chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a currently 65 years old female patient with milk, sugar and wheat allergy. It was reported that the patient presented shingles on an unknown date (Pertinent medical history also reported as none). In July 2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (dose, lot NO., lot expiration date, route and anatomical location of administration were not reported). The patient had no concomitant therapies. On an unknown date, the patient "got shingles, but had shingles prior to vaccination, and still has outbreaks". The patient sought medical attention and went to a clinic, nevertheless no laboratories were performed. The pharmacist stated that the patient received a prescription for Lidocaine on 17-JUN-2016. No Product Quality Complain (PQC) was involved. The outcome of the event was reported as not recovered. The causal relationship between the event and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
BODY ACHE; TINGLING SENSATION ON THE RIGHT SIDE OF TONGUE AND LIPS; SLIGHT NUMBNESS ON THE RIGHT SIDE OF TONGUE AND LIPS; ITCHY EYE; HEADACHE; BIG RED CIRCLE ON ARM; This spontaneous report received from a patient concerned a 31 year old. The patient's height, and weight were not reported. The patient's past medical history included bell's palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced big red circle on arm. On 08-APR-2021, the subject experienced tingling sensation on the right side of tongue and lips. On 08-APR-2021, the subject experienced slight numbness on the right side of tongue and lips. On 08-APR-2021, the subject experienced itchy eye. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling sensation on the right side of tongue and lips, slight numbness on the right side of tongue and lips, and itchy eye on 09-APR-2021, and the outcome of headache, body ache and big red circle on arm was not reported. This report was non-serious.
seven people she has talked to have referred getting headache since they got their shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "seven people she has talked to have referred getting headache since they got their shots".  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: Linked Report(s) : US-PFIZER INC-202300266655 same SD/AE, different patient;
After getting flu shot, FLUZONE High-Dose 2017-18 0.5ML. SYR I got diarrhea, muscle cramps in legs, headache. Needed to rest and sleep day after injection.
Per death certificate, pt died in a nursing home; condition contributing to the causes of death was COVID 19; Pt had a positive COVID test on 1/20/21.
Patient checked in to facility on 10/14/2022 requesting bivalent Pfizer vaccine. Medical Assistant took out the monovalent Pfizer vaccine from the fridge and Dr. did not visually inspect the vial and administered the vaccine. No adverse side effects reported.
Father states and mother validates that child started vomiting 4 hours following vaccinations.  Vomitted twice.  No fever.
Pounding frontal headache Muscle Aches Fatigue Loss of appetite -all started several hrs post vaccination
onset of severe weakness, motor & sensory disturbances on11NOV96;clinical cause & diagnostic walk-up;consistent w/GBS;
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received doses of improperly stored VARIVAX lot# M000756 with expiration date: 06-JAN-2018 (dose, route of administration and injection site were not reported). Administered doses of VARIVAX underwent temperature excursions at 12 Fahrenheit degrees, for 720 minutes. Previous temperature excursion was at 32 Fahrenheit degrees, for 750 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
a little achy feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 (Lot number: FF8839) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL9264, Anatomical Location: left arm), administration date: 30Jan2021, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: EN6205, Anatomical Location: left arm), administration date: 27Feb2021, for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "recovered" (2021), described as "a little achy feeling".  Follow-up attempts completed. No further information expected.
Acute onset Rt side ptosis. ? roseola right after vaccine started with fever and fussiness, she had atypical post MMR rash with ptosis fussiness and then had acute onset Rt sided ptosis on 8/26/14 in the evening. She was seen in our office on 8/28/14 and then admitted for rule out ADEM due to ptosis and fussiness - no treatment.
approx 24 after immunization, developed swelling, redness, pain to R arm at injection site, enlarging later in the same day to include area 3cm below shoulder to distal 1/3 of humerus, lateral upper arm, erythematous, firm subcutaneous lesion on exam with mild tenderness to palpation, prompted walk-in visit
Pt. states that after receiving the 3rd dose Booster of Phizer 09/16/2021, started experiencing symptoms 09/27/2021 of Vertigo when getting up for the day.  Lasting 1 minute. No noted Primary visit.
Started on 12/3/21 with patches of itchiness on scalp and neck, and progressively worsened over 3 days to swollen eye orbitals and hives on large parts of my body, including scalp, neck, chest, back, arms and legs.  Started with taking Benadryl, which helped for first 3 days, but on 12/6/21, I got blood work to check for autoimmune issues (all blood work was in normal range) and was prescribed a course of prednisone 60mg x 3 days, 50mg x 4 days, 40mg x 3 days, 20mg x 3 days, 10 mg x 3 days, also started taking famotidine 40mg daily, loratadine 10mg daily. After a week added: hydroxyzine 50mg twice daily and montelukast 10mg daily.  As of today 12/23, I still have patches of rash that comes and goes all over my body, and my skin is very sensitive (a minor bump/scratch will trigger a red raised rash response). Heat makes the rashes worse, and it is still responding to antihistamines so continuing on famotidine, loratadine, hydroxyzine and monelukast.
