chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning his 5 day old female daughter who on 23-OCT-2008 was vaccinated PO with the first dose of ROTATEQ vaccine. No adverse effect was reported. It was unknown if the patient sought medical attention. A product quality complaint was not involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2008. Follow-up information was received from a physician who reported that the patient (6 pounds, 6 ounces; 20.5 inches) with no known illness at the time of vaccination, and no known pre-existing allergies, on an unknown exact ime was vaccinated with ROTATEQ vaccine (Lot No 1033X) at private doctor's office/hospital by a nurse after not following protocoll to properly identify patient having the parents sign consent and then administering.   Follow up information received on 23-DEC-2008 from a physician who reported that the patient's birth weight was 6 pounds 13 ounces and that the lot  number of the ROTATEQ vaccine administered is 651430/1033X. No further information is available.
the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist.  A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 10Jan2021 at single dose for COVID-19 immunization; and diphenhydramine hcl, via an unspecified route of administration from an unspecified date at unknown dose for premedication. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2, lot number: EL0140, via intramuscular in left arm on 20Dec2020 at single dose for COVID-19 immunization and experienced itching. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient was pre-medicated with diphenhydramine prior to the second dose of the COVID-19 vaccine. 9 minutes after the vaccination on 10Jan2021, the patient felt itchy and flushed then received oral dexamethasone as treatment for the events. The patient was sent out with oral dexamethasone home. The outcome of the events was recovering. The action taken in response to diphenhydramine hcl for the events was unknown.
fever, body aches, headache, injection site pain and soreness, injection site redness and swelling, nausea
Approximately 3 days after Shingrix immunization, patient developed tingling, numbness in feet that progressed to Guillain Barre Syndrome (acute inflammatory demyelinating polyneuropathy) confirmed by clinical exam, lumbar puncture and nerve conduction testing. She had weakness > numbness mostly in legs and unable to ambulate. Only mild tingling in hands. Treated with IV immune globulin infusions after admission to hospital 9/2/20
Dad came back to health department without child. Stated he had a rash around his ears and head is turning red, Instructed dad to have mom take child to doctor and let us know what doctor says. Took to doctor.
p/vax pt had body aches & fatigue; pt went to ER Dx viral syndrome; tx: APAP & Quarters; NCNS
Pt exp h/a & blood pressure of 120/100 following vax w/Hep b; On the evening of the vax pt exp a sore arm;
Report received on 17-NOV-2009 from a daughter of a patient regarding a claim in litigation. The female patient (date of birth unknown) received the "flu shot" (manufacturer and lot # not provided) on an unspecified date in 2009. On 07-SEP-2009, the patient died possibly due to the flu shot. No further information was provided.
Sore arm day of shot.  4/10 6:30am woke with low fever felt sluggish  and nauseous throughout day. 4/11 felt normal
Within 24 hrs of receiving H1N1 nasal mist - Hives - 48 hours post mist- face/trunk/scant arms - legs erythema much of time - No oral/lung involvement. Also on antibiotics - CEFZIL - 4th time exposed and never had Rxn.
On 6-27-12 she said she got a vaccine - shingle, 2 days later knees became swollen & then got better.
After - about 3 hours later: sore arm - lasted two days. On 28th, I started getting a runny nose; coughing and sneezing and sore throat. That kept going for a few days. On 30th, I found out I was exposed to someone that had COVID. 30th was tested and results on 31st - positive. I went to URGENT Care to get the test. Albuterol inhaler was prescribed; and an Antibiotic for my symptoms. She told me not to start the medication until I found out that I was positive or not. So I started the meds on the 31st. I got sicker before I got better - got chills and sweating (back and forth); felt really tired and out of energy and had  brain fog and I tripped on things in front of me. I didn't have any appetite. Had to force myself to eat so I could take my medicine - for about a week. I was coughing a lot. Took over the counter cough medicine especially night because it was disturbing my sleep. Later, I had a telehealth appt with my primary care dr appt - on January 8th. And she prescribed a steriod inhaler - Budesonide Formoterol Fumarate Dihydate- inhalation aerosol and I'm still taking that today because I still have a cough. Had the second dose of the vaccine on January 26, 2021 at 6:30PM. No reaction to that dose except sore arm.
