chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Today, 09JUL2201, wakes up and there is a little allergy, like little pimples around.; Today, 09JUL2201, wakes up and there is a little allergy, like little pimples around.; The day after receiving the vaccine, had a little ball in the area where the vaccine was given; a rash/itching in the area of the vaccine injection; a rash/itching in the area of the vaccine injection; This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported for a 66-year-old female (patient) reported that: A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller was a consumer who called regarding her mother, the caller's mother received the first dose Pfizer COVID 19 vaccine two days ago, 07Jul2021 at the "PRIVACY" Hospital. The callers mother has a reaction to the first dose Pfizer COVID 19 vaccine and the caller wants to make sure it was okay and part of the reaction to the Pfizer COVID 19 vaccine. On 08Jul2021, the day after receiving the first dose Pfizer COVID 19 vaccine, the callers mother got a little ball in the area where the patient received the first dose Pfizer COVID 19 vaccine and a rash/itching in the area of the vaccine injection. The caller states her language was kind of bad. The patient put ice and lotion on, like when "you" are working out. The patient's little ball in the area was getting better. "Today", 09Jul2021 the patient wakes up with a little irritation a little allergy little pimple around. The caller has never seen this reaction. The caller's husband said maybe the caller should call Pfizer. The caller stated her mother does not have a doctor and came to visit the caller, no doctor or anything. The caller would like to know if these reactions are part of the Pfizer COVID 19 vaccine, this irritation the patient was having. The outcome of "vaccination site mass" was reported as resolving and rest of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I got up around 8:30 , went to the toilet, and as I was washing my hands, I blacked out.  I slipped to the floor and then vomited several times.  Fortunately,  I had not eaten since about 7 pm the night before, but I still expelled material.    Stayed in bed all day.  Drank lots of water and slept.    FEEL MUCH BETTER today....eating and vertical.  PS   After the first shot, I slept most of the next day, felt very achy, sweated, and had a headache.  Those symptoms disappeared after about 24 hrs.  BUT about a week after the first shot, I developed a large rash not on, but rather near the injection site.  It was itchy for a day or two, as well.    As I said, I feel much better today, but just thought you should know, especially because the fainting and vomiting are not listed as common reactions.    THANKS
Redness and swelling of an injection. Had DTaP thursday along with other immunizations. Mom said he had a low grade fever at home. Swelling is about 4" in circumferance, leg is warm to touch. Patient given Ibuprofen and Triamcinolone cream.
the itching sensation lasts for a minimum of 3-4 days; patient has not yet received the second dose; Lethargy; Chills; Fever; Flu-like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a elderly 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 1st dose of Shingrix (left arm) and the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pruritus (Verbatim: the itching sensation lasts for a minimum of 3-4 days), lethargy (Verbatim: Lethargy), chills (Verbatim: Chills), fever (Verbatim: Fever), influenza-like symptoms (Verbatim: Flu-like symptoms) and incomplete course of vaccination (Verbatim: patient has not yet received the second dose).  The outcome of the pruritus was not resolved and the outcome of the lethargy, chills, fever and influenza-like symptoms were resolved (duration 3 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pruritus, lethargy, chills, fever and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the pruritus, lethargy, chills, fever and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The patient reported that he received the first dose of Shingrix about 1 year ago from reporting.  The patient had not yet received the second dose and after receiving the first dose of Shingrix, the patient experienced flu like symptoms, fever, chills, and lethargy which last about 2 - 3 days.  About 1 month after receiving Shingrix, the patient experiences itching sensations on the back, in the area of the right shoulder blade.  This itching sensation comes and goes, with an interval of a few weeks, and the itching sensation lasts for a minimum of 3-4 days.  Till the time of reporting, the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2023118062 same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023118062:1st report
Right arm pain since flu injection in right arm. Keeping her awake at night. Unable to reach above the head. Seen in urgent care on 4/2/2018, provider noted the skin at the site of injection, mild warmth, redness. Decreased ROM to Right arm. She was prescribed a 10 day course of BACTRIM antibiotics and FLEXERIL 5mg every 8 hours as needed.
hot flashes day and night; experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect). At the time of the report, HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.            No concomitant medications were reported  No treatment information was provided
Patient presented to the ED on 2/2 and 3/20, and presented to ED and subsequently admitted on 3/22.
