chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (dose and route were not reported) lot # L016427 and expiry date: 13-APR-2017. The vaccine was exposed to a temperature of 15 degrees centigrade for 12 hours. There were no previous temperature excursions. A data logger was involved. Stability questions were also asked during the call about VAQTA and PEDVAXHIB, however no doses of improperly stored VAQTA and PEDVAXHIB were administered to patients. No product quality complaint was involved. Additional information has been requested.
Spreading rash on arm Vomiting Diarrhea Lasted several hours and left me exhausted for a couple days
Med Error Occurred. When the nurse drew up the diluent she drew up .18ml of diluent vs 1.8ml then drew up the 0.3ml and gave to patient.
blood pressure  been low; Oxygen up and down; She sets down and falls off to sleep; I am having my heart situation looked into as well as my wife; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (blood pressure  been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (blood pressure  been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife). At the time of the report, BLOOD PRESSURE DECREASED (blood pressure  been low), OXYGEN SATURATION ABNORMAL (Oxygen up and down), SOMNOLENCE (She sets down and falls off to sleep) and CARDIAC DISCOMFORT (I am having my heart situation looked into as well as my wife) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.  Reporter reported that the patient had not much problem with the first shot.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received on 22-Sep-2021 contains new event (Cardiac discomfort) was updated. Reporter email and contact details were updated and patient gender updated as per narrative.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 26th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 27th September 2018, 63 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced rash and burning sensation. The patient was treated with valacyclovir hydrochloride. On an unknown date, the outcome of the shingles, rash and burning sensation were recovered/resolved. It was unknown if the reporter considered the shingles, rash and burning sensation to be related to SHINGRIX. Additional details were received as follows: There were no concomitant vaccinations given with the SHINGRIX vaccine. The patient was diagnosed with shingles. She also experienced rash on her back with burning sensation. The patient was diagnosed early and great with valacyclovir. The patient did not require further treatment. The reporter gave consent to follow up from GlaxoSmithKline.
2 doses prior to the age of 6; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (BOOSTRIX).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 07-June-2022 Reporter's comment: The patient received two doses of Tdap - Boostrix (the patient received these doses outside of the country). Patient received both the doses of Boostrix at unknown ages, prior to the age of 6. These doses were administered at a different office. The reporter requested for guidance on how to move forward with immunizations. The reporter was unsure if the patient should receive a third Dtap, as it was required for school entry. The reporter requested data available on if the patient can/should get a third Dtap, if the previous two administrations were Tdap. The reporter consented to follow-up. Additional Supportive Information: As per official schedule 2nd dose of Boostrix should be taken after a gap of 10 years, however the patient received dose earlier than the recommended schedule, which led to drug dose administration interval too short. As patient received suspect vaccine outside this united states country, however the case was processed with the reporters country and follow up requested for more information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022090596:same reporter
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 29-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 29-Dec-2022, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.     Reporter did not allow further contact
Headache, Chills,Joint pain, Body aches, Lethargy Narrative:
I woke up on 2-2-21 and had a large red itch rash on left arm with I received the vaccine.
This spontaneous report was received from a nurse refers to a 5 months old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medication were not reported. On 13-APR-2018, the patient was vaccinated with a dose of unidentified HPV vaccine (name and lot number not provided) for prophylaxis. No adverse effect was reported.
Left arm pain, left breast pain, left chest wall pain. Also left scapula/rhomboid pain. Began about 24 hr after Tdap injection. Initially had low-grade fevers as well as significant pain- moderate relief with TYENOL. Also had weakness/ decreased range of motion.
On 04/29/04, pt started itching around 09:15am.  Babysitter/aunt noticed rash on left arm around 9:30am.  Pt brought to us around 14:00pm.  Treatment: Ice and Benadryl as needed.
Muscle aches; Body aches for 2 days; Constant headache since March 22; Fever off/on since March 22; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 22Mar2021 at 13:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included knee arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), meloxicam (MOBIC) and cetirizine hydrochloride (ZYRTEC) all taken from unknown date for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 01Mar2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 16:00, the patient experienced constant headache since March 22, if she clasped his hands behind head that the region, it hurt to lay head on pillow at times, plus fever off/on since March 22. On March 23, she ran 101 fever (units unspecified), muscle aches, headaches and body aches for 2 days. On 20Apr2021, at the day of reporting 99.8 temp (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcomes of the events constant headache, fever off/on, muscle aches, headaches, body aches were recovered with sequelae in an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
CAME IN FOR ZOSTAVAX VACCINE.  ACCIDENTALLY GAVE VARICELLA.  CLEINTS STILL AT CLINIC AND I NOTIFIED THEM OF THE ERROR.  WENT AHEAD AND GAVE ZOSTAVAC IN OTHER ARM.  REALIZED WITH INJECTION I SHOULD HAVE WAITED FOR ZOSTAVAX VACCINE.  CDC HOTLINE CALLED.  NO LIFE THREATENING REACTIONS SHOULD OCCUR.
