chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received both the doses of Shingrix 2 years ago from the date of reporting. After receiving Shingles vaccine, the patient contracted shingles 2 week ago from the date of reporting. the reporter was not 100 percent sure if the patient got Shingrix but thought so. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles were not provided.
PATIENT FAINTED  AND  ONCE HE CAME TO FELT CLAMMY. HE DID NOT EAT ANYTHING ALL DAY
This case was reported by a pharmacist via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, headache and influenza-like symptoms. On an unknown date, the outcome of the pain, headache and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain, headache and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: GlaxoSmithKline representative called to report two adverse events on SHINGRIX.  The pharmacist told GlaxoSmithKline representative that he had two patients with severe flu like reactions after having the first dose of SHINGRIX. The patient stayed in bed for 2 to 3 days, missed 3 days of work and would not be receiving the second dose of SHINGRIX. The symptoms were pain, headache, general flu like symptoms. One case happened during the summer and the other one two months before the date of reporting. It was unknown which of the two reports happened during the summer or two months before the date of reporting. There were no additional addresses listed for initial reporter. The reporter did not have a phone number for pharmacist. This case has been linked with the case US2018203979, reported by same reporter.
I did not have any soreness, no reaction to the vaccine. I had a home test for COVID-19, and it was positive. I had fatigue, running nose, cough. After my test, I waited 5 days, I called and talked to the nurse, because I still getting positive results. She said to isolate for 5 days, wear a mask if I go out, I have been feeling better and continue wearing mask.
pt recv vax; fever 103 27jun95; 28jun95 CBC done, WBC=11.7; chest x-ray revealed lt upper lobe pneumonia; adm to hosp;
This spontaneous report as received from a physician concerning a female patient in her 50's age with no drug reactions or allergies reported. The patient's medical history included herpes zoster. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The physician reported that patient had two more cases of shingles since receiving the vaccine, on an unknown dates. It was reported that the patient received unspecified treatment. The outcome of herpes zoster was reported as recovered.
Metallic taste in mouth, starting hours after injection, lasting approx. 8 hours Headache, starting hours after injection, ongoing Muscle ache, starting hours after injection, lasting 3 days Joint pain, starting hours after injection, lasting 3 days Night sweats, starting 2 days after injection, ongoing
Four hours after vaccine, patient developed rash to both arms, gradually spreading to upper and lower arms and right thigh.  A  little less than 48 hours later, also began to develop chest tightness and throat tightness with difficulty swallowing.
Initial misuse report received from a healthcare professional (nurse) on 25 September 2013 and the case was received on 21 March 2014 at GPV. A 04-month-old patient had received a dose of 0.25 ml of FLUZONE (batch number, route, dose in series and site of administration as not reported) on an unspecified date. List of documents held by sender: none
I was diagnosed with shingles. I was prescribed a week's worh of Famvir, an antiviral.
Information has been received from a physician concerning a 12 month old female who on 26-APR-2007 who was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of varicella virus vaccine live. The physician reported that the practice ordered varicella virus vaccine live and zoster vaccine live was sent by the pharmacy. The vaccine was put in the freezer where varicella virus vaccine live is normally kept and the medical assistant administered the vaccine assuming it was varicella virus vaccine live. The medical assistants will now be double checking all medications prior to administration. As of 07-JUN-2007 the patient was fine, there was no fever or rash. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
PT HAD 20 SECONDS EPISODE WHERE PT WENT BLUE, ARMS WENT LIMP AND PT NON RESPONSIVE. PT THAN IMMEDIATELY BEGAN CRYING.
Right arm hurts, after booster; Tremors, shakes in right hand, only in the morning, after  booster; Weakness in right arm, from shoulders to fingers, after booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 (Lot number: FP25Q) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for psoriatic arthropathy (ongoing); HYDROXYCHLOROQUINE; OTEZLA; FLU VACCINE VII, start date: 13Oct2021, stop date: 13Oct2021. Vaccination history included: Bnt162b2 (Dose: 01, Time: 10:00 AM, Anatomical site of injection: Left arm, Batch number: ER8733, Exp: Jul2021), administration date: 26Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose: 02, Time: 10:00 AM, Anatomical site of injection: Left arm, Batch number: EW0158, Exp: Jul2021), administration date: 16Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Oct2021, outcome "recovering", described as "Right arm hurts, after booster"; TREMOR (non-serious) with onset 2021, outcome "recovering", described as "Tremors, shakes in right hand, only in the morning, after booster"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "recovering", described as "Weakness in right arm, from shoulders to fingers, after booster."  Additional information: It was reported that, lot number FP25Q or it could be FPCSQ. No emergency room, AE(s) following prior vaccinations, relevant tests and physician office. Family medical history relevant to AE(s) was not provided. The A/E was going away. Not an issue now. It was constant on and off since injection. Seems to be subsiding now.  No follow-up attempts are possible. No further information is expected.
