chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of infantile spasms in an infant male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated polio vaccine combined for prophylaxis. On an unspecified date on or before May 2005, the subject received a dose of Pediatric (dose number and lot number not provided). At an unspecified date on or before 5/05, less than one year after vaccination with Pediarix, the subject experienced infantile spasms. The outcome of the event was not reported. Comment: Infantile spasm was assessed as medically serious (OMIC).
Pt developed a high fever of 104F and was given Advil but fever lasted 6 hours.
Pt presented two days after vaccine administration  to clinic concerned about tenderness, weakness, pain on back of neck, swelling, and redness on site of injections.
Information has been received from a pharmacist concerning a 69 year old female with no known allergies who on 18-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot no. 659406/0298X) via subcutaneous route. Site of injection was not reported. There was no concomitant medication. On 19-JUN-2008 the patient developed swelling and tingling of her upper lip. The patient took OTC BENADRYL for her symptoms. At the time of report, the patient was recovering from the symptoms. The patient sought unspecified medial attention. Additional information has been requested.
This case was reported by a nurse to a sales rep and described the occurrence of injection site hives in a 19 year old male subject who was vaccinated with hep A vaccine (Havrix) for prophylaxis. The subject had no known allergies. On an unspecified date on or after 23Dec04 and on or before 03May05, the subject received the second dose of Havrix. The site of the injection of Havrix was not provided. At an unspecified time following the second dose of Havrix, on an unspecified date on or after 23Dec04 and on or before 03May05, the subject experienced a hive-like rash at the injection site. The injection site hives resolved on an unspecified date on or after 23Dec04 and on or before 03May05.
pt. had an unprovoked embolic stroke on 12/22/21. no causative factor found despite extensive workup. Pt. also had influenza vaccine 11/2021.
Urinated a blood clot; Dry cough; Red bloches on my body; Became ill; developed 5 blood clots that ended up in my lungs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient had his second Pfizer shot the middle of Jan2021, in Mar2021 patient urinated a blood clot in the same month he began to have a dry cough and red bloches on his body. As the summer progressed (in 2021) patient became ill to make a long story short he developed 5 blood clots that ended up in his lungs. Patient was a very healthy 70 years old male until he received Covid shot. Patient knew no one wants to admit to the shot creating any problems but he really believed the shot caused him problems. Outcome of events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose). On 14th November 2018, the patient received the 2nd dose of SHINGRIX. On 15th November 2018, 1 days after receiving SHINGRIX, the patient experienced headache, chills and general body pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, chills and general body pain were unknown. It was unknown if the reporter considered the headache, chills and general body pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with the second dose of SHINGRIX one day before the date of reporting. On the date of reporting, the patient woke up with headache, chills and body aches. The patient stated that this did not happen with the first dose. The patient saw these side effects were common. The patient enquired that how long would the events last, the patient was nervous because she had to travel on the next day of reporting and hoped she would feel better. The patient stated that Advil seemed to helped out somewhat.
Patient received vaccination at 7:35pm. 10 minutes later, patient reports burning in throat and a feeling of lumpiness in throat. Patient was given Benadryl 50mg orally as one dose. Symptoms improved within 30 minutes. No other side effects reported or observed.
Patient developed symptoms of diarrhea, nausea, vomiting, headaches on 05/05/2021. Seen in the clinic on 05/12/2021 declined COVID testing. 05/17/2021 reported chills and bodyaches, positive for COVID.
Less than 12 hours after the vaccination I woke up at 1 a.m. with severe chills and body aches, a 102 fever and terrible headache.  The worst of this lasted 5 or 6 hours and slowly improved, although I could not get back to sleep. I was out of commission for the entire day.   At 6 p.m that evening my temperature was still at 100 degrees and the headache remained.  The following day, April 8th, I did feel better. I was still fatigued and only then did I notice any pain/sensitivity at the injection site (I think the body aches masked anything less severe). This pain was to be expected and nothing out of the ordinary. I am fine now. I was taken aback at the severity of the adverse reaction.  Also, my 20-year-old son got the shot at the same place -- with the same Lot Number 043A21A -- and had exactly the same reactions as I did. (They even started one hour after mine -- the same amount of time our injections were spaced out).    (He may not be reporting it.  Being only 20, he's not as thorough with these things although I will try to get him to do so).