It was reported that a 61 year old female pt received 0.5cc of Fluzone (U0926BA) administered in her left arm IM at 9:10 am on 11/13/02. Fifteen minutes later the pt complained of numbness and tingling of lips and she stated her "tongue felt thick." Her vital signs were stable. Benadryl 25mg was given per oral and she was monitored for 30-40 minutes. Pt stated she was "feeling better" and denies any SOB or wheezing. The pt was given a Benadryl 25mg tablet to take with her in case of reocurrence and instructed to call back. The pt reportedly recovered from this experience and returned to work. This case is closed.
pt recv vax & devel edema of the injected arm;pt was seen in ER & sent home;5 days post vax pt seen by MD dx cellulitis & hosp pt;
Rectal bleeding 2 days after receiving 2nd shot in arm on 1 April 2021. . Rectal bleeding only occurred after bowel movements that were loose. Experienced some diarrhea 2-3 days and rectal bleeding continued until 9 April before slacking up.  Blood in stools, watery and dark red.  Upon tissue wiping, observed stringy, dark red blood, clot like discharge. Some stomach cramping 2-3 days after 1 April.   Felt some   slight fatigue and sleepy.
Day of vaccination 9/26: Progressive chills throughout the day, subsequent diffuse muscle aches, mild headache, congestion, weakness, finger tingling, fever >102 for several hours with shaking chills. Alternated Advil and Tylenol from approximately 18:00 until 02:00. Fever ~100 at 02:00. Low grade fever over 100 the next day 9/27, treated with Advil and Tylenol. Muscle aches improved. Temp and symptoms resolved on 9/28 upon waking.
Information has been received on 06-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 22-JUL-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-DEC-2016, the patient was treated by a physician in a physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. On or about 04-FEB-2017, the patient received subsequent treatment at a physician's office for ongoing and worsening symptoms of shingles accompanied by post-herpetic neuralgia, a chronic condition of nerve damage secondary to zoster infections. On or about 17-FEB-2017 and 23-MAY-2017, the patient was subsequently treated at a physician's office for ongoing and uncontrolled symptoms related to her zoster breakouts. The patient has been prescribed LYRICA, VALTREX, gabapentin, hydrocodone, NORCO and LIPODERM patches for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I had congestion and a sore throat and some coughing, but not extraordinary. I took a COVID-19 test and it was positive. I talked to a doctor on Telehealth and got prescribed Paxlovid. I also took Mucinex for the cough and Nyquil. I was also fatigue for the additional ten days. Paxlovid left the worse taste in my mouth and my symptoms were mostly gone within the five days of the prescription. I also ran a low-grade fever. I took Tylenol to take the fever down. I did not lose taste or smell. I don't have any continuing side effects.
Swollen vein; Numbness; High blood pressure; Shaking; Area became numb; Area became bluish purple; A spontaneous report was received from a 72-year-old of female patient who developed swollen vein/ Vein disorder, numbness/ Hypoesthesia, high blood pressure/ Hypertension, shaking/ Tremor, Area became numb/ Hypoesthesia and area became bluish purple/ Skin discolouration   The patient's medical history included asthma, COPD, and osteoarthritis and the prior allergies of penicillin and antibiotics. Concomitant medication included thyroxine, benzonatate and Flovent.  On 07 Jan 2021 at 11:15 am, the patient received first dose of mRNA-1273 (Lot number: unknown) via unknown route left shoulder intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Jan 2021, after receiving the first dose of mRNA-1273, the patients vein on left hand became so full, area between thumb and index finger became numb bluish purple within seconds. It was thick and full of blood, it become normal. Blood pressure was a little high because she was shaking. Veins became so bloated. Vein was visibly blue and swollen from hand to about the elbow.  Treatment for the event included Ice pack and Tylenol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events like swollen vein/ Vein disorder, numbness/ Hypoesthesia, high blood pressure/ Hypertension, shaking/ Tremor, Area became numb/ Hypoesthesia and area became bluish purple/ Skin discolouration were not reported.; Reporter's Comments: This case concerns a 72-year-old female who experienced NS unexpected events of vein blue and swollen (vein disorder), hypoaesthesia, skin discoloration, hypertension and tremor.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment included Tylenol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever, headache, nausea, fatigue, shivering.   Adverse effects: Throat and ears soar. Aligns timeline wise with the other reactions and is lasting longer. I haven?t been sick in a long long time so I believe it?s from the vaccine.
6/5/09 - Mom brought child in, Dr saw a red, hot to touch area to (L) deltoid, measured 5in by 5in in diameter.
Mother states that when dressing child this am, she noted redness to thighs bilaterally. Assessed in clinic @ 3:15 with fever (102.6 Tympanic) and fussiness.  Ibuprofen adm. with good results. Improvement of all symptoms on 12/15/16 per Mother.
