chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kidneys - hives bruising difficult urinating; Kidneys - hives bruising difficult urinating; Kidneys - hives bruising difficult urinating, back pain; Kidneys - hives bruising difficult urinating; back pain; Kidneys - hives bruising difficult urinating; This is a spontaneous report from a contactable consumer, the patient.  A 54-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection, Lot ER8736 expiry information not provided) as a single dose in the left arm on 12May2021 at 11:30 (at 54-years-old) for COVID-19 immunization. There was no medical history reported. Concomitant medications included lamotrigine (LAMICTAL); paroxetine hydrochloride (PAXIL), vitamin B NOS, and vaccinium macrocarpon (CRANBERRY). The patient denied receiving any other vaccine within four weeks of this vaccine. The patient denied any diagnosis of COVID prior to receiving the vaccine and the patient was not pregnant at the time of vaccine. The patient denied being tested for COVID-19 since receiving the vaccine. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection, Lot ER8729 expiry information not provided) as a single dose in the left arm on 21Apr2021 at 11:30 (at 54-years-old). The patient reported that on 21May2021 at 08:30 she experienced Kidneys - hives bruising difficult urinating, and back pain; which resulted in a visit to a doctor or other healthcare professional office. Treatment for the events included unspecified medications. The outcome of the events Kidneys - hives bruising difficult urinating, and back pain was unknown.
12 yo received Shingrix; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2021, the patient received the 1st dose of Shingrix. On 14th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The 12 years old patient received dose of Shingrix, which led to inappropriate age at vaccine administration. The patient had not experienced any adverse events.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received BOOSTRIX (batch number 95HB3, expiry date 11th July 2019). Concomitant products included SHINGRIX. On 28th April 2018, the patient received BOOSTRIX (intramuscular) .5 ml. In April 2018, 1 day after receiving BOOSTRIX, the patient experienced injection site pain, injection site erythema and injection site swelling. In May 2018, the patient experienced injection site itching. The patient was treated with ibuprofen and BENADRYL. On an unknown date, the outcome of the injection site pain, injection site itching, injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site pain, injection site itching, injection site erythema and injection site swelling to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The patient concomitantly received SHINGRIX (batch number T5242, expiry date 31st March 2020) on the right arm. The patient received BOOSTRIX on the left arm and approximately 1 day later called to report soreness in the injection arm. The health care professional recommended ibuprofen. A day or 2 later the patient called again to report swelling and redness in the arm, followed by a report of itching. The health care professional recommended BENADRYL. At the time of reporting, the patient went to urgent care and then presented back to the pharmacy. The red, itchy area had spread down the arm, almost to the patient's wrist. The urgent care visit did not result in any prescribed treatment. The health care professional reported that the patient did not experience adverse reaction in the SHINGRIX vaccination arm (right arm).
Prophylactic antibiotic therapy of clindamycin 1 hour prior to procedure; Arm ached; Injection site area was tender to the touch.; Toothache really bad; Stated that her arm is kind of warm Is her left arm; This is a spontaneous report from a contactable other health care professional (patient). A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 10Feb2021 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation. Medical history included bilateral knee replacement (stated that she had bilateral knee replacement previously and always has to take an antibiotic in order to do any pre-procedures), breast cancer female from 1999 to an unknown date (stated that she cannot have the vaccine in her right because she had breast cancer), lumpectomy, radiotherapy (had lumpectomy and radiation therapy prior to the vaccine) from an unknown date and unknown if ongoing. The patient previously took clindamycin for prophylactic antibiotic therapy. Concomitant medication were not reported. Caller got the first Pfizer Covid vaccine yesterday. She is scheduled to see the dentist tomorrow and wanting to know if it would be okay to take her usual course of antibiotics for this dental procedure. On 10Feb2021 she stated that she reported that her arm ached after receiving the vaccine yesterday and the injection site area was tender to the touch. Caller stated that she has an achy sore arm. Stated that she had bilateral knee replacement previously and always has to take an antibiotic in order to do any pre-procedures. Wanted to know if it taking an antibiotic would have anything to do with the Covid vaccine. Stated that she could not find anything in the literature. On Feb2021 stated that she has a toothache really bad and she has to be seen. Stated that her arm is kind of warm Is her left arm. The outcome of the events was reported as unknown.   Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Blotchy rash, few hives occurring after 15 minutes of MENACTRA Admom. Given 37.5 mg BENADRYL P.O.  5 minutes later c/o tight chest - given EPI - all symptoms resolved
Patient reports "small knots" that appear and disappear over body that and are itchy associated with heat and acidic foods.