REACTIVE ARTHRITIS IN LEFT KNEE AND HIP; This spontaneous report received from a patient via a company representative concerned a 62 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No prior health issues. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. On an unspecified date, the patient experienced sick (dose number in series 1). The outcome of sick was not reported. The patient received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered at left shoulder on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced reactive arthritis in left knee and hip, and dire pain (both events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reactive arthritis in left knee and hip. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220153538.; Sender's Comments: V0: 20220150708-COVID-19 VACCINE AD26.COV2.S- reactive arthritis in left knee and hip. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pfizer vial diluted with 0.9mls of 0.9%  sodium  chloride instead of 1.8mls
At the injection site of the Varicella the patient reported swelling/redness/itching on 9/8/23 (size of a half dollar coin).  At the injection site on 9/9-9/11 the patient developed vesicles (the size remained that of a half dollar coin). The patient continued to complain of itching and burning sensation.  The patient will contact our office if any worsening symptoms, if not our office will follow up in 1 week with her.
Patient's age was not verified prior to receiving injection. Patient is 17 years old--not over 18 as directed with this vaccine.
Was due for his second dose today but woke up with a cold; He is sick; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US support. A 62-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration in left arm on 20May2021 at 11:00 as 1st dose, single dose for COVID-19 immunization. Patient had no medical history. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 10Jun2021, Patient was sick and was due for his second dose today but woke up with a cold. Patient was taking COVID Vaccine because of COVID Prevention and his wife was bugging him to get it. Patient was not asking about timing but asking for assistance with rescheduling his appointment for his second vaccine dose. Patient had no other vaccines on the same day as the suspect product. Patient did not visit emergency room or physician office. The outcome of the events was unknown.
Pt received Prevnar and Covid-19 on 8/10, on 8/11 she started to get swelling up the right side of her face/eye causing puffiness/watering of the eye.  This lasted about 3-4 days.
Patients have been experiencing  body shivers , right arm swollen , pain and  warm  and very weak and no energy.
Patient admitted to hospital for GI issues potentially r/t COVID vs chemotherapy.  No hypoxia during stay.  Positive PCR on admission.  Provider d/c note:  "67-year-old male with past medical history of lung adenocarcinoma on chemotherapy.  Patient was admitted 09/12 for inability to tolerate oral intake due to oral mucosa pain which is related to his chemotherapy.  Patient was started on mouthwash.  He was also found to be COVID-19 positive, but with no CT findings of COVID-19 pneumonia nor any hypoxia.  However, given his immunocompromised status, ID has recommended remdesivir, which he has completed.  Over the course of his hospital stay, his clinical picture has improved and he is tolerating oral intake.  He is stable for discharge home."
Child described "shaky vision" shortly after getting vaccine (not nystagmus) which went away; started again 9/19/17 and happening more frequently for 1-2 minutes. Had normal ophthalmology, ENT and neurology consults at hospital; form submitted at mom's request.
Local reaction to left forearm left deltoid with red warm area approximately 5 cm x 5 cm.
Developed focal deficits temporally associated to receipt of the spv. See attached. Diagnosis: CEREBELLAR ATAXIA/menigoencephalitis. Symptoms: Abnormal head movement, Gait abnormality, slurred speech.  4/15/09-records received-clinic notes 3/31/09 follow-up visit after hospitalization for 'cerebritis'. C/O headache, fever and vomiting on 1/20/09. Deployed overseas. C/O neck pain with forward flexion and slurred speech, gait unbalanced. PE dysdiadochokinesia and dysmetric in BE on FTN. Treated with IVIG and symptoms unchanged after IVIG. 5/12/10 Follow up: still had tremors at time according to DoD documentation not taking more (Pimozide), improved. Being medically discharged from military.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2016, the patient was vaccinated with the first dose in the GARDASIL series with GARDASIL (dose, route of administration, lot # and expiration date were not reported). On 29-JUL-2016, the patient was vaccinated with the second dose in the GARDASIL series, but the reporter was not sure if it was GARDASIL or GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On 18-OCT-216, the patient was vaccinated with the third dose in series with GARDASIL 9 (lot # M018810 with expiration date 28-MAY-2018; dose and route of administration were not reported). The reporter also stated that the dose of GARDASIL 9 was given too early in the series (on an unknown date in 2016). No adverse effects were reported. Additional information has been requested.
shingles; oozing sores; sore; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles, wound secretion and skin ulcer. On an unknown date, the outcome of the shingles, wound secretion and skin ulcer were unknown.   It was unknown if the reporter considered the shingles, wound secretion and skin ulcer to be related to Shingrix.  Additional details were provided as follows:  This case was reported by the patient's friend. The age at vaccination was not reported. The reporter didn't know his exact age but said it was somewhere around 70s. Two to three days after vaccination, the patient got Shingles from the vaccine.  He had sores that were oozing.  The reporter did not consent to follow-up.