12/10/15 he got vaccinated, 6 days later 12/16/15 started getting congested 2 days later 12/18/15 was congested with fever of 103.00 would not and could not breastfeed and was throwing up milk and phlegm. 12/18/15 went to doctor's, sent us home said it was the flu. 1 day later 12/19/15 went to ER since the symptoms were getting worse, they sent us home said it was the flu. 12/20/15 took him back to ER fever was 103.2 still symptoms and they admitted him for positive RSV.
diagnosed with Bell's palsy; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration in left arm on 19Dec2020 10:00 at single dose for COVID-19 immunization. No other vaccine administered in four weeks. Medical history included drug sulfa allergy. Concomitant medication included cetirizine, cetirizine hydrochloride (ZYRTEC) from 18Dec2020, and multivitamin from 18Dec2020. No Covid prior vaccination. No Covid tested post vaccination. About 40 min after the vaccine (19Dec2020 10:40) the patient developed left facial/ left tongue tingling/ numbness. By 20:30 at night (19Dec2020 20:30), the patient had a left sided facial droop as well, the patient was diagnosed with Bell's palsy. 20:30 (19Dec2020), she had facial asymmetry. She looked in the mirror and noticed her smile was not symmetrical. She then checked into the Emergency Room and the ER doctors diagnosed her with Bell's palsy. She was not admitted to the hospital. Steroids were given for treatment. The patient was still expirencing. Intermittent tingling but tingling was not constant. Smile was not normal yet. The outcome of event was not recovered.; Sender's Comments: Based on the close temporal relationship, the association between the event Bell's palsy with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Approx. 1 day after last IZ's were given, had white, chalky and yellowish liquid stools. Slight fevr for 24 hours. Parents claim stool continued to be irregular for a few months. Child tested. Liver panel and other labs negative. Mother is Hep C (+), child tested negative results.
1025PM pt mom took pt to ER upon arrival skin pink, resp non labored, asleep in carrier;pt woke up screaming from nap & began gasping for air, eyes rolled back & shook all over;
Developed shingles; neuropathy in hands and feet became chronic; neuropathy in hands and feet became chronic; Experienced mild numbness in hands and feet; Immediate metal taste in mouth after both doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2021 as dose 2, single (Lot number: EW0162) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: BNT162b2 (prev dose brand unknown=False, is bivalent= False, prev dose lot number= ER8727, prev dose lot unknown= False, prev dose administration date= 29Mar2021, prev dose dose number=1, prev dose vaccine location=Right arm, Immediate metal taste in mouth after both doses), administration date: 29Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "metal taste in mouth"; Shingrix (I had had Shingrix vaccine 2 dose in Jan2019), administration date: Jan2019, when the patient was 58 years old, for Immunization. The following information was reported: DYSGEUSIA (disability) with onset Apr2021, outcome "recovered with sequelae", described as "Immediate metal taste in mouth after both doses"; HYPOAESTHESIA (disability) with onset 14May2021, outcome "recovered with sequelae", described as "Experienced mild numbness in hands and feet"; NEUROPATHY PERIPHERAL (disability), CONDITION AGGRAVATED (disability) all with onset 14May2021, outcome "recovered with sequelae" and all described as "neuropathy in hands and feet became chronic"; HERPES ZOSTER (disability) with onset Aug2021, outcome "recovered with sequelae", described as "Developed shingles". The events "immediate metal taste in mouth after both doses", "experienced mild numbness in hands and feet", "developed shingles" and "neuropathy in hands and feet became chronic" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jan2022) Positive; (29Dec2021) Negative; (03Jan2022) Negative. Therapeutic measures were taken as a result of dysgeusia, hypoaesthesia, herpes zoster, neuropathy peripheral, condition aggravated.  Clinical information: Patient did not took any other vaccine in four weeks. Other medications in two weeks: Ibuprofen 200mg. She was not having covid prior to vaccination and tested positive post vaccination. Immediate metal taste in mouth after both doses. She experienced mild numbness in hands and feet about 1 month later. Developed shingles 4 months later in Aug2021 (had Shingrix vaccine 2 dose in Jan2019) treated with antiviral and recovered but neuropathy in hands and feet became chronic. She received treatment of valACYclovir HCl 1 GM for adverse event. No known allergies were reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201399442 similar report from same reporter;
Reports 3 days after vaccine, developed sweating, palpitations, nausea and headache. Was hospitalized x 2 days 2/8/21-2/10/21. Currently under treatment with PCP, MD and, NP.
