chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Proper nursing procedures not following and patient received the incorrect vaccine. Pt received a 3rd dose of shingrix when only 2 doses is recommended. Pt was observed and suffered no harm from the extra dose. The vaccine not received will be rescheduled. Reporting since error involving a  vaccine. No harm to patient.
She got her vaccine, 24 hours later she woke up with her skin tingling and she has a burn  under her left eye.  She has not felt well at all, sick, almost like she has COVID.  She saw her doctor and that it was a reaction to the vaccine.   She has a massive headache, diarrhea, cold chills to the point that she could not get warm, thought problems.   Has not been able to work due to these symptoms.    She has a very sensitive immune system, and told Occupational health and she was denied an exemption.  She works at Hospital and it was mandatory to take the vaccine.    She has been itching all over.  Her doctor told her to use St. Ive's Aloe Vera, OTC, which has helped some.
Favoring right leg walking with limp not letting anybody touch it. Pt is fussy but consolable, no fever.
Information has been received from a mother concerning her daughter, a 23 year old female with penicillin allergy and "cold medicines" allergy and a history of bipolar and shaken baby syndrome who on 10-JUL-2008 was vaccinated with the first dose of GARDASIL.  (Dose, route of administration and lot number were not provided).  Concomitant therapy included SEROQUEL, LEXAPRO and TEGRETOL.  The patient felt faint after the vaccination.  Two days later her throat began to swell and was sore.  The mother reported "Her throat was so swollen that she could not eat cereal."  The patient also had a red face, fever and was nauseous.  The patient sought medical attention via telephone.  She started taking BENADRYL on 16-JUL-2008.  Her symptoms were improving since starting the therapy with BENADRYL.  Additional information has been requested.
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association.   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 RA, IEC, as appropriate.
Pregnant female was given Live H1N1 nasal vaccine. MD notified (obsetrician) 10/21/09. Pt started TAMIFLU within 24 hrs of vaccine.
Diagnosis of covid (despite negative test); Diagnosis of covid (despite negative test); Fever; Chills; Exhaustion; Body aches; Stomach ache; Diarrhea; Coughing; Headache; Short of breath; Elevated blood pressure; This is a spontaneous report from a contactable consumer (reporting for herself). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 08:45 (Batch/Lot Number: EN8730) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 (lot number: EN6206, administration time: 08:45 AM) for COVID-19 immunization. On 18Apr2021 at 12:00, the patient experienced fever, chills, exhaustion, body aches, stomach ache, diarrhea, coughing, headache, short of breath, elevated blood pressure.   The patient underwent lab tests and procedure which included 2 negative COVID tests on 19Apr2021 and 23Apr2021 respectively and flu test: negative on an unspecified date. The patient was diagnosis of COVID (despite negative test) received on 23Apr2021. The events resulted in emergency room/department visit or urgent care. The patient did not received treatment for the events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
RUNNY NOSE; SORE THROAT; EAR PAIN; COUGHING UP WHITE PHLEGM; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced runny nose. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced ear pain. On 14-APR-2021, the subject experienced coughing up white phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from coughing up white phlegm, and had not recovered from runny nose, sore throat, and ear pain. This report was non-serious.
The day of I had a normal sore arm. A week later I noticed a lump in my arm pit. I t was the size of a golf ball. It caused naprapathy down my arm into my rib cage. It continued for about 3 weeks. I could barely move my arm I put my arm in a sling because it was hurting so bad.
Pt received shot in left arm. 12/9/03 AM, pt felt symptoms begin: sore throat, chest wheeze, no appetite.
Lymphadenopathy (Axillary, Left Groin, Submandibular)
Information has been received from a registered nurse concerning a female (age unknown) who, on an unspecified date "a while back", was vaccinated with a dose of ZOSTAVAX. Subsequently, "a while back", the patient developed severe redness. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of two reports relieved from the same source.
PM after receiving vaccine, he had chills, vomiting, panic attack and shortness of breath. Resolved the next morning.
Breakthrough  case infection after 2 vaccines  Moderna 2/9/21 lot# 007M20A; Moderna 3/9/21 lot# 010A21A;
Pain in left shoulder/arm (injection was to left arm). Not sore to the touch, but painful to lay on, esp first night. 4 weeks later, still some pain when laying on it and ALL THAT TIME sharp pain when reaching behind my back. [Shoulder injury related to vaccine administration (SIRVA)].
