chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008839: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack  1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol  1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F  01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body.  1230 Took Tylenol  1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol  with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
Patient stated to me on 11/24/ 18 that  the adverse events she experienced on 11/23/18 were as follows: boneaches, headache, stomachache/ nauseous dizziness, backache. She said she didn't sleep well the night she received the immunization because her entire body ached. She has not received any treatment. She explained  that the headache and nauseous feeling had eased up by her lunchtime, but not the backache. As a pharmacist, I had a consultation with her about the patient information sheet on SHINGRIX which addresses the possibility of the adverse reactions she has experienced and it further states that these reactions normally resolve on their own within 2 to 3 days. If they haven't resolved within such time period, she would need to seek medical advice.
Started on Friday night temperature of 101.0 , nauseated swelling in both knees, sore throat, muscle aches, headaches, diarrhea, shortness of breath hear rate of 129, chest pain, felt extremely sick on Saturday and Sunday lasting till Tuesday Morning .
This case was reported by a consumer and described the occurrence of fever in a 10-month-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline. A physician or other health care professional has not verified report. Previous and/or concurrent vaccination included FLUZONE, non-GSK; SANOFI; unknown given on 16 October 2008. On 16 October 2008 at 12:00, the subject received 1st dose of HAVRIX vaccine (unknown, left thigh). On 16 October 2008, less than one day after vaccination with HAVRIX, the subject experienced drug use for unapproved indication and wrong vaccine administered. On 31 October 2008, fifteen days after vaccination with HAVRIX, the subject experienced fever. The mother of a 10-month old subject reported that her physician intended to give a Hepatitis B vaccine but gave the subject a dose of HAVRIX instead. The subject was 10-months old at the time of immunization, which is below the recommended 1-year indication. The mother reported that two weeks later, the subject had a fever of 103 degrees which resolved. At the time of reporting the outcome of the events were resolved. Follow-up information was received on 24 November 2008, via physician who reported that HAVRIX 720 was given instead of Hepatitis B vaccine to a 10-month-old baby on16 October 2008. The physician advised the parent and the parent mentioned that the subject had a fever for 2 days about a week after the HAVRIX dose. The subject has not been seen in the office.
ER visit with positive COVID antigen test.  Back home but back to hospital by EMS for respiratory distress.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (1 ml, unknown) and experienced decreased therapeutic response. The pharmacist reported that four subjects in a row were non-reactive with a count less than 2.89. At the time of the report no additional information was provided. This is the third of four cases reported by the pharmacist, please see cases A0975396A, A0975397A and A0975399A. Follow-up information was received on 23 May 2012 via healthcare professional who reported on 13 March 2012, 4 October 2011 and 19 August 2011 in a 60-year old female subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (1 ml, unknown, right deltoid) respectively. On 24 April 2012, 42 days after vaccination with 3rd dose of ENGERIX B, 7 months after vaccination with 2nd dose of ENGERIX B, 8 months after vaccination with 1st dose of ENGERIX B, the subject experienced not responding to therapy. On 24 April 2102 Hepatitis B titer result was 2.89. The subject received a booster dose of ENGERIX B on 07 May 2012.
really sick; fever; crying; screaming; This is a spontaneous report from a contactable consumer (reporting for her mother). A female patient of an unspecified age received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 06Apr2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On Apr2021, patient had fever, was crying and screaming. On 07Apr2021, patient was really sick. Reporter stated that everything was wrong with the patient and wanted to know what to do. The outcome of all the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Woke up the next morning with body aches, 101 fever, chills, migraine. As the day worn on fever climbed to 103., nauseous and vomiting. Slight headache and diahhrea on 3rd day following vaccine
w/in 1 1/2hr began itching inc temp 101.6, swelling in area of inj;came back into hlth dept 3Pm gave DPH;had red rash on chest & back;T98.1;raised blister type rash;
They first  gave the tdap shot in the forearm instead of the deltoid. They thought they were giving a TB instead of a tdap. In addition they gave him the tdap in the deltoid.
Pt recvd 1st dose of Hep B vax in SEP91 & 2 wks p/vax devel polyarthritis which persisted for 3 days; pt later recovered;
Information has been received from a nurse practitioner (also reported as a "physician"), via a company representative, referring to a 19 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 dose (anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On an unknown date in November 2017, the patient developed "a quarter sized red, hard, and warm area" at injection site (injection site unspecified). The outcome of a quarter sized red, hard, and warm area" at injection site was unknown. The causality between the vaccination with GARDASIL 9 and all the events was unknown.