Shortness of breath; massive multiple pulmonary embolism; 3rd pfizer injection; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 14:45 (Lot number: 30135B) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation in Clinic. The patient had no relevant medical history. Notes: Other medical history: No. Known allergies: No. The patient's concomitant medications were not reported. The patient didn't take other medications in 2 weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown, Location of injection: Arm Left), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left), for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 post vaccination. The following information was reported: IMMUNISATION (hospitalization, disability, life threatening) with onset 27Sep2021 14:45, outcome "not recovered", described as "3rd pfizer injection"; DYSPNOEA (hospitalization, disability, life threatening) with onset 04Oct2021(also reported as 7 days after vaccination), outcome "not recovered", described as "Shortness of breath"; PULMONARY EMBOLISM (hospitalization, disability, life threatening) with onset 04Oct2021(also reported as 7 days after vaccination), outcome "not recovered", described as "massive multiple pulmonary embolism". The patient was hospitalized for dyspnoea, pulmonary embolism (hospitalization duration: 6 days). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Oct2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of dyspnoea, pulmonary embolism.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Immunisation, Dyspnoea, Pulmonary embolism and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Was very ill after the vaccine; 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 ILLNESS (Was very ill after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was very ill after the vaccine). At the time of the report, ILLNESS (Was very ill after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
This case was reported by a other health professional via call center representative and described the occurrence of upper respiratory tract infection in a female patient who received RABAVERT. On 15th May 2017, the patient received the 2nd dose of RABAVERT (intramuscular) 1 ml. On 26th May 2017, 11 days after receiving RABAVERT, the patient experienced upper respiratory tract infection. The patient was treated with methylprednisolone, methylprednisolone, MEDROL DOSEPAK. RABAVERT was continued with no change. On 31st May 2017, the outcome of the upper respiratory tract infection was recovered/resolved. The reporter considered the upper respiratory tract infection to be unrelated to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The date of birth of patient was unknown. The case was a pre-exposure vaccination case of RABAVERT. The upper respiratory infection resolved without sequelae after treating with a course of MEDROL DOSEPAK. The case was reported by veterinary assistant.
3:25pm nausea & vomiting,  flushed face with fine rash. Pt administered Benadryl 50mg ivp,  Solu Medrol 125mg IVP,  & Oxygen 2L/nasal cannula.  At 5:15 pm patient was stable, all symptoms resolved and discharged home stable.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ATORVASTATIN, VALSARTAN, FAMOTIDINE, CETIRIZINE, FINASTERIDE, ATENOLOL, HYDROCHLOROTHIAZIDE, CALCITRIOL, APIXABAN and GABAPENTIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (Itching all over the body). At the time of the report, PRURITUS (Itching all over the body) had not resolved. Not Provided      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.   The treatment information was None + concomitant.
Warm autoimmune hemolytic anemia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of AUTOIMMUNE HAEMOLYTIC ANAEMIA (Warm autoimmune hemolytic anemia) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTOIMMUNE HAEMOLYTIC ANAEMIA (Warm autoimmune hemolytic anemia) (seriousness criterion medically significant). The patient was treated with RITUXIMAB for Autoimmune hemolytic anemia, at an unspecified dose and frequency; MYCOPHENOLATE MOFETIL for Autoimmune hemolytic anemia, at an unspecified dose and frequency and IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for Autoimmune hemolytic anemia, at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE HAEMOLYTIC ANAEMIA (Warm autoimmune hemolytic anemia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood smear test: positive (Positive) Markers of hemolysis were all positive.. In April 2021, Coombs direct test: positive (Positive) Markers of hemolysis were all positive..     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.   Concomitant product was not provided by the reporter. Treatment for the event included Corticosteroids.    Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
having speech problems, it's not fluid; Sleeplessness; swelling and hurting for a couple of days after receiving Covid-19 vaccine; swelling and hurting for a couple of days after receiving Covid-19 vaccine; it might be her lithium that the Covid-19 vaccine might have interacted with; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation ,and  lithium (LITHIUM) , via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication .  Medical history included bipolar disorder.   The patient's concomitant medications were not reported.   The patient stated she was having speech problems, it's not fluid  , sleeplessness , swelling and hurting for a couple of days after receiving covid-19 vaccine all the event occurred on an unspecified date with outcome of unknown . The patient suspected a possible interaction  between her lithium and  the Covid-19 vaccine. The patient  didn't expect her psych meds coming up.  Information on the Lot/Batch number has been requested.
A notification was received from database regarding a vaccine administered to an inappropriate age.  On review of the data used at that time, the record had a documented date of birth of 2009.  The first and 2nd doses were administered on 8/13/2021, and 9/1/2021, and on review of records for the lot number, it was confirmed that the vaccine presentation administered was intended for 12+.  No signs or symptoms were reported related to the doses administered.   A booster dose of vaccine was administered to the patient by another provider on 7/13/2022.