It appears the patient may of recieved a full dose of Moderna for a booster dose instead of a half dose.
Covid-19; Covid-19; This is a spontaneous report from contactable consumer. The reporter is the patient. A 72-year-old male patient received BNT162b2, on 14Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 05Feb2021 as dose 2, single (Lot number: EM9810), in right arm, on 14Sep2021 as dose 3 (booster), single (Lot number: FC3183), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis", non-symptomatic sarcoidosis; "known allergies to sulfa drugs". The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), drug ineffective (medically significant), outcome "recovering" and all described as "Covid-19". Therapeutic measures were taken as a result of covid-19, drug ineffective, which included Pfizer Paxlovid from 17May2022 to 22May2022.
Headache, Myalgia, NauseaVomiting, GastricBleeding, Body itching, mouth numbness, palm of hand numbness  Narrative: Employee reports that she when to the ER 3 times at the advice of her PCP due to the amount of pain she was having and the last time was today 10/15/2021 when she started vomiting blood, Unknown amount. She was treated and released.
NUMBNESS IN HANDS, FINGERS AND FACE; CONGESTION; SORE THROAT; DIZZINESS; CHILLS; WEAKNESS; FEVER; FATIGUE; NAUSEA; HEADACHE; MUSCLE PAIN IN BACK; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced numbness in hands, fingers and face. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced dizziness. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced weakness. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced muscle pain in back. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, weakness, fever, and headache on 10-MAR-2021, and had not recovered from fatigue, nausea, muscle pain in back, numbness in hands, fingers and face, congestion, and sore throat. This report was non-serious.
Patient reported to vaccine clinic to receive first dose of Pfizer Covid Vaccine.  After receiving vaccine patient was sitting in observation area.  Patient asked RN who was in observation area if it was normal to feel chest pressure after the vaccination.  RN took patient to ER for full workup for chest pain.  All labs within normal limits.  Cardiology was consulted.  Awaiting consult notes
Type 1 Diabetes Diagnosis in mid-February 2022 Symptomatic up to 2 months prior to diagnosis, following my third (booster) Covid vaccination  Was admitted in mid- February to the Emergency Room with high blood sugar levels, borderline keto acidosis, and ultimately was confirmed to have Type 1 Diabetes at 33 years of age.  Following my vaccination on November 30, 2021, I experienced periodic lapses in cognition, vision problems, lethargy, insomnia in which I was later diagnosed with Type 1 Diabetes.
20 month old baby received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Sept-2022 Reporter's comment: The facility address of the incident (did not collect that address) was different from the mailing address. The reporter consented to follow-up. Additional supportive information: The patient (20 months old) received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
I started experiencing altered taste after my second Covid shot. It first appeared as a reaction to ?hot sauce?. Commonly found when eating buffalo wings and sushi. I thought maybe I was developed an allergy to cayenne pepper.  My tongue would become inflamed and small blisters would erupt on my tongue. This local reaction continues to this day. However I am now experiencing changes in taste with just about every meal. It feels like I?m eating cardboard.
This spontaneous report as received from a health professional refers to a 12 month old patient. On 30-JUN-2014 the patient was vaccinated with a dose of M-M-R II (HSA, lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
20 minutes after shot felt stinging in middle of forehead and then quickly followed by numbness tingling ( felt like I had novocaine from dentist) down the left side of my face. 30 minutes after that my throat started to swell; breathing remained okay, so I just self monitored.  Throat swelling went down about 10: 00 PM; facial tingling/numbness also got better and is just very slight the next morning.