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 3:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 3:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 59.98 for dose administered on 12-Jan-2021.  No concomitant medications were reported.  This vial was moved to fridge on 08-Jan-2021. Product moved to clinic on 12-Jan-2021. Batch number 041L20A underwent temperature excursion on 12-JAN-2021  with temperature 34 degrees Fahrenheit at 08:00 AM and 09:00 AM. Beyond use date for the vial was reported as 07-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
dx of covid 19; dx of covid 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 79-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "nonrheumatic AV insufficiency" (unspecified if ongoing); "nonmelanoma skin cancer" (unspecified if ongoing); "cataracts bilaterally" (unspecified if ongoing); "Rosacea" (unspecified if ongoing); "AK" (unspecified if ongoing); "mitral regurg" (unspecified if ongoing); "HLD Aneurysm of aorta" (unspecified if ongoing); "HLD" (unspecified if ongoing); "thyroid nodule" (unspecified if ongoing); "essential hypertension" (unspecified if ongoing); "Known allergies: grasses" (unspecified if ongoing); "Known allergies: Trees" (unspecified if ongoing); "Known allergies: Ragweed" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "dx of covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative, notes: Tested negative for covid on 23Jun2022; (23Jun2022) Positive, notes: Repeated home test that was positive for Covid on 23Jun2022; (23Jun2022) Positive, notes: Repeated home test that was positive for Covid on 23Jun2022 and also from spit test at the (Lab name withheld) that same day. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Symptoms started on 16Jun2022 and dx of covid 19. Started paxlovid on 17Jun2022 and took until gone on 22Jun2022 and felt just a bit of residual symptoms with great improvement. Tested negative for covid on 23Jun2022 and then on 25Jun2022 started to develop new mild symptoms of cough, increased phlegm in chest and nasal passages, resurgence of fatigue. Repeated home test that was positive for Covid on 23Jun2022 and also from spit test at the (Lab name withheld) that same day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
No additional adverse events reported; administration of improperly stored PROQUAD.; This spontaneous report was received from a physician who refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-AUG-2021, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, recombinant human albumin (rHA) (lot # U006314, expiration date: 24-AUG-2022) (strength and route of administration were not provided) for prophylaxis. No adverse events were reported. According to the reporter, the temperature excursion was 45.3 degrees Fahrenheit for a time frame of 17 hours on an unspecified date, without any previous temperature excursion.
wheel was missed first attempt left arm and was re administered two inches away on L arm. No adverse reaction noted
Very mild malaise type of feeling; A little bit out of it; Feeling of tiredness; Soreness at the injection; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Very mild malaise type of feeling), FEELING ABNORMAL (A little bit out of it), FATIGUE (Feeling of tiredness) and VACCINATION SITE PAIN (Soreness at the injection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Hypothyroidism, BPH, Sleep apnea, Monoclonal B-cell lymphocytosis (MBL (Monoclonal B-cell Leukocytosis) which he sees a hematologist for) and Atrial fibrillation. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), FLECAINIDE, AMLODIPINE BESILATE (NORVASC), TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Very mild malaise type of feeling). an unknown date, the patient experienced FEELING ABNORMAL (A little bit out of it), FATIGUE (Feeling of tiredness) and VACCINATION SITE PAIN (Soreness at the injection). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Very mild malaise type of feeling), FEELING ABNORMAL (A little bit out of it), FATIGUE (Feeling of tiredness) and VACCINATION SITE PAIN (Soreness at the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication included put some hydrocortisone cream on it and some CBD cream.  The lot number for the first dose was 025J20A OR 02C120A.   This case was linked to MOD-2021-297029, MOD-2021-297112 (Patient Link).
Primary reporter reports the administration of one dose of an improperly stored vaccine, PROQUAD; No adverse effects reported for the patient; This spontaneous report was received from a vaccine coordinator, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 30-OCT-2019, the patient was vaccinated with one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S017243 with expiration date on 01-DEC-2020 (exact dose and route of administration were not reported) for prophylaxis. It was reported that the vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were unknown).  Administered dose of vaccine experienced temperature excursion of -4.6 degrees Celsius for 1 hour and 1 minute. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported for the patient.
Patient was supposed to recieve 2nd Moderna Vaccination. Patient instead recieved Johnson & Johnson vaccine.  Patient was scene by the EMS onsite. Patient was watched for 15 minutes and showed no after vaccination symptoms before released.