This spontaneous report as received from a Medical Assistant refers to an unspecified patients of unknown age and gender. On an unknown dates, the unspecified patients were vaccinated with doses of improperly stored ROTATEQ oral (dose was not reported) lot # K016263, expiry date 26-JUN-2016. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
No adverse event; first dose 21-Apr-2021 second dose 26-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 21-Apr-2021 second dose 26-Apr-2021) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 21-Apr-2021 second dose 26-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-Feb-2023 to 19-Feb-2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 21-Apr-2021 second dose 26-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient received third dose of Moderna vaccine on 23-Nov-2021 with unknown batch number in right arm.  On 24-Feb-2023, the patient was experiencing Covid symptoms five days after finished her Paxlovid treatment and testing positive for COVID.
headache; chills; nausea; This is a spontaneous report from a non contactable consumer (patient). A 56-year-old female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration, on an unspecified date (at the age of 56-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got all of the side effects within twelve hours. The patient experienced headache, chills and nausea but refused to list her side effects stating that she reported her side effects to safety. Patient wanted to know what possible reason there could be that she got sick and stated is it an ingredient or all of the ingredients. Patient stated that she has not been this sick since she took the flu vaccine and also stated that some get sick and others do not. Patient went to the ER and got an IV. Patient stated she has been out of work and is not doing this again and will not take the second shot. Patient reported to the company and provided a repotum number and stated the I in the reportum number could be a 1. Outcome of the events was unknown.  No followup attempts are possible;Information on lot/batch number cannot be otained.
the patient experienced no symptoms; a shipment of Pneumovax23 was due to be delivered on 26-FEB-2020 but was not delivered until 27-FEB-2020. On 05-MAR-2020 a patient was administered a dose of pneumovax23; This initial spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not reported.  On 26-FEB-2020, a shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was due to be delivered, however, it was not delivered until 27-FEB-2020 (product distribution issue).  On 05-MAR-2020, the patient was vaccinated with one dose of the late shipment of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (strength, dose, route of administration and vaccination scheme were not reported; with lot number reported as S029542 which was confirmed to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) and expiration date reported and established as 10-JUN-2021) as prophylaxis. It was reported that the patient experienced no symptoms. No further information provided.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress:  manufacturercity: ; manufacturerstate:; manufacturercountry; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA005134: US-009507513-2003USA005469: US-009507513-2003USA005207: US-009507513-2003USA005195: US-009507513-2003USA005188: US-009507513-2003USA004971:
Had pia ( mini stroke ).In the hospital for two days and has blockage on both sides of her brain.
Patient was administered undiluted Pfizer 6mo-4yr Bivalent vaccine and was noticed after family left the office.  Staff notified Supervisor. Pfizer contacted. Dr. will be contacting family today to notify them of incident.
A 3-month old male received a dose of the Fluzone Quadrivalent, with no reported adverse event; Initial information received on 05-May-2021 regarding an unsolicited valid non-serious case received from a physician  via Other Health Care Professional.  This case involves a three month old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 05-May-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ559AC and expiry date: 30-Jun-2021) (Frequency once) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  It was also reported that nurse Manager states that they administered FLUZONE QUAD (Prefilled) to a 3 month old. Is there anything that they should do next other than report it. Reporter relationship: health care professional (HCP); Product used: used First time product used: yes still using product: no.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Erythematous, raised, warm, well circumscribed area at injection site. Rx: observation, Cephalein if worsening erythema, fever.
adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse event) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
A knot arose overnight at the vaccination site on my upper left arm.  The knot is very red.  The surrounding area is swollen, hot to the touch and very painful.  I woke up from the pain several times after midnight when I rolled onto my left side.  I do not plan to seek medical attention.