Irritability: "Screaming" "inconsolable" X3 hrs (starting approx. 1-2hrs after vaccination) vomiting X1 approx 4 hrs after vaccination.
sudden loss of hearing; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication and medical history was not provided. On or around 09-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine (unspecified date), the patient suffered from sudden loss of hearing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the product. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was assessed as related by the lawyer.   The event of loss of hearing was considered as disabled by the lawyer.  Upon internal review, loss of hearing was determined to be medically significant.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant information was reported. BUD reported as 02Sep2021. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant Live follow-up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Soreness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-344335, MOD-2021-336820 (Patient Link).
Pateient received HPV vaccines on 8/14/13 and 10/25/13 through another provider.  She started having significant panic and anxiety symptoms requiring medication that began ion 11/27/2013.  Brother also had the same type of reaction from two of his HPV vaccines.  There is FH of anxiety, and patient has some anxiety baseline, so difficult to tell if vaccine related.
sore arm; chills; sweating; tired; achy; This is a spontaneous report received from a contactable consumer and a non-contactable consumer (patient). These consumers (patient and patient's friend) reported for a patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On an unspecified date, the patient reported that post second Pfizer vaccine experienced sore arm, at about 14 hours post vaccine (while sleeping) chills, no fever (at least not when I checked overnight), sweating (still no fever or else I just checked it when no fever) and woke up feeling ok. Maybe a little tired and achy but could be from how the patient slept overnight. It was better than covid. The outcome of the events was unknown.  Information about lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
pt recv vax & devel cough p/vax;2 days post vax pt dx bronchiolitis & rx ATB;5 days post vax pt hosp in  ICU;pt unresponsive x 5 days;CXR revealed pneumonia in one lung field w/some atelectasis & patch atelectasis in other; dx RSV infect
During first 12 hrs after injection, I noticed only redness, mild discomfort and itching at injection site.  By 12 hrs later, I began to experience fever, chills, nausea, headache, muscle and joint discomfort, dizziness, diarrhea, fatigue.  This lasted all night.   The day following injection I still had a fever (102) and chills and redness on arm had increased in size; also headache (predominately in both eyes).   I slept a lot during that day.  Day 3 low grade fever persisted. Used Tylenol with good results.  By day 4 feeling much better!!  Redness at injection site increased but less itching and discomfort. Regaining energy.
Syncopal attack; Vaccination related malaise; Light-headed; Confusion; Chest pain; Swelling abdomen; Abdominal pain; Shortness of breath; Sweating; Pain localised; Diarrhea; Nausea; Chills; Vomiting; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Syncopal attack) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and PANCREATIN (CREON) (Oral) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Syncopal attack) (seriousness criterion medically significant), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncopal attack), VACCINATION COMPLICATION (Vaccination related malaise), DIZZINESS (Light-headed), CONFUSIONAL STATE (Confusion), CHEST PAIN (Chest pain), ABDOMINAL DISTENSION (Swelling abdomen), ABDOMINAL PAIN (Abdominal pain), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), PAIN (Pain localised), DIARRHOEA (Diarrhea), NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Blood pressure measurement: 114/65 (abnormal) 114/65 Blood Pressure Abnormal. On an unknown date, Heart rate: 40 (Low) 40  Heart rate decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment Medication details was provided.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
No additional AE reported; administration of PROQUAD was outside the PI recommendation; This spontaneous report was received from the supervisor from pediatric clinic referring to a 15 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (unspecified rHA or HSA) (strength, dose, route, frequency, were not reported) for prophylaxis. The valid lot number T018278 was reported, with expiration date reported as 23-NOV-2021. The reporter believed this was his first and only dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). She wanted to know if he needed to receive his Measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MMR) and varicella vaccines separately at a later date, since his age at administration of PROQUAD was outside the PI recommendation as this information was discovered on 26-OCT-2020. No additional adverse event (AE) reported.
From telephone contact received at manufacturer on 06/24/2002 regarding 3 patients who received Tripedia vaccine (lot #U0532AA), IPOL (lot #T12942-2) and Prevnar on 04/05/2002. The mother of the 3 patients called to report that all 3 of her children had reactions to vaccines administered. She reported that one month later all 3 had seizure like activity, high fever and screaming and shaking. Twins and younger baby. She reported that she could not awake youngest all night. Twins also slept unusually long. One twin on 05/13/2002 was limping and taken to the ER, had an ear infection and on 05/16/2002 had spell in high chair which mom said he was unconscious for 1 hour. Other twin on 05/18/2002 had a seizure. She still awakes at night screaming and shaking. Youngest still has shakes and tremors. A neurologist has evaluated them all and attributes to immature immune systems.
raised red, hot, itchy rash.  Benadryl calamine lotion.
Swelling and pain from shoulder, deltoid & collar bone. Advised TYLENOL, ice packs & antihistamines. RTC if no improvement.
