chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient had no medical history and drug reactions/allergies. On 01-OCT-2013 the patient was vaccinated with PNEUMOVAX 23 lot # 1947AA expiry date-20-OCT-2013, in the right arm. On 01-OCT-2013 the patient experienced injection felt like an electric shock and with in hours site became red, swollen and warm. The injection site became hard and size of a lemon. The patient iced her arm and took ADVIL which did not do anything. The patient stated that pain is worse at night and causes difficulty sleeping. The patient had seen an unspecified neurologist, who prescribed her Gabapentin. The patient had decreased mobility of injection arm and despite pain subsiding activity causes flare-ups. In addition blood pressure is increased, causing an unspecified physician to increase her treatment of Atenolol, amlodipine, Losartan. On 03-APR-2014 the patient had limb and muscle weakness and significant loss of use of her arm (disability). The reporter stated that the patient might have some atrophy. Investigations included CAT scan (unknown date): unknown results and ENG (unknown date): unknown results. The outcome of significant loss of use of her arm, she may have some atrophy, activity causes flare-ups, decreased mobility of injection arm, difficulty sleeping, pain is worse at night, injection site became hard and size of a lemon, site became red, swollen and warm, injection felt like an electric shock, she had limb and muscle weakness and blood pressure is increased is unknown. The causality assessment was not provided. No product quality compliant was involved. Additional information has been requested.
Covid test was positive; Covid test was positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:45 as dose 4 (booster), single (Lot number: Gj5342) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: EW0191), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Sep2022, outcome "not recovered" and all described as "Covid test was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201198063 same patient, different events after different doses of the vaccine;
Decrease in vision of both eyes on the fourth day following vaccination. No improvement yet. Has not experienced anything similar in the past.
I have experienced noticable tightness in left neck area after the first shot with exaserbation one day after the second shot; pain in left neck area; changes in sensation left arm and hand intermittent; inability to perform functional activities at my usual level; Medrol dose pack; I did my own Physical Therapy initially, now in out patient PT and pain clinic
Severe chills, fever, headache, loss of appetite,  extreme fatigued,  night sweats,  Went to UR 3 times and they confirmed bad reaction to vaccine
I was informed by the MA administering the vaccine that she did not dilute the vaccine prior to vaccination.  No known adverse effects at this time.  Patient's mother was notified about error.  She is going to keep an eye on the patient and will present to ER if any symptoms occur and will follow up with doctor.
Information has been received from a physician concerning an 8 year old male who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/26/03, the pt developed chickenpox characterized by about 35 lesions. Unspecified medical attention was sought, but treatment was not required. At the time of this report, the pt was recovering with sequalae (unspecified).  The physician also reported that the pt's two brothers also developed chickenpox after being vaccinated with varicella virus vaccine live (WAES #'s 0311USA00327 & 0311USA02059).  Additional information has been requested.
Information has been received from a state immunization official (also a healthcare worker) referring to 6 or 7 patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # was reported as M025865, expiration date 24-MAY-2018; dose and route were not reported). The vaccine was improperly stored at 17.5 Fahrenheit (F) for 1.5 hours and 14 F for 2 hours. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. Additional information has been requested.
I started getting very sore in my left arm about an hour after the shot.  By 7 PM, I developed a 101 fever, chills, body aches throughout and a very bad headache.  I started taking Tylenol at 9:30 and by 6:30 the next morning, the fever was down to 99 but aches and headache still present.  Went to local clinic thinking could potentially be covid.  Was tested negative for Covid.  Asked doctor there if this could be reaction to flu shot and she said no, only if it was an aerosol.  Continued to take tylenon for next day to deal with aches and headache.  Fever was back to normal by Friday morning.  Friday morning I reached out to my doctor, explained symptoms and they said it was most likely a reaction to the shot.
Information has been received on 18-MAR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 03-JAN-2017, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster.) Shortly after receiving ZOSTAVAX, the patient suffered intense body pain, fatigue and flu like symptoms and developed a rash on his back. Consequently, the patient was diagnosed with herpes zoster, and later diagnosed with post varicella zoster neuropathy, thoracic neuralgia, translumbar polyradiculopathy, peripheral neuropathy and recurrent herpetic infections. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitation not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent and incurable injuries, as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages.  Herpes zoster, post varicella zoster neuropathy, thoracic neuralgia/translumbar polyradiculopathy, peripheral neuropathy and recurrent herpetic infections were considered to be disabling. Upon internal review, peripheral neuropathy was considered to be medically significant. Additional information has been requested.
