chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Batch/Lot number: unknown), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown), on 26Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years for COVID-19 immunisation. The patient's relevant medical history included: "Diverticulosis" (unspecified if ongoing); "scolisis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "allergics" (unspecified if ongoing); "malignant neoplasm of uterus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17May2022, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included Paxlovid. Clinical course (including laboratory tests and procedures): Patient tested positive for COVID on 17May2022. Dr. prescribed Paxlovid (orally from 16May2022 to 21Jun2022 for treatment of COVID-19). Then on 31May2002 patient started having COVID symptoms again. Tested negative that day on 30May2022, patient tested positive for COVID again. Therefore had a case of rebound COVID (start date reported as 30May2022, recovering, no treatment received, resulted in none of the above) after finishing the Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination Failure (LOE) and COVID-19 cannot be ruled out.
Information has been received from a consumer concerning his 66 year old wife with no known allergies or pertinent medical history who on 20- FEB-2006 was vaccinated SC with a single dose of Zostavax. There was no concomitant medication. On 07-MAR-2007 the patient developed eczema. Medical attention was not sought, there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
ADMINISTERED PAST THE CURRENT REFRIGERATION BEYOND USE DATE AS LISTED IN EUA.
Pink swollen area left arm- below shoulder to above elbow. RX: Amoxicillin 250mg/5cc 1.5 tsp BID x 10 days. Positive strep at time of visit.
Elevated temp 10 104.1 increased fussiness less interested in breast feeding. fever responsive to TYLENOL 10/15/09 RN F/U phone call - baby acting normal; afebrile easting well.
This spontaneous report was received from a pharmacist refers to a approximately 70 year old female patient. No medical history or drug reactions were reported. On 08-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H021711, expiry: 07-MAR-2014), 0.65 ml, subcutaneously. No concomitant medications were reported. On an unknown date in April 2013, the patient arm was red, sore, painful from shoulder to fingers. The patient had a hard time lifting anything, and stated that it feels like my arm is about to fall off. Pharmacist states according to patient there are no bumps or blisters present. Pharmacist stated that the patient initially felt feverish, but no currently. Patient sought medical attention(contacted the pharmacy). Pharmacist stated there has been no treatment given as yet but the pharmacist planned to contact the patient's physician today (18-APR-2013) for treatment options. The outcome of arm was red, sore, painful from shoulder to fingers and having a hard time lifting anything was unknown. The outcome of felt feverish was reported as recovered. Additional information has been requested.
Itchy rash, swollen red circle appeared 8 days after vaccine was given. Initially, I had a large red area around injection site that went away after the third day.
101 fever for 2 days, severe body aches, chills,  weakness in arms  and legs, tachycardia 150-165 for 2 days , headaches and dizziness
Information was received from a physician concerning an 18 (also reported as 8) year old male who on 06-AUG-2002 was vaccinated with the first dose of MMR II (HSA) (lot number not reported) and on 15-MAY-2007 was vaccinated with second dose of MMR II (HSA) (lot number not reported). The patient was fever at 102. On 23-NOV-2009, lab result revealed that IgM <1:10, IgG 5.17 and serum amylase 86. On the same date, the patient diagnosed as parotitis. On 06-DEC-2009 the patient experienced mumps. Follow-up information was received which reported that the 18 (also reported as 17) year old patient on 10-JAN-2010 developed mumps. The patient was afebrile. No laboratory tests were conducted. At the time of the report, the patient's status was unknown. No further information is available.
Reported by school nurse that patient came into school clinic one hour after receiving H1N1 vaccine and reported face, fine rash to chest and bilateral arms (forearms) with itching all over. No breathing difficulties voiced. Advised BENADRYL and to see pediatrician asap.
Patient complained of lightheadedness and vomited x1 5 minutes after his first dose of Pfizer. Denies shortness of breath, denies throat swelling. Vital signs stable.  Apple juice given. Transferred to gurney via wheelchair. After 6 minutes, patient stated he feels "better" and "normal" and said he was ready to go home. He had not had breakfast or lunch.