first dose Pfizer covid vaccine on 22Mar2021, tested positive for COVID on 02Apr2021; This is a spontaneous report from a contactable consumer (patient's daughter).  This consumer reported same event for 2 patients (her father and mother). This is the second of two reports.   A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Mar2021 (batch/lot number and expiration date were not reported) at the age of 61 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received first dose Pfizer COVID vaccine on 22Mar2021, and tested positive for COVID on 02Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19): positive on 02Apr2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021445679 same reporter, same event, same product, different patients
PHN was talking with pt ~ 5 mins post inj. of pneu. and flu. pt stated felt "lightheaded" pt face was flushed eased to chair. Nurse called for assistance from aide. Pt then grabbed lower R back area described pain as "grabbing and releasing" also stated chest felt heavy with slight SOB. BP 120/90 phoned local MD. Pt felt better pain eased, no further c/p or SOB. Pt taken to MD office per pt vehicle per nurse. Rec'd call from RN. EKG-wnl, pt was sent home in good condition. Phoned pt-states she is "doing okay" no further probs or sx-dx per MD-near syncopal episode.
Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L042214, expiration date 14-JUN-2017; lot # M019706, expiration date 24-OCT-2017, dose unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
DEVELOPED EXTREMELY PAINFUL SHINGLES RASH ON LEFT SHOULDER BLADE BY JANUARY 6TH, 2021. LESIONS BEGAN TO SCAB AS OF JANUARY 13TH, 2021, AND WAS CLEARED TO A DARKER PIGMENTED AREA AS OF JANUARY 25TH, 2021. NO TREATMENT WAS SOUGHT. NO RESIDUAL SYMPTOMS OTHER THAN SKIN DISCOLORATION. PHOTO LIBRARY USED TO ESTIMATE TIME COURSE.
Immediately after 1st pfizer dose pt reported tingling in tongue & lips, it resolved within 30 min without intervention.
65 y.o. man was in excellent health until episode on 2/13. At 11:30 PM he drove from his home to do work in a cow barn. His wife joined him to help at about 12:15 AM and she found him to be disoriented and confused. He has no memory of what happened during the preceding 45 minutes. No indication of any fall or injury. He had no preceding medical problems. No medications. Had received his 1st Moderna COVID-19 vaccine at about 5:30 PM on 2/13. His wife took him to a local ER. No focal findings on neuro exam. His confusion gradually improved over the next 24-36 hours but he still can?t remember what happened at the beginning of the episode. Head CT revealed an incidental 6 mm colloid cyst in the 3rd ventricle. Transferred to Hospital for further evaluation and monitoring where seen by Neurosurg and Neurology. Had MRI and EEG. No arrhythmia on ECG or telemetry. Neurology felt the episode was due to transient global amnesia. Discharged on 2/16.
the patient subsequently has negative titers; the patient subsequently has negative titers; the patient subsequently has negative titers; Route of Administration: intramuscularly; This spontaneous report was received from a physician and refers to a currently 16 years old male patient. The patient did not have any pertinent medical history and drug allergies. His concomitant medication included growth hormones (somatropin).   On 10-JUL-2003,  the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the second dose on 31-JUL-2006, intramuscular (incorrect route of product administration) for prophylaxis (strength, dose, lot # and expiry date were not reported) .  Subsequently, the patient were vaccinated on 25-JAN-2019 and 29-MAR-2019 (strength, dose, lot # and expiry date were not reported) due to his parents had international travel planned. Consequently, it was reported that the patient performed a blood test on 18-MAR-2019 and it showed negative titers (measles antibody negative, mumps antibody test negative and rubella antibody negative)  The outcome of had negative titers was not recovered. The causality assessment between negative titers and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.
Severe skin reaction near injection - red area and warmth that persisted for 2 days.  Appeared within 24 hours of injection.  Photos can be provided if needed
Stroke - Hospitalized 4 days.  Physical therapy 3 weeks.  Lasting balance disorder, cognitive mental effects, memory loss, general weakness.
got them on my / eye; got them on my face; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details provided were as follows: This case was reported by the patient. Age at vaccination was not reported. Patient received the Shingles vaccine and experienced shingles on face and eye. The patient stated that now get series of 2.
Went to the bathroom after waking up feeling dehydrated and fatigued. On my way back from the bathroom I fainted and had a severe laceration on my nose. I was on the ground momentarily before getting back up.
This spontaneous report as received from an office manager of a physician's office via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not mentioned by the reporter. On 07-JAN-2016 (also reported as 07-JAN-2017) the patient was vaccinated with VARIVAX (route, dose# and lot# not reported). Other suspect therapy included HAVRIX. Concomitant medication was not specified. On 07-JAN-2016, the patient experienced a staring episode after receiving VARIVAX. The nurses thought that the event was a sign of a seizure coming on and decided not to give the patient the MMR II. No treatment was given to the patient for the adverse event. The outcome of staring was unknown. Causality statement was not provided by the reporter. No further AE information reported. Product quality complaint was not filed. Additional information has been requested.
