chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a 68 year old female with hypertension, arthritis and a history of genital herpes.  The patient is allergic to DARVON, FORMALDEHYDE, AVELOX, ZITHROMAX, eggs and chicken.  The patient took VALTREX 500mg once daily for 10 years but discontinued in September 2008.  On 16-JAN-2009 the patient was vaccinated with her first dose of ZOSTER vaccine live (Oka/Merck) (lot number 663638/1706X) SQ into her left arm.  Concomitant therapy included DIOVAN, AMBIEN.  On 27-JAN-2009 the patient developed shingles after vaccination.  The patient was experiencing pain, blurred vision, low-grade fever, flushing and fatigue.  The pruritic erythematous blister-like lesions were across her left eye towards her ear and forehead.  The patient had 4 rows of blisters about 4 to 8 blisters per row.  The patient was prescribed VALTREX.  After starting VALTREX the patient developed diarrhea and headaches.  VARICELLA titer was performed with no results reported.  Follow-up information was received from the nurse.  Then nurse reported that the patient developed shingles on her left face and across her left eye.  The patient was sent to ophthalmologist.  The patient was given VALTREX.  The patient complained of burning and pain at site.  The patient was seen by ophthalmologist twice.  There was no illness at time of vaccination.  The patient's outcome was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 03/27/09. Follow-up information was received from the nurse. On 23-FEB-2009 and 23-MAR-2009 the patient had two visits for post herpetic neuralgia. On 23-MAR-2009 the patient had another outbreak on her face (same location). There was no illness at time of vaccination. The patient's outcome was unknown. No further information was available.
While asleep, rolled onto Left side and was awaken with tingling down Left arm. Tingling remained 9/30 and was seen by physician. No treatment recommended.  Neuropathic sensations resolved completely 10/03/09
having harder time walking after vaccination; started walking kind of funny after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (having harder time walking after vaccination) and WALKING DISABILITY (started walking kind of funny after vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease and Walking difficulty.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced GAIT DISTURBANCE (having harder time walking after vaccination) and WALKING DISABILITY (started walking kind of funny after vaccination). At the time of the report, GAIT DISTURBANCE (having harder time walking after vaccination) and WALKING DISABILITY (started walking kind of funny after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
After her first Hepatitis B vaccination (Recombivax, 1cc, IM injection) on 5-3-07, client reports suffering from generalized pruritis (not limitied to the injection site). She reports no hives, rash, or signs of anaphylaxis. This reaction occured approximately 2-3 hours after vaccination and lasted 2-3 days. This report was made to a nurse upon return for her booster. No booster was given based on her past reaction. Client reports no treatment needed but concerned about future vaccinations with this vaccine due to the previous reaction.
ACCORDING TO PATIENT, HE STARTED SEEING SWELLING AT THE SITE OF INJECTION. SITE OF INJECTION STILL SWOLLEN AND PATIENT COMPLAIN OF PAIN OF 10/11/17 WHEN I FIRST GOT TO KNOW OF THE ADVERSE EVENT. PATIENT SAYS HE WENT TO SEE HIS DOCTOR AND WAS GIVEN CREAM TO APPLY AT THE SITE BUT COULD NOT DISCLOSE THE NAME OF THE CREAM.
ACUTE STROKE DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY 11/10/2021 DM 2 W RENAL MANIFESTATION ACUTE STROKE DUE TO THROMBOSIS OF UNSPECIFIED ARTERY 1/24/2022 DM 2 W RENAL MANIFESTATION
The pharmacy just received new vaccine which both the monovalent and bivalent vaccine were in the same box. The pharmacy also has labels premade to stick on the Vaccination Administration Record(VAR)s which are usually made for bivalent vaccine but this time only monovalent labels were present. The patient was the first patient for vaccination in the day and vaccine was taken out of the bag with open vaccine box. All six doses were drawn and put in a vial for the next vaccinations. The monovalent booster was mistakenly used instead of the bivalent booster. Pt does not have any adverse side effects at this time.