Macula Edema R eye, steroid eye drops Prednisolone Acetate, Ketorolac Tromethamine; Ozerdex tablet shot into R eye, other steroid eye injections.  Ozerdex has reduced the swelling but not 100% yet.  Still undergoing treatment.  Seeking tx since Sept 9th 2021.  Blurry vision.
Pt. developed fever of 103 degrees w/in the first 24 hrs. after being vaccinated. Upon her exam, there was no bacterial, or other source/found that would cause this temp.
NOT MUCH APPETITE; ARM HURT; MILD NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced not much appetite, arm hurt, mild nausea, and fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild nausea, and the outcome of not much appetite, arm hurt and fatigue was not reported. This report was non-serious.
I noticed what I thought were bug bites which were very itchy. After searching online images of shingles, I had a telehealth visit with the doctor who prescribed valacyclovir. I started to take the medication immediately. The main lesion is healing. It is still painful, and I feel general malaise along with occasionally small lesions pop up or itchiness in certain areas that indicating that a rash was starting. I used over the counter topical antibiotics to treat the symptoms as well. I am not fully recovered but I am in process.
Chest pain; Left arm injection site soreness; Pain in spleen; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), ABDOMINAL PAIN (Pain in spleen) and VACCINATION SITE PAIN (Left arm injection site soreness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (experienced chest pain at that time) on 13-Mar-2020. Previously administered products included for an unreported indication: TETANUSVACCIN (Patient did not experience inflammation of spleen after vaccination.) in 2011. Concomitant products included ONDANSETRON for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ABDOMINAL PAIN (Pain in spleen). On 15-Jul-2021, the patient experienced CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Left arm injection site soreness). At the time of the report, CHEST PAIN (Chest pain), ABDOMINAL PAIN (Pain in spleen) and VACCINATION SITE PAIN (Left arm injection site soreness) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received an antibiotic, steam compresses and  The patient had spleen pain after a tetanus shot 10 years ago. The patient had no history of myocarditis or pericarditis or heart pain.  On 15-Jul-2021, the patient had left arm injection site soreness and chest pain.  After the first and second shots the patient noticed chest pain and pain in spleen.   This case was linked to MOD-2021-330668 (Patient Link).
Fever, vomiting, injection site swelling, pallor 3 days post vaccine. No specific treatment other than fever treatment.
Arm hurts; can't stay awake in the evening; Fatigue; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, sleepiness and fatigue. On an unknown date, the outcome of the pain in arm, sleepiness and fatigue were unknown.   It was unknown if the reporter considered the pain in arm, sleepiness and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and till the time of reporting her arm was hurting and could not stay awake in the evening (unusual for her).
Bells palsy type symptoms 3 weeks after 2nd dose. Increased in numbness over a week then symptoms reduced to minimal stiffness and numbness. Still continues to be stiff and numb 8 months later.
At 1112, the first dose of Pfizer vaccine was administered.  Patient stated that they could taste the vaccine immediately after it was administered.  Within 10 minutes, they reported a headache, dizziness, lightheadedness and throat tightness.  The sense of swelling in their throat worsened and she became tachycardic.  At 1135, Epi was administered.  This helped initially, and then the throat tightness worsened and she started having difficulty breathing.  EMS was called and took her for transport to the hospital at 1200.
Six hours post administration of vaccine patient complained of body aches, headache, arm where vaccine given was red and feverish. Fever of 100.7.