Pt was approached by RN and asked if she felt fine. Pt stated she felt lightheaded, refused vital signs, water, and snack. Vaccination was given at 1606, patient noted to have seizure like activity at 1613, STAT RN called by nurse and 911 called immediately , patient's airway was protected, patient's placed on 6L of oxygen via nasal cannula, vital signs were taken. IV was attempted by nurse, unable to succeed due to poor vasculature. Paramedics arrived at 1626, daughter was present at clinic, daughter was informed and husband was called and updated with patient's current medical status. Husband stated patient has a history of seizures. Pt was still seizing en route to hospital with paramedics.
Patient was swabbed for COVID related to her husband spiking fevers. She came to hospital complaining of mid abdominal cramping and nausea without episodes of vomiting
Patient reported back approximately 20 minutes after vaccination with itching on forehead/arms and whelps on neck. Patient was given diphenhydramine 50mg orally, EMS was contacted. Patient began to have heaviness in chest, therefore EMS transported her to hospital for observation and treatment.
10 minutes after receiving YF vaccine, patient developed sharp chest pain which then proceeded to shortness of breath to the point where he could not speak. Patient was taken back to the clinic where a rapid response team was contacted. Member received Epi and Benadryl prior to transport to a civilian emergency room for further evaluation and treatment. Pt received solumedrol and Pepcid IV. He was observed for 3 hours and then discharged with home prescription for prednisone, Pepcid, and epi pen.
Information has been received from a physician concerning a female between 11 and 18 years old (exact age unspecified) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. Subsequently, on an unspecified date, the patient felt dizzy and fainted. It was noted that the patient received at least one other vaccine on the same date as when Gardasil was administered. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. The patient recovered on the same day as when the injection was given. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
fever, chills, headache, night sweats, sore arm, fatigue lasted 24 hours- night sweats and slight fever and headache returned the next night and the third day I was still slightly fatigued
A few days after receiving the 2nd vaccination, my left breast was very painful and enlarged a whole cup size. It stayed that way for a week, then went back to normal very quickly.
Patient called 05/03 (6 days after vaccination) stating he woke up with arm twitching down his right arm, head spinning, heart racing, and head feels foggy and cant see straight. Asked if it could be due to vaccine. Patient was instructed to go to emergency room for assessment and observation.
Patient reports that 1 day following flu vaccine that he felt faint while lying  down and thinks that he passed out briefly.  He also reports feeling achy and nauseous.
Medication error:  no adverse event.   RSV hasn't been approved by ACIP yet.  No adverse event.   Patient pregnant  wk 33.
The patient was administered the pfizer booster one month early. The patient received the second pfizer 9/27/21 and received the booster 1/14/22.  Patient called 1/18/2022 at 10:17 AM no signs and symptoms reported at this time. Patient was advised to  call clinic and seek medical attention if adverse reaction occurs.
Rash on anterior thighs (right > left) that appeared consistent with shingles outbreak
Patient returned to the office about an hour after injection with full body rash, itching, nausea, and flushing.
She had severe vomiting and diarrhea for a couple of hours in the middle of night. I had her in the bathroom with me. I tried changing her clothes to give her a shower. She passed out and fell on the marble floor of the restroom. She fell and broke her nose and chipped her front tooth. My husband and I rushed her to the hospital. They couldn't get an IV in her arm because she was so faint and dehydrated. She threw up some more at the hospital. They did a CT scan there and said she suffered from a concussion from the fall. She stayed in the hospital from 2am to 8am and was discharged, was not admitted. The same day after being rehydrated, we visited her pediatrician who gave her anti-nausea Zofran to help soothe her stomach and was sent home to rest.
physician ordered covid vaccine medical assistant wasn't aware patient had never received primary dose so the booster vaccine was given and not the first dose patient is aware and understanding clinic manager was notified and she contacted pharmacist which stated this could be used as her primary  dose
Swelling of hands with rashes  on wrists looks like an allergic reaction. Hands become tender and itchy along the wrists and palms mostly on the left hand.  Sometimes I start to get bumps on my wrists along with an itchy feeling. Has started happening only at nights close to 10:00 pm. It slowly starts to get worst then it goes away on its own after an hour when I lay down or after taking Benadryl.
Itching; Nausea; Headache; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the left arm on 27Sep2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), famotidine (MANUFACTURER UNKNOWN) and riboflavin (VITAMIN B2); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Sep2021, the patient experienced itching, nausea and headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itching, nausea and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
I experienced itching around my lip, broke out with hives, my lips became swollen with pain I could barely talk.