Patient reported feeling light headed, speech began slur, and she slumped her body in the chair, rolled her head...felt her pulse it was elevated and she appear to be sweating.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
The consumer had flu shot and had some problems where the shot was given. Patient complained of mobility problems in that arm.
Information has been received from a physician concerning a 35 year old female pt who was vaccinated with MMR and subsequently, the pt developed esophagitis. The pt sought unspecified medical attention. Additional information has been requested.
One week after my vaccination my left arm felt sore down to my hand and my hand felt a little numb.  The day after on March 5 in the afternoon my arm felt hot and there was a sort or lump just below the injection area and it was swollen and red about a 3 inch circle.   This lasted Friday, then the swelling began to go down and was hardly noticeable the next evening except for a some redness that lasted for a few more days.
Since one week after receiving my second Moderna shot, I have been having full body hives, head to toe. The hives are worse in the morning but if medication is not taken, they will form over my whole body.
Migraine - started around 12 hours after the shot, lasted for 48 hours, very intense; after effects of migraine lingered for 48 additional hours Heart palpitations - sporadic for 48 hours Arm soreness - some soreness in the arm, but relatively minimal; lasted about a week Hot/Cold - alternating temperature fluctuations of hot to cold almost like a fever but temperature was never above 98 (avg temp 97.6)
- Chilling, diarrhea, abdominal pain, wetting at night, tiredness, body ache
SHE FELT PAIN WHEN THE NEEDLE WAS STUCK IN THE BONE AND FELT NUMBNESS IN HER FINGERS FOR ABOUT 10 MINUTES. BP 169/83 PULSE 76 O2 96% REPEAT BP AFTER 10 MINUTES  144/73 HR 76 O297% PATIENT STAYEDN IN OBSERVATION FOR 30 MINUTES, STATES AFTER 30 MINUTES, NO NUMABNESS NOTED ANYMORE. PT VSS. PT DENIES SOV OR C/P GIVEN INSTRUCTIONS TO NOTIFY PCP IF NUMBNESS RETURNS
Patient experienced an upper chest and bilateral shoulder rash, facial edema, and a tingling sensation past receiving the vaccine. A discussion was held between Provider, PHARM-D  and OIC that resulted in the patient not being a candidate for a second dose.
Adverse Event: 1305: PT c/o feeling lightheaded, slightly nauseated. RNs on site responded, assessed, obtained vital signs (1309: BP 100/60, HR 69, SPO2 96% on RA). PT presented with diaphoresis and pallor. Aid was called at 1305, EMTs responded at 1315 after completing another call. RNs mentioned above provided care to PT until their arrival; PT remained stable with no LOC during encounter. EMTs obtained VS at 1315: (BP 118/P, HR 80, SPO298% RA). Treatment: Provided juice and water, assessed PT, obtained vital signs. Outcome: PT reported "I feel fine now. I can walk fine." PT appeared to be at baseline and was medically cleared by EMS.
Pt recvd 3 doses of Engerix B on 25FEb90, 26Mar90 & 27Apr90; 0,1, 2 dose prescribed for needlestick while working in hospital, has 2nd needlestick on 20Jul90
Severe headache, fever. But after fever came down with Tylenol, patient continues to sleepwalk. At one point he believed he?s possessed, hallucinating, and wanted to jump out the window.
12/30- possible exposure to COVID (+) med student 1/5- tested negative  1/8- tested negative, went to clinic and was diagnosed with a head cold, BP elevated 1/9-1/10- had 100.1. fever, lethargic, high BP, lymph nodes swollen 1/12- BP uncontrolled, Increased metoprolol to 2 pills instead of 1 1/15- noticed pressure on L side of neck, temp higher on this side compared to right 1/17- L earache, decreased hearing, feels clogged, pain  intermittent
Received influenza vaccine in a.m. After lunch, noticed slight burning/tingling sensation to skin. Didn't notice any rash. No itching. Arrived home about 5 p.m., changed clothes and noticed rash on chest & shoulders (like "red lace"). Took Benadryl 50mg and was less red in a few hours. This has never happened after a flu shot before.
A non-serious spontaneous report of we administered expired H1N1 LAIV was received from a health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Extremely sore joints, particularly shoulder; Profound fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose bnt162b2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included allergies extensive. Concomitant medication included thyroid, metformin and celecoxib (CELEBREX). The patient experienced on 11Feb2021 07:00 Extremely sore joints, particularly shoulder. Profound fatigue. The outcome of the events unknown.