ringing in both ears; experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain; difficult to move arm; arm weak; I would get sharp pain when trying to lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (difficult to move arm), MUSCULAR WEAKNESS (arm weak), PAIN IN EXTREMITY (I would get sharp pain when trying to lift my arm), TINNITUS (ringing in both ears) and ARTHRALGIA (experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced LIMB DISCOMFORT (difficult to move arm), MUSCULAR WEAKNESS (arm weak), PAIN IN EXTREMITY (I would get sharp pain when trying to lift my arm) and ARTHRALGIA (experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain). On 13-Apr-2021, the patient experienced TINNITUS (ringing in both ears). At the time of the report, LIMB DISCOMFORT (difficult to move arm), MUSCULAR WEAKNESS (arm weak) and PAIN IN EXTREMITY (I would get sharp pain when trying to lift my arm) outcome was unknown and TINNITUS (ringing in both ears) and ARTHRALGIA (experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Significant follow-up appended into AER MOD-2021-073879 On 13-May-2021: Non-significant follow up accepted on 14-05-2021 :- Email id updated for the reporter
Very dizzy next AM for about 4 hours.  Lightheaded ness has persisted off and on for 3 weeks. I do have a hex of Vestibular neuritis 2 years ago.
25 y/o male with an intellectual disability who presents for his telehealth visit today with his mother after being hospitalized. He was hospitalized from 03/31 to 04/08 for about 8-9 days days  after J&J vaccine on 03/30. Reports son and her daughter-in- law were walking at the mall when her son collapsed on the sidewalk, EMS was called and the son was transported via ambulance to the ED. CT scan completed in the ED and mother was told patient had blood in his lungs. was intubated in the ICU and had feeding tube. Still awaiting medical records.
Moderate to severe soreness at injection site, body aches, low-grade fever  Took some Tylenol
Vaccine was administered on Fri approx 3 P.M.  Mom noticed arm red on Sun eve.  Came to office on Mon A.M. Upper arm at site of administration red, warm, inflamed.  No pustules or sign of secondary infection; localized reaction. Presented to office to have it checked.  No evidence for need of antibiotics at this time.  Given Benadryl; advised ot have rechecked if spreads, fever or new symptoms.
Nausea/nauseous patient unable to eat or drink for 3-4 days; Swelling in her left arm from the elbow to the shoulder; This is a spontaneous report based on the information received by Pfizer from Merck & Co., Inc.   A Pharmacy Technician (non HCP) reported that a female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; Lot Number:  W81747, Expiration Date:  01Sep2020) , intramuscular in the left arm on an unspecified date at single dose for immunisation .  The patient medical history  and concomitant medications were not reported.  The patient experienced nausea on an unknown date with outcome of unknown and  swelling in her left arm from the elbow to the shoulder (non serious) on an unspecified date with outcome of unknown. Nausea, prevented  the patient from eating or drinking for 3 or 4 days. The Patient did seek treatment, but no further details were available as to whom she saw and what treatment was given. No additional information provided.
I went to eye doctor in Dec 2021 because I was definitely noticing a problem with my eye. About 2 months later I went to a different doctor and he found the beginning of a macular hole. I lost my center vision, It became completely distorted and I ended up having surgery to repair the hole back in April 20, 2022. The next thing that happened after having surgery, I developed a fast growing case of cataracts. I ended up having surgery for the cataracts on April 3, 2023. I still have distortion in my center vision but not as bad anymore.
the worst headache of her life; jaw is also sore and hurts very very bad; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on 10Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Paracetamol (TYLENOL) and Naproxen Sodium (ALEVE). On 13Aug2021 the patient experienced the worst headache of her life since friday and her jaw were also sore and hurts very very bad. She wants to know if jaw pains are common side effects of the vaccine, because she knows that headaches were common. The outcome of both events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's first 2 Covid vaccines were Pfizer.  Her first Pfizer shot was 12/23/2020.  Her second Pfizer shot was 01/20/2021.  I did not have her vaccine card in front of me when I administered the 3rd Covid vaccine. Her 3rd vaccine was administered on 08/26/2021.  She was administered Moderna.  All literature states what you start with is what you should stick with.  She has reported no issues or concerns. Main campus noticed the error and brought it to my attention which is why I am just now reporting.