A non-serious spontaneous report of H1N1 inadvertently administered to a 17-month-old male was received from a registered nurse/health professional. The patient was not having any relevant medical history and concomitant medications. The patient received H1N1, Intranasal on 05-Nov-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved. Additional information was received on 18-Nov-2009 and incorporated into the narrative: event verbatim changed, information on medical history and concomitant medication.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided.  In March 2017 (reported as "from 06-MAR-2017 to 27-MAR-2017"), some patients were vaccinated with VARIVAX (lot #: M040137 with expiration date: 28-SEP-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. On 31-MAR-2017, some patients were vaccinated with VARIVAX (lot #: M042858 with expiration date: 21-OCT-2018) (dosage schedule, route of administration and anatomical location were not reported), also for prophylaxis. According to the reporter, VARIVAX doses were exposed to the following temperature excursions: 8 hours between 6 degrees Fahrenheit (F) and 14F (-14 degrees Celsius (C) to -10C), 13.5 hours between 15 F and 46 F (-9C to 8C), and 28.5 hours between 47F and 77F (9C to 25C). A digital data logger was involved. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001065: US-009507513-1704USA001066: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001070: US-009507513-1704USA001064: US-009507513-1704USA001067: US-009507513-1703USA012554:
missed window for second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed window for second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed window for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed window for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
02:15 Pm---Pt received vaccine 02:38 Pm--pt reported dizziness and light headedness  to the LVN  02:44 Pm-- bp 144/80, P=115, R26, O2 sat=97%.   02:47 Pm---Reported Adverse effect to me.   02:48 Pm--Pt laid down.   Pt sipped and finished a cup of water.  02:57 Pm--bp=122/84, p100, r16,  O2 sat 98% 03:07 Pm---Pt reported that dizziness and light headedness resolve.  Stated that she experienced the same effect on her first dose.  03:08 Pm ----Pt was discharged.  Ambulated with no assist.  Verbalized that she was no longer feeling dizzy or light headedness.
ACUTE RESPIRATORY FAILURE 7/16/2021 LACTIC ACIDOSIS, UNSPECIFIED
pt recvd 1st dose of Hep B vax on 31JAN92 & exp pain @ inject site; pain persisted for a few seconds;
When first given injection, felt "zinger" go up left arm into neck area. In the days following injection, had pain, tightness, tense feeling in left neck and arm area.
Swollen painful supraclavicular lymph nodes.; Swollen painful supraclavicular lymph nodes.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The medical history included stomach ulcers and allergy to medical adhesives. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 21Apr2021 at 08:00, the patient experienced swollen painful supraclavicular lymph nodes. It was reported that the swelling was noticed about 7 days after vaccination and was present at the time of report (12 days after vaccination). The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen painful supraclavicular lymph nodes was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Weakness-Severe, Additional Details: Patient reported a history of \"passing out\" with injections. Pt experienced diaphoresis and dizzyness immediately following injection. Two to three minutes later she said she was feeling better. Five minutes after dose, she began to present with seizure symptoms; blank stare, arms and hands contracting. First seizure lasted 30 seconds. One minute later, her second seizure began(45 seconds) with the same sytmptoms, plus convulsions. We transferred her to the floor and on her side. VSS. EMS called
Flu-like symptoms; They felt sick; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (They felt sick) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (They felt sick). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (They felt sick) outcome was unknown.            Concomitant and treatment medications were not provided.  The patient stated that her friends got the Moderna booster and they both got flu-like symptoms. They felt sick. Patient wanted to know if that's possible. Then the patient changed her mind - she said that she wasn't sure if her friends got the Moderna or another vaccine.
Pain at the injection site; Fatigue; Patient ID:     Investigator Site:   Case reference number MOD-2021-008928 is a clinical trial case report which refers to a 76 Years old Female patient.  The patient experienced Pain at the injection site which resulted in .  This occurred while participating in Protocol   -   .  The patients relevant medical history included: No adverse event   The following drugs are known to have been taken by the patient prior to the event: AMLODIPINE[] ,SIMVASTATIN[] ,LOSARTAN[] ,EVISTA[]  .  The patients started Moderna COVID-19 Vaccine on  .  Some  1 day  later, the patient developed Pain at the injection site.'  Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:   The eventual diagnosis made was Vaccination site pain .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . The event(s) were:  Pain at the injection site - Unknown,Fatigue - Unknown. An autopsy was performed on  . .  The investigator considered the Pain at the injection site  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included <STATE ALL OTHER FACTORS> and the patients age/history or other factors <LIST OTHER RELEVANT FACTORS>; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reports "passing out" around 0400 at home. Patient arrived at work and fainted again. This resulted in ER visit.
Initial report was received 28 July 2011 from a health care professional. A female patient (age not reported) had received an injection of ADACEL (lot number, route, site and date of administration not reported) and shortly after vaccination, she was confirmed with pertussis. No additional information was provided at the time of the report. Documents held by sender: None.
Hysterical ear-piercing screaming and crying fits throughout the day. Hysterical ear-piercing screaming crying fits during the night accompanied by clenching of fists, arching back, and shaking of arms like in extreme pain. Fits lasting up to 1 hour or more in length each time. Black and blue circles under eyes, loss of appetite, and loss of drinking appetite. He will put hand up to head as if having pain in his head and will let out a scream and cry.