Information has been received from five authors of a published literature article concerning a patient who participated in a post marketing study involving pneumococcal vaccine 23 polyvalent. The 24 month old patient with hb-ss disease with crisis was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included penicillin. It was noted that no penicillin was detected in the serum. In 1997 the patient developed a severe pneumococcal infection and subsequently died. The cause of death was pneumococcal infection NOS. It was also reported that two other patient's developed pneumococcal infections. At this time, relationship of the patient's severe pneumococcal infection to pneumococcal vaccine 23 polyvalent was unknown. The patient's severe pneumococcal infection was considered to be immediately life threatening. Additional information has been requested.  Reported on 03/26/2003: "Follow up information received from the Primary Author revealed that the patient died in 1997.  The child had no previous episodes of sepsis or meningitis.  The serotype was unknown.  The child presented to the Emergency Room in septic shock with a hemoglobin of 2.7. massive hepatoslenomegaly, DTC, went into Ventrivular Fibrillation and "expired 4 hours after presenting".  the parents had reported that the child was taking prophylactic penicillin, however no penicillin was detected in the serum and the blood culture result was Streptococcus pneumonia that was sensitive to Oxacillin.  There was no autopsy performed.  Additional information has been requested.  A copy of the published article is attached as further documentation of the patient's experience.
14cm x 9 1/2cm erythemic area with 10 x 6cm  induration. Keflex 250mg po qid ordered. One tsp po qid ordered; tapering dose.
Reappearance of Burning Mouth Syndrome. Previous had in Jan-Sept 2012.
Got 1st vaccine 2 years ago / Will 2ndvaccine now make it effective or do we have to start over?; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient did not received 2nd dose till the time of reporting, which led to incomplete course of vaccination.  The patient wanted to know if the 2nd vaccine would be effective or do we need to start over. This case has been linked with the case US2021AMR113452 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113452:same reporter
On 8/14/01 AM slight redness and swelling at site, normal per mom. At 4:30 PM noticed quarter size swelling, rock hard and warm to touch. On 8/15/01 at 6 AM there was a large area of right thigh swollen with blisters in center. Noted by Dr on exam at 3 PM on 8/15/01. 12 cm redness with central area 2 1/2 of small vesicles and 1 was broken.
My PCP, MD asked me to contact my pharmacist to report the following vaccination reaction so that the pharmacist could notify the manufacturer and also to find out if there are any recommendations related to the second shot in the series. I contacted Pharmacist on 5/30/18 declined to submit a notification to the manufacturer because the symptoms are on the list of side effects & advised me that personally he would not recommend that I get the second vaccination. I am an RN and am aware of the agony shingles can cause but my PCP & I are concerned about the severity of the reaction I had & would like advice: I had my initial SHINGRIX vaccination around 2:00 PM on Sunday 5/27/18. Right after  receiving the injection I felt briefly nauseous & started perspiring but that passed quickly and I was fine other than a sore arm until around midnight. By midnight I had a pounding headache, fever, nausea/vomiting. I was bed bound/sleeping with fever, headache & nausea/vomiting/dry heaves for about 20 hours after which I began to improve. I was lightheaded all day 5/29 but continued to improve. All symptoms were gone by around 11:00 PM on 5/29. I've never had a vaccination reaction to anything in the past aside from a sore arm. Should I receive the 2nd injection in 2-6 months & if so are there any recommendations/precautions.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007d21a) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS, Allergy to antibiotic (amoxicillin) and Sulfonamide allergy (sulfa medication gives her a rash).    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication included two thyroid medication and two hormone medication.  It was reported that every time the patient had a procedure she needed to take a COVID test.  No treatment medication was provided.   This case was linked to MOD-2022-611799 (Patient Link).
I was awakened in the middle of the night smelling coffee. I went downstairs to kitchen to see if coffee programmer was broken but there was no coffee. I went back to sleep and when I woke  around 8 am I had severe vertigo. It lasted for three days but got better each day.  I have never had vertigo before. Given the news about neurological side effects I decided to report.
I started having blood in my stools for 4 weeks. On 01/19/023 I had bad cramps for the next 5 days. I seen my provider and they advised me to take OTC medication and it made it worst. I had to then go to an urgent care I had gas and stools in my stomach. I had x-rays and a ultrasound.  I also have a colonoscopy scheduled on 03/24/2023. The cramping did stop but I am on medication for regular bowl movements.