Injection site swollen, red and itchy; area about 2" diameter; treated with ice packs and dermal antihistamine cream. By 11 PM day of injection, joints in extremities achy. During night, experienced fever, chills, shakes, shivers and aching muscles. Treated with Tylenol. Next day awoke with severe headache and nausea. Didn't eat much due to nausea but did not vomit. Treated headache with Fioricet which I have for PRN use with migraines. It didn't help. Slept during afternoon but not as tired as from first dose of Shingrix. Headache gone after about 36 hours. Site reaction resolved by Thursday, August 8, 2019.
Developed red lump on outer left thigh 2/11/21. Mom reports warmth and pain to palpation. On exam, there is a dime-sized firm lesion on outer upper left thigh slightly warm to touch. Patient cries with palpation. No bleeding or drainage. No evidence of abscess. Patient is treated for possible cellulitis with Keflex times 7 days. Advised to apply warm compress 3-4 times daily. Plan to f/u in 3-5 days for recheck.
inflammed, blisters, hives lasting from 8/19/19-8/22/19
Swollen lymph nodes; Painful underarm; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via Other company (Mylan).  This case involves a 56 years old female patient who experienced swollen lymph nodes (lymphadenopathy) and painful underarm (axillary pain), while she received vaccine YELLOW FEVER VACCINE - FR [STAMARIL].  The patient medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE - FR lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious swollen lymph nodes (lymphadenopathy) and painful underarm (axillary pain) (Unknown latency) following the administration of YELLOW FEVER VACCINE - FR.  Other relevant tests were not reported.  Final diagnosis was painful underarm and swollen lymph nodes underarm.  It was not reported if the patient received a corrective treatment.  The outcome was not reported for both the events.  There will be no information available on the batch number for this case.
Within minutes of injections of both shots felt odd in the head followed by peripheral numbness left side of head which progressed to the left lip area.  The following days had headaches, the need to nap or nod off frequently, occasional chills and just not felling normal.
pt recv vax & w/in 24hr post vax pt exp h/a, fine cyclic extension tremors of both hands;h/a resolved w/in a few days post vax but the tremors cont;
bilateral arm, and neck numbness 15 min after  vaccination. next day numbness in arms persisted and included face .  headache also present.
pt w/large 4in diameter area of redness on rt thigh w/warmth & firmness in center @ inj site;no fever;mild tenderness;
Experiencing aches and pain all over his body; Aches and pain within joints; Diarrhea; No appetite; Weakness / has had no energy / still weak; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included secukinumab (Cosentyx) for product used for unknown indication.   On 11th May 2021, the patient received Shingrix. On 13th May 2021, the patient started Cosentyx at an unknown dose and frequency. On 14th May 2021, 3 days after receiving Shingrix, the patient experienced general body pain, joint pain, diarrhea, appetite absent and weakness. The action taken with Cosentyx was unknown. On an unknown date, the outcome of the general body pain, joint pain and diarrhea were recovering/resolving and the outcome of the appetite absent and weakness were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, joint pain, diarrhea, appetite absent and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received the Shingrix vaccine and then received his monthly dose of Cosentyx 2 days later. The patient started experiencing aches and pain all over his body and within joints, diarrhea, weakness, no appetite, and had no energy.  The patient had sent a message out to his health care professional who did not seem concerned and had not called the patient back.  On the reporting date, the patient's symptoms seemed better but was still weak and had no appetite.  The reporter had questioned if it could be from the shingrix vaccines or due to combination of both shots. The reporter consented to follow-up and gave consent to follow-up with health care professional. It was unknown if the reporter considered the general body pain, joint pain, diarrhea, appetite absent and weakness to be related to Cosentyx.
nausea; Migraine; night sweats; achy; clammy; arm pain; weakness; could not sleep well at all; headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received BNT162B2 (BNT162B2, Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (Age at vaccination 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were none. No Known allergies. The patient historical vaccine includes received first dose BNT162B2 (BNT162B2, Batch/Lot number and Expiration date: was not reported), via an unspecified route of administration, administered in Arm Left on 22Jan2021 04:00 (Age at vaccination 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. No Other medications in two weeks and No other vaccine in four weeks. covid prior vaccination and covid tested post vaccination was No. On 12Feb2021 23:00 the patient experienced Migraine, nausea, night sweats, achy, clammy, arm pain, weakness. Woke up every hour, could not sleep well at all. Pounding headache around 7am. Nausea but not to the point of puking. No treatment was received for events. Outcome of the events was recovering.   : No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Inside of same arm started to swell, itch, get hot and red. The day after vaccination.
Was seen earlier that day for ADHD F/U. Mom went to restaurant and when she looked back at child, she noticed he dropped food, his eyes rolled back, his lips turned blue and he broke out into a sweat. He seemed to be that way for 3-5 minutes. Dr. seen him at night clinic and sent child to neurology.
After receiving vaccine - pt fainted, tremors noted of bilateral upper & lower extremities with eyes rolling. No LOC. Recovered immediately.