I was having some foot pain; amputated to my lower right leg/chopped my leg; blood clot; This is a spontaneous report from a contactable consumer (patient) reporting herself.  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: ER8730, expiry date: unknown), via an unspecified route of administration, administered in right arm on 12Apr2021 (at the age of 56 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included cervical cancer stage IV from Jun2019 and thyroid disorder unknown if ongoing. The patient had no prior vaccination. Historical vaccine includes first dose of BNT162B2 (lot: EN6208/expiration: unknown) via an unspecified route of administration administered in left arm on an unspecified date for covid-19 immunisation. The concomitant medications included levothyroxine and pembrolizumab (KEYTRUDA) on an unspecified date. April about three weeks after the second shot; i didn't know I thought it was just a foot ache and it didn't get bad until i went into the hospital and they couldn't save my leg and they amputated my right leg. I had blood clot and caused chopped my leg. Consumer stated, I started in April, but i can't remember the exact date, I start having foot pain until 10May2021 and I realize that it was something serious and went to the hospital. I am trying to report that I had Pfizer second vaccine and after that I had a blood clot, and I lost my leg. I am trying to report it to let you guys know because I know you keep record on that, but I had a blood clot that amputated my right leg. The patient was caused/prolonged hospitalization in ICU for the events from May2021 to an unspecified date. The patient had several unspecified lab tests on an unspecified date for which results were unknown. On 10May2021, the patient was treated with blood thinner and a bunch of things for events. Outcome of the events was unknown.  Follow-Up (13Jul2021): Follow-up attempts are completed. No further information is expected.
Headache, Arthralgia, Fever, FATIGUE, CHILLS, PAIN/SWELL INJ SITE Narrative:
Received Pfizer vaccines on  5/14/21, 6/7/21 COVID-19 positive by PCR on  1/9/22 admitted to hospital on 1/9 d/t suicidal ideation, incidentally COVID positive
Vertigo when laying down; varies from mild to severe; first appeared 1 week after initial shot.  Saw physician about 1 week later and diagnosed as BPV and prescribed physical therapy.  After several sessions noted some improvements but after 2nd shot worsened
Reported as large, red, hot, "lump" on upper (R) arm x 2 days after KINRIX injection.
Started around 11 am 2-16-2021 and progressively worsened over course of 5 hours.  Nausea, headache, body aches, chills, fatigue, breast soreness, and muscle weakness.
Aprox 12 hours later with hives and taken to ED given Benadryl and sent home followed up today still mild diffuse hives flat not raised and faint. Much better per parents.
My son woke up on 5/3/16 with a red measles like rash to his trunk and neck. It spread to his arms and cheeks on 5/3 and 5/4/16. It had resolved by 5/6/16. Rash was itchy. BENADRYL used for symptom management.
Information has been received from an RN concerning a female patient who on approximately 06-APR-2007 was vaccinated with her first dose of Gardasil.  The day after receiving the injection the patient's arm turned red, swelled, and was itchy.  Her arm was red from the injection site to her elbow.  Unspecified medical attention was sought.  The patient treated herself with diphenhydramine hydrochloride (BENADRYL).  Her symptoms lasted seven days.  The patient's outcome was reported as recovered, date unknown.  Additional information has been requested.
After receiving dose one of covid 19 vaccine on 3/19/21, patient experienced a tonic clonic seizure on 3/21/21 at 2pm.  After receiving dose two of covid 19 vaccine on 4/8/21, patient experience a different kind of seizure on 4/10/21 at 11pm.    Patient has history of epilepsy but is controlled and has not experienced a seizure in many years.  the adverse even occured approx 2 days after each dose.  Follow-up with Neurologist has determined that most likely the immune response to the vaccines triggered the seizures.  Patient had EEG and has appointments for more testing including MRI.
The needle was not all the way tight on syringe and some vaccine dripped out during administration. Most of the dose is believed to be administered.
Soreness at the injection site. Taking an NSAID to help treat the soreness. Outcome: soreness is persisting. NSAID helps.
Around 8 days post-first-injection, swelling and redness around injection site, muscle pain, warm skin. Irritated area grew from about 6cm x 2cm to about 10cm x 10cm over the course of a few days. Pain and redness persisted for about four or five days, then began to subside, though skin in that area remained warm. After about a week or so redness faded, and pain was replaced by itching. Warm skin persisted. After about two weeks, patch fully disappeared, skin returned to normal temp, and itching largely subsided.
pt recv vax 23OCT98 & that noc pt devel a fever & was taken to ER & released;24OCT98 pt exp pain in rt leg & was seen by MD;lab test revealed WBC count of 15,000;dx w/rt leg osteomyelitis;
caused INR (blood thinner warfarin) level to go from 2.5 to 4.0
Subsequent to vax, the pt learned that she had become pregnant at approximately the time of vax. On 03/02/1998, the pt gave birth to a female who was dx with microcephaly as an infant and with mental retardation in 1999. The infant sought unspecified medical treatment. Additional information has been requested.