pt recv vax 13JUL96 & 14JUL96 pt devel hives on forehead, hairline, forearms;hives were described as vesicular & itchy;tx w/DPH;
Pt called about 1.5 hours after receiving the vaccine stating she felt her throat was swelling and she had swelling in her jaw and neck, and they were warm and numb.
pt recv vax & rxn was noted -redden area @ inj site;red & warm to touch 20DEC96;pt recv vax 19DEC96;
DID NOT TAKE HIS SECOND AND THIRD DOSE; This spontaneous case report (PVX2019-2844) was received from a physician on 18-Nov-2019. It described an adult male consumer who "did not take his second and third dose" (PT: Product dose omission), while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 13-Nov-2019 and went away. The physician reported that the consumer missed the second dose of Vivotif, and he wanted that the consumer should continue the remaining doses every other day starting 18-Nov-2019.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A patient forgot to take the second and third dose of Vivotif (missed dose). The causality of the event missed dose is not related to Vivotif.; Sender's Comments: A patient forgot to take the second and third dose of Vivotif (missed dose). The causality of the event missed dose is not related to Vivotif.
Patient was given 0.5 ml injection of Moderna vaccine as a booster to his Johnson and Johnson Covid vaccine instead of the 0.25 ml booster dose. Patient has not had any issues so far, but continues to monitor for symptoms.
Patient spouse called wanting to report husbands symptoms after receiving the HD flu shot the day before. She stated that every year he has gotten the high dose vaccine, he has reacted with minor body aches but this year seemed severe. She stated that he was experiencing "full blown flu symptoms" with aches, fatigue, chills, nausea, stomach pain, etc. She states he previously had COVID -19 and was sure he was reacting from the vaccination and wanted to let us know. I explained to the patient's spouse to keep an eye on his symptoms and if they worsen or do not improve to contact their doctor to be seen.
Information has been received from a registered nurse concerning a patient of unknown demographics. Pertinent medical history or drug reactions/allergies were unknown. On 06-JUL-2015 the patient was inadvertently vaccinated with an expired dose of GARDASIL (intramuscular, expiration date was 02-JUL-2015; dose, lot number were unspecified). No adverse effects were reported. Additional information has been requested.
I administered the incorrect vaccine at 4:40 PM on 04/03/2020. I administered Hepatitis A in the left thigh. The right vaccine that was supposed to be administered was Hepatitis B. The parents of the patient were informed by staff. Parents of the patient agreed to have Hepatitis B administered. Staff then proceeded to administer
Received flu shot 11-5-14. Arm (left) was very sore and a week later experienced severe arm pain and even had trouble lifting arm. As of 11-26-14 arm still hurts to sleep on but can finally lift arm up above head.
INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; VACCINE UNDERDOSE; ACCIDENTAL EXPOSURE TO PRODUCT; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: Unknown) .3 ml, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced inappropriate dose of vaccine administered. On 10-MAY-2021, the subject experienced vaccine underdose. On 10-MAY-2021, the subject experienced accidental exposure to product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate dose of vaccine administered and vaccine underdose was not reported. This report was non-serious.
Headaches for 2 days; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 10:45 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included escitalopram oxalate (LEXAPRO) and galcanezumab (EMGALITY); both for unknown indication since an unknown date. The patient did not received any other vaccines within 4 weeks prior to the  COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 06:00, the patient experienced headaches for two days and fatigue. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache was resolved on 01Apr2021, while that of the event fatigue was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
2 hours after vaccination noticed severe nausea, no vomiting, chills, sweats, shakes that evening with headache and red achy eyes - sx resolved w/in 12 hours.
Pt. states that after receiving the 1st dose of Shingrix 11/04/2021, started experiencing symptoms 11/05/2021 of hives throughout the torso area, lower back to bottom, and (left) arm. Fatigue, nausea, and loose stool associated.  Primary communications 11/08/2021 (waiting for guidance).
Approx 15min p/vax, erythema noted @ inject site, face flushed; Some areas of patching of erythematous rash noted on lt shoulder & neck; No resp distress noted; Ice pack applied to inject site; DPH recvd;
A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving Nasal FLUMIST started on 23-Aug-2012. The patient experienced tested positive for flu which started on 24-Dec-2012 and ear infection. The patient recovered from the event of ear infection and tested positive for flu on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/MedImmune 26-Feb-2013 from Health Professional: New event of ear infection was added. Event outcome of event tested positive for flu was updated. New reporter added as other. Dose regimen of suspect drug was updated.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and developed shingles. No vaccines data was provided. The reporter consented to follow up.