Mild Rash/ a rash in her lower back and buttocks; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Mild Rash/ a rash in her lower back and buttocks) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced RASH (Mild Rash/ a rash in her lower back and buttocks). On 15-May-2021, RASH (Mild Rash/ a rash in her lower back and buttocks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.   This case was linked to MOD-2021-229622 (Patient Link).
Post vax, both injection sites bled, turned red and became swollen. Pressure was applied until the bleeding stopped. A small dime sized lump palpated at the DTAP site. The mother was instructed to observe the site and if later swelling, take the patient to her physician. She will see the patient's physician tomorrow.
The morning after I received my Covid-19 Booster injection, I became extremely nauseous. I waited it out because I was told that nausea can be one of the side effects. I increasingly became much much worse. I couldn't eat anything, felt like I wanted to vomit constantly (but never did vomit), and had really unbearable stomach cramping.  I could not really sleep too well at all.  Then on Sunday morning, I ate a piece of toast because I was feeling dizzier than what I had expected and knew I should eat something at least. My stomach became increasingly worse throughout the day, and in the late evening, I contacted my PCP's on-call service and requested help for the severe nausea and the doctor prescribed ZOFRAN for me.  I took the dose immediately after picking it up from my pharmacy, but got little relief and I only slept a total of 2 fragmented hours of sleep.  I took the second dose today, (3 days from my booster injection). however my stomach is still cramping pretty bad and I have no appetite and find it hard to even drink water because it seems to exacerbate my symptoms. I fear dehydration, so I am forcing myself to drink water.  It's imperative i drink alot of water due to my Interstitial Cystitis Disease. I'm not feeling well at all.
Chest tightness, shortness of breath, and rapid demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary embolus.  Expired 9/29/08. 2/9/09-COD-pulmonary embolism.
Patient complained on loss of sensation in lower extremities bilaterally.  Symptoms progressed.  Treated with po steroids for spinal stenosis, with no effect.  Hospitalized 02/11/2010.  Lumbar puncture consistent with Guillain-Barre Syndrome.
This spontaneous report as received from a healthcare worker via company representative and to a 3 patients of unknown age, gender not reported. Healthcare worker was reporting on behalf of physician. On an unknown date the 3 patients were given VAQTA from prefilled syringes that met resistance during administration of the medication and not all the contents were able to iject. About 60 to 65% of the medication was inejcted. The plunger was difficult to push on the VAQTA prefilled syringes. No adverse events were reported. Product quality complaints was involved. The outcome of adverse events was not reported. Additional information has been requested.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 22-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    Concomitant products were not provided. Vaccines which underwent a temperature excursion in the freezer were viable, temperature excursion occurred several days ago in the Freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. Patient did not report any adverse reaction. Treatment medication were not reported.
my lymph node was swollen in my neck and have since found after an MRI they are all swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid 19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "my lymph node was swollen in my neck and have since found after an MRI they are all swollen". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow up (15Sep2021): This a follow up spontaneous report from a contactable consumer.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (25Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
High fever; Chills; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, PYREXIA (High fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            This case was linked to MOD-2021-020745 (Patient Link).
Information has been received from a 64 year old female nurse with hypertension and an allergy to valdecoxib (BEXTRA) and a history of cataract operation who on 23-MAR-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included ramipril (ALTACE), loteprednol etabonate (LOTEMAX), sulfacetamide sodium/sulfur (ROSAC) and aspirin. The nurse reported that she was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) instead of zoster vaccine live (Oka/Merck) (ZOSTAVAX). The patient reported that she picked up what she thought was zoster vaccine live (Oka/Merck) (ZOSTAVAX) at the pharmacy, then went to her doctor office for vaccination. Post vaccination she was given the package insert from the box. When the patient arrived home she found out that the insert was for varicella virus vaccine live (Oka/Merck). So she called the pharmacist who told her "there is no difference between varicella virus vaccine live (Oka/Merck) (VARIVAX) and zoster vaccine live (Oka/Merck) (ZOSTAVAX). Patient's outcome was unknown. Additional information has been requested.
Was having normal side effects including headache, fever, muscle aches which started about 6 hours after injections.  Roughly 14-16 hours after the injection (8:30-9am) started getting chest pain and slight shortness of breath.  Called my PCP and they told me to go to the ER as the chest pain is not normal.   At the ER they did an EKG which came back abnormal and I was rushed into a procedure to check my heart including a catheter, ultrasound, and a few more I will provide below.  Outcome after all the test was inflammation which I asked if it could have been in other areas of my body but doctor said it was my chest.  My C-Reactive Protein level was double the normal level.  They put me on 3 medications, Ibuprofen, one for Gout and Prilosec.
pt experiencing redness around injection site which has expanded, and swelling like a golf ball. she is concerned imz was administered too low
PT EXPERIENCED LOCAL RASH AROUND INJECTION AREA AND MOST OF UPPER ARM. REDNESS STILL NOTICABLE AFTER 21 DAYS WHEN PT RETURNED FOR SECOND DOSE