer Covid-19 Booster, patient felt flushed in left cheek only. Vital signs were taken and were within normal limits of 144/92 BP, Pulse ox 96%, HR=88. Patient had no difficulty breathing, no swelling of face, lips, or throat. Patient had no generalized signs and symptoms. Patient did verbalize that left ear/cheek area felt "tingling" and she had a headache. Her primary care physician was in office at the time, and he assessed her. Patient was given a total of 50mg of liquid Benadryl in the span of 30 minutes. Patient was observed x 75 minutes from time of administration until Pt left to go home. When patient was dismissed she stated she felt "100% herself" A follow up phone call by this writer two hours later after patient went home indicated that patient was continuing to have no s/s of allergic reaction and stated she felt "100% completely fine"
LOCALIZED REDNESS & SWELLING AT RIGHT AND LEFT DELTOID. WARM COMPRESS AND BENADRYL.
3-4 weeks after receiving first dose of Lymerix, pt developed pain and swelling of the right knee.  The right knee pain continued. Subsequent to receiving second dose of Lymerix, the pt developed pain and swelling of the left knee and the right knee pain increased. At the time of evaluation the swelling of his joints was down. The right knee was initially warm but resolved prior to evaluation. Pts wife stated that she thought that the pt was diagnosed with arthritis. Pt was treated with diclofenac sodium/misoprostol. The most recent information, reports the outcome of the event is ongoing.
pain in arms, feet & legs;pins & needles feeling in toes & finger tips, sl numbness in both;