First shot was pretty normal, but also hollow chest feeling.; This is a spontaneous report from a contactable consumer (patient). A 48 years old non- pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6208, Expiry date was not reported) via an unspecified route, administered in Arm Left on 13Mar2021 at 12:15 (at the age of 48 years old) as Dose 1, Single for Covid-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history and concomitant medications within 2 weeks of vaccination were not reported. No known allergies were reported. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not received any other vaccine within 4 weeks. The reporter stated that, first shot was pretty normal, but also hollow chest feeling on 03Apr2021. The patient did not receive any treatment medication for resulted event. The patient underwent lab tests and procedures which included SARS-CoV-2 test negative on 29Mar2021. The outcome for the event was not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th August 2018, 1 days after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms, cold sores lip and injection site muscle pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the influenza-like symptoms, cold sores lip and injection site muscle pain were unknown. It was unknown if the reporter considered the fever, influenza-like symptoms, cold sores lip and injection site muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. It was not certain that this was a reportable event, and was discussed with GlaxoSmithKline adverse event (GSK AE) Liaison, but the patient reported that her granddaughter was touching her (the patient's) lip (with the cold sore) and experienced pain and blisters on her vaginal area and stomach. The patient's granddaughter was seen by her physician and was diagnosed as having a virus. The patient reported that she followed-up with her pharmacist.
Assessor and vaccinator did not realize that the patient was only 17 years old, and the Moderna vaccination was given. A call from the DPH was received by the pharmacy to notify us of the error. The patient's sibling (age > 18yo) was contacted since he spoke English. The sibling stated that patient did not have any side effects. I notified the family of the administration error, and they opted to continue with the 2nd dose as planned.
FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA057309 (CLUSTER) and 2023SA057733(CLUSTER).   This case involves adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error, latency: Unknown) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
I had a lot of fluid in my ears after contracting COVID. It felt like I had water in my ears. I lost my hearing for a bit. It lasted at least a week. It wag gurgling and swishing in my ears. I felt it was in both ears. I was prescribed Flonase and to keep my nasal passages clear.
4/29 66y.o. male with past medical history most significant for CAD, CHF on ASA and plavix presents  with chief complaint of enteritis, hypoxia. Patient a transfer hospital due to upper GI bleed, enteritis, shortness of breath.
Rash to face & arms 8/23/10 no rash today 8/24/10. See OV note.
Received shot on 6/25, called office on 6/28 stating redness and swelling at tetanus site, has been getting bigger. No problems breathing OV 6/28 some induration 10 x 9 cm warmth, redness, swelling given abx 6/28 ?cellulitis.
Soreness at injection site. Stiff arm. Can't lay on it. Can't raise it. Gets numb, and arm and hands tingle. Can't use arm. Can't go to work.
Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The patient was vaccinated with VARIVAX (Merck) (dose, route and lot number not provided) (dose 1 on an unspecified, dose 2 in February 2008, dose 3 on 24-FEB=2016). Concomitant therapies were not provided. No adverse effect was reported. There was no product quality (PQC) involved. Additional information has been requested.
Ten minutes after receiving my 1st dose I passed out and hit my head on the floor! Causing multiple bruises on my face and head! I was unconscious for 30 seconds, and while unconscious my eyes started to role to the back of my head. When I became alert I was on the floor and I couldn?t breathe! While on the floor gasping for air I vomited twice! 911 was called and an EKG was done on site! It showed that my heart rate was low, and I was transported to hospital ER department. Multiple test were done on me and everything came back perfect! No high blood pressure, not a diabetic, and no Permanent head damage.
pt recvd vax; according to mom pt had t of 108 & screaming for 2 days