Received VARIVAX # 2 on 08/31/09, injection area has become red, swollen, painful, area of erythema, well circumscribed, slightly warm, mild pain & touch.  No streaking, no signs of infection.
It was like his whole mouth was decayed.; cheek bones hurt; his face got all pulled together and was tingling; his face got all pulled together and was tingling; teeth aching; problems with his teeth or gums.; problems with gums.; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ENG201, Expiry date: not reported), via an unspecified route of administration on 20Feb2021 08:30 (at age of 70-years-old) as dose 1, single for covid-19 immunisation/ to prevent getting COVID virus being aged 70. The patient medical history was not reported. Concomitant medication(s) included metoprolol (METOPROLOL); lisinopril (LISINOPRIL); fluoxetine (FLUOXETINE). Three hours after the vaccine was fine, but his face got all pulled together and was tingling. Since then had been experiencing teeth aches and problems with his teeth or gums. On 20Feb2021, the patient experienced his face got all pulled together and was tingling, teeth aching, problems with his teeth or gums, problems with gum. Last night (on an unspecified date) was so bad, he didn't knew what to do. It was like his whole mouth was decayed. On 23Feb2021 in the morning, his mouth was ok, but his cheek bones hurt. If he presses on some of his rear teeth near his gums and jaw line, he can still feel it. Stated the cheek bones that went down into the jaw bone which hurt. He was getting ready to call his doctor or dentist to make sure it was not a cavity. Did not knew if this was a side effect or how long it will last. Did not knew what he should do. Description of complaint: Patient experienced teeth aches and facial tingling after COVID-19 Vaccine. Doesn't know if it could be a reaction with COVID-19 Vaccine and his Metoprolol, Fluoxetine, and Lisinopril. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
ACHINESS ALL OVER THE BODY LIKE FLU; RUNNY NOSE; NECK PAIN; BACK PAIN; HEADACHE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced achiness all over the body like flu. On 29-JUN-2021, the subject experienced runny nose. On 29-JUN-2021, the subject experienced neck pain. On 29-JUN-2021, the subject experienced back pain. On 29-JUN-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from achiness all over the body like flu, runny nose, neck pain, and back pain. This report was non-serious.
Child began with a low grade temp of 99.9 degrees F on 3/12/19. Right arm began with swelling and redness on 03/12/2019. Was diagnosed with Cellulitis to right arm.
pt says she developed body aches and pains, dizziness, extreme fatigue, chills.  She was lightheaded and the fatigue was so bad that she felt like she had been drugged.  Her right arm and hand were swollen and painful.  There was a large knot around the injection site.  The pain and swelling in right arm affected her mobility to work.  Large varicose veins appeared on her forehead.  These symptoms lasted about 4 days.  She is better but says she still get large veins that appear on her forehead from time to time.
COULD NOT WALK; LEGS HURT SO BAD FOR 3 DAYS; This spontaneous report received from social media a patient via a company representative concerned a male of unspecified age, race and ethnic origin.  The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal arteriovenous malformation (AVM). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced legs hurt so bad for 3 days, and could not walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from legs hurt so bad for 3 days, and the outcome of could not walk was not reported. This report was non-serious. This case, involving the same patient is linked to 20220222825 and 20220222831.
Large red and warm rash at injection site., eight days later.  A little itchy, too.
This spontaneous report was received from a medical assistant refers to a 4 month old female patient. On 06-AUG-2018 the patient was vaccinated with improperly stored ROTATEQ dose 1, oral for prophylaxis (product storage error).  Other suspect therapies included PREVNAR 13 and PENTACEL. No adverse event reported.; Sender's Comments: US-009507513-1808USA007069: US-009507513-1808USA003706:
10 year old daughter received Flublok Quadrivalent vaccine, no adverse event; Upon second medical examination of the case during internal review, a significant correction was performed on 20-Nov-2019 to correct classification from non-case to valid case.  Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 10 years old female patient who was vaccinated with a dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via unknown route in the right deltoid on 21-Oct-2019.  The patient's medical history not reported and no other vaccines received.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse symptoms reported at the time of reporting.  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.  Information on the batch number was requested.
PT reported-had a ZOSTAVAX vaccine; She said she had a reaction the day after her vaccines; itching on the upper part of her face (over eyes and cheekbones) and her face is a little pink, puffy, and tender, but does not have a rash. No other information given. Exact product start date is unknown. Initial delivery date provided for approximation purposes.
Red, swollen entire lt tricep extending up to shoulder and down arm below elbow. Some chaffing around site of injection. Tx w/ aspirin and ice. The next day it got worse w/ some blood clots around the injection site;seen in hosp for tx.