Chief Complaint: CHF exacerbation, atrial fibrillation Source of History: Patient   History The patient is a 90 y.o. female with a past medical history notable for  CHF, atrial fibrillation, arthritis, reflux, hypertension. The patient presents for evaluation of Worsening issues of shortness of breath in addition to fluid overload and swelling. Patient was also having rapid heart rate. Patient was recently stopped on her Cardizem as they thought that this was causing worsening swelling. Patient was set up for an outpatient echocardiogram however had not Got that completed yet. Patient notes that since diuresis patient is feeling much better. Patient is unsure about changes of heart medications. Patient did have close follow-up with Cardiology. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.  3/12/21 remains admitted at Hospital - in patient
Patient received undiluted dose of Pfizer vaccine (0.3 mL undiluted dose) IM
Patient came to the ED complaining of abdominal pain which he states began a few hours after receiving the vaccine. Evaluated by GI and will follow up on colitits
History of esophageal cancer and chronic pain who presents with fevers and SOB. Patient treated with Decadron and Remdesevir
About 8 hours after receiving the shot I had a fever of 103.8, aches, chills, nausea, diarrhea, headaches, and body aches lasting for 2 days.  Since then I have been experiences fevers, chills, aches and pains which come on suddenly and last anywhere from 2 to 10 days.  My head gets "fuzzy", I am unable to concentrate, my legs feel "rubbery".  I have loss of appetite, taste, and smell, and my toes on both feet get red and swollen, especially on the soles of my feet on the pads beneath my toes.  I'm tired all the time and have been known to sleep for days at a time.I haven't felt "normal" since I had the second shot.  I had no adverse reactions to the first shot.
About a week after the vaccine, I started having indigestion and my throat started closing up while I was eating and several people had to help me clear my throat, I went and say my specialist and he prescribed omeprazole and I am suppose to be going back to see him. My throat hasn't closed up since but I have excessive belching and pressure in my chest.
Joint pain; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) and MYALGIA (Muscle ache) 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 24-Aug-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 ARTHRALGIA (Joint pain) and MYALGIA (Muscle ache). At the time of the report, ARTHRALGIA (Joint pain) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient was around a relative who might have exposed her to Covid-19 last weekend, she had herself done a home test which was negative.
Beginning around 3 pm on 3/10/2021 I experienced chills.  The chills worsened, accompanied by bodily shaking.  Around 6 pm I experienced body aches.  By 9 pm my temperature was 100.4 and I had a mild headache.  By 10 pm my temperature was 100.6.  At that time I took two 200 mg ibuprofen.   At 4:00 am on 3/11/2021 I began vomiting and felt like I would pass out.  Vomiting continued until approximately 9:00 am on 3/11/2021.  As the day progressed on 3/11/2021 I began to feel somewhat better.  Since 3/12/2021 I have felt sporadic, brief periods of nausea and light-headedness.  This continues at this time, 3/14/2021.
Patient received Gardasil vaccine dose #2 on 10/1/2009, and that evening she complained of chills, nausea, and several episodes of vomiting.  She reports no fever, and her symptoms resolved that night.  She does report feeling fatigued for the next 24 hours after the onset of her symptoms but reports no futher complaints.
Chills, night sweats, colon discomfort all occurred during the next night.  Colon discomfort continues today (3-18-2021).
Bones felt like glass.  Chills. Shaking.  Lasted for 24 hrs.
Symptomatic 9/3/21 and COVID positive 9/4/21 after being fully vaccinated for COVID-19
Left arm swollen and red. Some swelling noted to go into the neck region. Advised to go to Urgent Care, parent agreed.