OBSTRUCTIVE SLEEP APNEA ACUTE STROKE OF MEDULLA OBLONGATA, UNSPECIFIED TYPE AND ARTERY
Rash on face, neck, R arm, legs and back. Red bumps, itchy
Developed cellulitis around injection site within hours of injection which spread down to wrist. Required ER visit and subsequently admission for IV antibiotics. Information from medical records states chills. msv
Patient had rash on the rash on the trunk and chest that appeared 2 days after the immunization.  Patient stated that the injection site blistered, but there were no signs of this at the time. The injection site looked normal at the time of arrival.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 25-NOV-2015 the patient was vaccinated with MMRII (lot # L001336, expiration date 13-JAN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
I received the COVID-19 vaccine yesterday, Monday December 21, at 0700. Last evening I was up all night with fairly severe symptoms, including a severe migraine unrelieved by pain medication, nausea and vomiting, muscle and joint pain, and a low grade fever. I felt unsafe to return to work today and called out due to my fever.
About 2 weeks after receiving the vaccine I had multiple nosebleeds every day x 2 weeks . I did see Dr  on October 20th .
Inflamed throat, phlegm, general malaise, swollen larynx resulting in inability to sing.  Unknown at this time if will be permanent or if tissues will resolve issue and singing voice will return.
patient received two doses of Fluzone High Dose within 10 minutes of each other/ No AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who received a 0.7 ml two doses of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] injection (lot: UJ501AA, expiry date: 30-Jun-2021), via an unknown route and site, on an unknown date for prophylactic vaccination respectively (extra dose administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  It was an actual medication error due to extra dose administered. It was reported that patient received two doses of Fluzone High Dose within 10 minutes of each other in addition to Shingrix injection.  At the time of reporting, patient had no adverse event.  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 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.
10 minutes after vaccine, client c/o difficulty breathing. EMT on site, auscultated wheezing in upper lobes, administered nebulizer treatment. Client discloses recent bronchitis, and history of asthma.
After about 48 hours past my vaccination, I woke up due chills, body aches, cold sweats, high fever at 101.9, and nausea. I took some acetaminophen. Afterwards I was shaking, vomiting, having diarrhea. I was administered a full dose during my booster vaccine. I spoke with my doctor and the symptoms went on for about another 72 hours. Eventually the fever and vomiting subsided and I started to feel a bit better. It took a whole five days to get over these symptoms. I have not had any reoccurrences of symptoms. I am afraid to have my next vaccination as well. In November it was the first time I had ever seen a nephrologist.
This is a spontaneous report from a non-contactable consumer. A 17-year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA, via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient received a shot of TRUMENBA and complained of a very sore arm on an unspecified date. She took ibuprofen to ease the pain. The patient was still complaining of a sore arm and she has continued to take ibuprofen to manage the pain. Follow-up (17-AUG-2016) Follow-up attempts are completed. No further information is expected.
Since receiving 2nd dose of vaccine have had abdominal cramping and diarrhea daily; Since receiving 2nd dose of vaccine have had abdominal cramping and diarrhea daily; This is a spontaneous report from a contactable nurse, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Jan2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included HTN (hypertension), anxiety, GERD (gastroesophageal reflux disease), COVID-19 on an unknown date in Mar2020 along with pain stomach and diarrhea. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date in Mar2020. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included omeprazole (PRILOSEC), valsartan (MANUFACTURER UNKNOWN), venlafaxine hydrochloride (EFFEXOR) and melatonin (MANUFACTURER UNKNOWN); all for unspecified indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an 23Dec2020 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On an unknown date, the patient underwent 6-week V-safe check in and did mention possible complication. On 14Jan2021 after second dose, the patient experienced abdominal cramping and diarrhea daily. The events did not result in doctor or other healthcare professional office/clinic visit, 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 abdominal cramping and diarrhea were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick/ ill for 7 weeks), DYSPEPSIA (sour stomach), DECREASED APPETITE (no appetite), FATIGUE (extreme fatigue) and PYREXIA (temperature that bounced all over the place) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-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 ILLNESS (Got sick/ ill for 7 weeks), DYSPEPSIA (sour stomach), DECREASED APPETITE (no appetite), FATIGUE (extreme fatigue) and PYREXIA (temperature that bounced all over the place). At the time of the report, ILLNESS (Got sick/ ill for 7 weeks), DYSPEPSIA (sour stomach), DECREASED APPETITE (no appetite), FATIGUE (extreme fatigue) and PYREXIA (temperature that bounced all over the place) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.