Vomiting, diarrhea. Symptoms occurred within 3-4 hours post vaccination.
0944 C/O NAUSEA, WARM SENSATION (OVERALL), TACHYCARDIA, LIGHTHEADEDNESS, SL. SHORTNESS OF BREATH.  EMS ON SITE.  VS:  168/71, p:  58; 97%  O2 SAT R.A.; 0954:  BP:  168/71, P:  58,  98% 02 SAT R.A. 1015:  LEFT AND WENT TO HOSPITAL. ALERT, ORIENTED
INJECTION SITE PAIN Narrative:  MILD PAIN LASTED ~ 1 DAY
Has a lump in arm; Sore arm; Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat; Gums are sore; Headache; Threw up; Nausea; Shaking; Sweating; Really cold (thinks had fever); This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), LIMB MASS (Has a lump in arm) and PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), HEADACHE (Headache), VOMITING (Threw up) and NAUSEA (Nausea). On 15-Feb-2021, the patient experienced LIMB MASS (Has a lump in arm), PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat) and GINGIVAL PAIN (Gums are sore). On 14-Feb-2021, TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (Really cold (thinks had fever)), VOMITING (Threw up) and NAUSEA (Nausea) had resolved. On 15-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, LIMB MASS (Has a lump in arm), PAIN IN EXTREMITY (Sore arm), ORAL PAIN (Started with pain in her mouth and tongue, has "fever blisters" in mouth and tongue, can't eat) and GINGIVAL PAIN (Gums are sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included acetaminophen for headache. The patient also received mouth sore relief-liquid- denzocaine 20%, denzalkonium corfain 13%, camahor 3% to relieve pain in her mouth and tongue.
Pfizer-BioNTech COVID-19 Vaccine EUA: 10 minutes after vaccination patient reported flushing, dizziness, lightheadedness, and tingling. Vital signs all within normal ranges. Transported to emergency department where physical exam was normal; neurological exam reported no focal deficits. Patient denied chills, blurred vision, shortness of breath, nausea, pain (including chest pain), rash, and headaches. Patient observed, symptoms resolved, and discharged to home stable.
Onset was approximately 8 hours. Symptoms include fatigue, myalgia, and flushing. 1000mg of Tylenol PO was taken. 12 hours post injection symptoms progressed to nausea, diarrhea and chills. 2 tabs of Pepto PO taken.
pt given vaxs 4pm, that evening began to have inc temp. Mom gave fever meds next 2 days,pt had temp of 103(R) on 2nd day mom took pt to MD, temp @ that time 104(A).MD states pt dehydrated-adm to hosp.Recvd IV fluids, in hosp 2 days
Pt complained of shortness of breath with productive cough.  Pt admitted for respiratory distress.
Patient came to our clinic today because she is concerned with a rash on left left Deltoid appearing one day after she got vaccinated at pharmacy. She has swelling, redness, and pain on the affected site.  She was advised to take Benadryl, avoid scratching area. She can also apply cortisone cream instead of scratching area. She was told to monitor  and report any symptoms that occur.
Significant irritability, back pain, muscle aches, difficult to console - started morning after vaccine administration, required office visit, ER visit, hospitalization. Resolved within 24 hours with IV ketorolac, morphine, hydration. Also redness and induration (3cm) L thigh at site of MMR and Varicella.  9/17/09 ER record received for DOS 9/11/09 with D/C DX: Excessive crying.  R/O encephalitis.  R/O Immunization reaction.  Backache. The mornng after vax pt c/o leg and back pain, difficulty bearing weight, screaming, feeling hot and cold, chills, tiredness and fever.  PE (+) for refusal to walk, spasm of the paraspinal areas of thoracolumbar spine, mild local reaction at MMR and Varicella vax sites. Observed o/n and d/c.
ADVERSE REACTIONS BY THE VACCINE; MOM OR SISTER HAD A BAD REACTION TO THIS  VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  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, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions by the vaccine, and mom or sister had a bad reaction to this vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adverse reactions by the vaccine and mom or sister had a bad reaction to this vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211138887 and 20211139987.