Moderna COVID-19 Vaccine EUA Extreme soreness in injection site, headache, low fever (100.3) muscle aches, joint pain, especially in the hip area.  Eased with ibuprofen and was gone after about 24 hours.
most of the vaccine leaked down the patient's arm; most of the vaccine leaked down the patient's arm; A spontaneous report was received from a healthcare professional concerning a female patient of unknown age who was administrated Moderna's COVID-19 vaccine incorrectly.   The patient's medical history was not provided. No relevant concomitant medications were not reported.  On 26 Jan 2021 or 28 Jan 2021, prior to the onset of the symptoms, the patient received their (unknown if 1st or 2nd) dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection.  While administrating the vaccine, most of the vaccine leaked down the patient's arm. The reporter reported the patient was very unhappy about the event. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, most of the vaccine leaked down the patient's arm, was considered resolved.; Reporter's Comments: This report refers to a case of underdose and exposure via skin contact for mRNA-1273 (lot # unknown) with no associated AEs reported.
Patient was vaccinated 3/31/21 and was diagnosed 8/11/21 with COVID-19
Expired Havrix Administerd; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 16th February 2023, the patient received the 1st dose of Havrix. On 16th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The reporter reported that he was notified that a patient was administered a dose of Havrix, which had an expiration date of 30th September 2022.  This was the patient's first dose in the series.  At the time of reporting, the patient was not been redosed.  The reporter consented to follow up. Additional Supportive Information: The patient administered an expired Havrix dose, which led to Expired vaccine used.
This spontaneous report as received from a patient's brother refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (lot # and expiration were not reported). On an unknown date (reported as at night after vaccination), the patient experienced sweating. No treatment was given for the adverse event. The patient did not seek medical attention. It was reported that the symptoms had subsided by the morning of the next day and the patient completely recovered. The relatedness between the event and GARDASIL was not reported. Additional information is not expected since the reporter's contact details were not provided.
Patient developed rash and redness on both thighs that went down to her ankles.  Rash and redness started the following day, and was gone by appointment on 2/10/2021
Within 24 hrs. developed erythema and induration around injection site. Expanded to 6 cm x 3.5 cm by 48 hrs. Mild tenderness and warmth. Ibuprofen and ice as needed. Monitor symptoms and call if worse.
Pt developed swelling/ecchymosis at injection site approximately 2 wks after initial injection. No treatment--ecchymosis gradually resolved over next 2 weeks.
no immediate reactions after this 3rd shot, just the normal sore arm....but a few days afterwards I got vertigo for a couple days and then tinnitus began and it hasn't slowed down, I think it is getting worse. It has been 60 days since shot 3 and I can't get the tinnitus to stop :-( It rings ALL the time.
Patient rcvd 1st covid 19 vaccine on 1/26/2021.  Patient had house guests on 1/30/21.  Those house guests tested positive for covid on 2/1/2021.  Patient started getting symptoms on 02/2/2021.  Patient tested postivie on 2/4/2021.  Patient was hospitalized 2/7/2021.  Patient passed away on 2/21/21.
1/8/21 Recieved vaccine.  1/9/21 started feeling dizzy, lightheaded, tired, body aches, right arm lymph nodes are swollen and tender. 1/11/21 flank pain and upper back pain woke her up today.  1/11/21 made appointment to be evaluated by provider.
History of copd not on home O2, insulin dependent T2DM, CKD stage IV, HTN, HLD, and depression. Presented on 11/25/21 from assisted living for weakness found to have covid 19 pneumonia. CT Chest with b/l pneumonia and possible aspiration, cardiomegaly, b/l pleural effusions, hiatal hernia and cholelithiasis. Patient started on dexamethasone and remdesivir. Patient started on abx for concern for bacterial pneumonia and left lower extremity cellulitis.    Patient weaned to room air, completed remdesivir course and dexamethasone d/c'ed after 6 days. Completed 5 days of IV cefepime and doxy switched to bactrim 12/3 for left lower extremity cellulitis. Amoxicillin added 12/5 for strep coverage for LLE cellulitis. Discharged on 12/6/21
developed mild chickenpox 3 weeks after second dose of varivax. Had Chickenpox exposure prior to vaccine, but mom not sure of date.
Rash that covered the upper body 24 hours after vaccine. Rash resolved in 12 hours with the exception arms, especially the antecubital space. Pt has used calamine lotion to help with itching.