that night she started feeling N/V, HA fever and chills.  The next morning she developed a rash and the rash continued for the next 2 weeks
The vaccination triggered shingles on my head and right eye. The right ear has also got affected; The vaccination triggered shingles on my head and right eye. The right ear has also got affected; The vaccination triggered shingles on my head and right eye. The right ear has also got affected; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number: EN6205), via an unspecified route of administration on 05Mar2021 13:30 (at the age of 66-years-old) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included BP (blood pressure) abnormal, and gout. The patient has no known allergies, no COVID prior vaccination, and was not tested for COVID post-vaccination. The patient was vaccinated in a hospital. Concomitant medications included metoprolol and allopurinol. On 10Mar2021, the vaccination triggered shingles on the patient's head and right eye. The right ear also got affected. The patient was rushed to the emergency room. Later on, the patient had to visit ophthalmologist and ear specialists who prescribed medications. The events resulted in emergency room visit and doctor or other healthcare professional office/clinic visit. The patient received treatment (unspecified) for the events. Outcome of all the events was recovering.
RED, SWOLLEN, ITCHY AREA 2" X 3" AT SITE OF INJECTION LEFT DELTOID.
Patient's right arm, had severe swelling & redness from behind (R) shoulder down to (R) hand, swelling & redness on her whole (R) arm started the same day vaccine was given. Severe pain in(R) arm. Symptoms lasted longer then 48 hrs.
Received vaccine saturday 10/=1/23 at 1215 pm complained of sore right arm with swelling/red body aches saturday pm? Time. Sunday 10/22/23 complains of headache + flu symptoms. 10/23/23 at appt c/o (R) UE discomfort raised areas of erythema (R) bicep area 7cm x 9cm, warm and tender to touch. circumference of area on skin marked with blue pen/ink denied symptoms of headache or flu symptoms, continues with symptoms of warm and tender to touch ,swelling and erythema. nothing further.
shingles/rash most likely like shingles/ rash on differrent site from injection; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a elderly male patient who received Herpes zoster (Shingrix) (batch number 3D53C, expiry date 11th December 2021) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix, 3 months before the reporting date. The patient developed a rash on a different site from injection, most likely like Shingles. The reporter provided all patients identifiers as well as batch number and expiration date.
Hair is thinning; This case was reported by a consumer and described the occurrence of hair thinning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Prednisone with an associated reaction of alopecia (about 2 years ago from the reporting date).   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced hair thinning. On an unknown date, the outcome of the hair thinning was unknown.   The reporter considered the hair thinning to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient asked was there a corticosteroid in Shingrix. The reason the patient asked was that the patient had noticed that hair was thinning and the only thing the patient could think of that might be causing it was Shingrix, as the patient was not taking any new medications.  The patient knew that when the patient was on Prednisone, it caused the patient's hair to thin for a while, but fortunately, about six months after the patient finished taking the Prednisone, the hair came back to the way it was before.
Felt weak and achy; Could hardly walk from one room to the next; Really bad headache/Headache comes back every often and last for 3days; Felt weak and achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak and achy), GAIT DISTURBANCE (Could hardly walk from one room to the next), HEADACHE (Really bad headache/Headache comes back every often and last for 3days) and MYALGIA (Felt weak and achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-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 ASTHENIA (Felt weak and achy), GAIT DISTURBANCE (Could hardly walk from one room to the next), HEADACHE (Really bad headache/Headache comes back every often and last for 3days) and MYALGIA (Felt weak and achy). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt weak and achy), GAIT DISTURBANCE (Could hardly walk from one room to the next), HEADACHE (Really bad headache/Headache comes back every often and last for 3days) and MYALGIA (Felt weak and achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient reported progressive right-arm weakness and difficulty walking x 2 days. Patient has prior history of focal seizures to right arm (last 1/2021). On imaging, it was shown: CT head wo contrast today reveals this patient has extensive evolving tumor in the left hemisphere, including what may be progressive subependymoma or a discernible disease in the left atrium. There is mass effect upon the left lateral ventricle and either stable or slightly progressive left right midline shift that may be a contributor to the patient's weakness. Patient actively admitted for work up of above.