This spontaneous report has been received from a pharmacist via company representative, concerning to a female patient of unknown age and ethnicity. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not provided. On an unspecified date (also reported as "when the patient was 13 years old"), she received the first dose of GARDASIL 9 intramuscularly or GARDASIL intramuscularly (lot# and expiration date were not provided) (it could not be further clarified which precisely was). On an unspecified day in December 2018, the patient received the second dose of GARDASIL 9 intramuscularly (lot# and expiration date were not provided) or GARDASIL intramuscularly (lot# and expiration date were not provided) (it could not be further clarified which precisely was). On an unspecified day in February 2019 , the patient received her third dose of GARDASIL 9. On an unspecified day of February 2019 (reported as last week) the pharmacist found a "small white, flaky material" inside the vial GARDASIL 9, along the wall, underneath the rubber stopper, prior to puncturing the vial, after the vial was agitated by the pharmacist. The dose was not administered. It was reported that the vaccine did not have temperature excursions and it was monitored with data logger. No adverse event was reported. The outcome for the product impurity issue was unknown. The causal relationship between the product impurity and GARDASIL 9 was unknown.
Patient states that her booster dose gave her body aches and a headache.  She also states that she starting have chest pains periodically about 2 weeks before getting her booster but she thinks they have increased in frequency since she got her booster shot and thinks they may be related.
A couple of days after receiving the vaccine, I started experiencing dramatic headaches that became migraines. A couple weeks later at work, my head started spinning nonstop where I was diagnosed with vertigo. I felt the world was spinning around me. It happened for 3-4 weeks after receiving the vaccine. I vomited profusely where my husband had to pick me up from work. I was in the ER for 36 hours where they performed MRI, CAT scans and lab work on me. I had extreme dizziness and fatigue. And my mom became my caretaker when my husband had to return to work.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with VARIVAX, (route: subcutaneous) that was improperly stored (incorrect product storage). No adverse effects reported. The vaccine underwent multiple unspecified excursions due to defrost cycles and the call was because of the data logger. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA009505:
she had severe reaction (itching arm) that lasted 3 weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date 18Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "different allergies" (unspecified if ongoing), notes: she just have "different allergies". The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "she had severe reaction (itching arm) that lasted 3 weeks". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller stated that she had her first booster shot on 18Jan2021 and had her second shot on 08Feb2021, and she received her booster shot by 08Oct2021. Caller mentioned that she will be having her second booster dose this 08Mar, as suggested by her healthcare provider. Caller also stated that she has heard that mixing up vaccines suggest a higher immunity against COVID19. Caller mentioned that for Moderna vaccine, the booster dose in terms of mcg was lessen. Caller also mentioned that she experienced different side effects after getting the shot. During her first dose, caller stated that she had severe reaction (itching arm) that lasted 3 weeks. Caller stated that the second dose was much easier. Caller stated that on her third dose, she had a fever but just had it overnight. Caller mentioned that she had antibody test made by her doctor and she got 500. Caller mentioned that after getting the booster dose, her antibody went 2000 way up. She mentioned that her doctor was under clinical trial for COVID19 vaccine and was the one recommending her to get her 2nd booster dose. Caller verified that she was immunocompromised. Initially provided information from attached CONS-use in immunosuppressed patients. Caller later on clarified that she was not really immunocompromised and she just had different allergies. Caller stated that people from her dermatologist already received their second booster shot. Caller mentioned that she will still get the second booster shot to be on the safe side and will continue to wear n95 masks. Caller also stated that if she will experience any adverse reaction, she will definitely go the emergency room.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
48 yo male received first dose of his Pfizer COVID-19 vaccination on 3/20/21. On 4/5, he calls this institution to report right sided facial and tongue numbness that started the day prior. The numbness resolved the next day, however he was still unable to smile normally or close his right eyelid all the way. He has a family history of Bell's Palsy (mother and sister), with similar symptoms. Pt then presents to the clinic that same day (4/5) for an acute visit. Pt diagnosed with Bell's Palsy and given prednisone and artificial tears for treatment. Unknown if patient received dose 2 of COVID-19 vaccination.